Szybki test przepływowy na covid-19
Diagnostyka i diagnoza

Szybkie testy przepływowe (LFT) na COVID-19 to immunochromatograficzne testy antygenowe wykrywające białka wirusa SARS-CoV-2, głównie nukleokapsydu, w próbkach z nosa lub gardła. Wynik uzyskuje się w 5-30 minut, co umożliwia szybkie decyzje kliniczne, zwłaszcza w pierwszym tygodniu od wystąpienia objawów, gdy miano wirusa jest najwyższe (czułość 76-82% u pacjentów objawowych, 57-68% u bezobjawowych; swoistość około 99,6%). Testy te charakteryzują się wysoką swoistością (>99%), niskim kosztem i możliwością wykonania poza laboratorium, co czyni je przydatnymi w diagnostyce punktu opieki (POC) oraz masowych badaniach przesiewowych. Wynik pozytywny zwykle nie wymaga potwierdzenia PCR, natomiast wynik negatywny u osób z objawami powinien być zweryfikowany testem molekularnym. Testy te mają ograniczoną czułość przy niskim mianie wirusa oraz zmniejszoną skuteczność wobec niektórych wariantów, np. Omicron.

  1. Szybki test przepływowy na COVID-19 – Diagnostyka
    1. Zasada działania testów przepływowych
  2. Rodzaje szybkich testów przepływowych na COVID-19
    1. Testy antygenowe
    2. Testy przeciwciałowe
    3. Testy kombinowane
  3. Wydajność diagnostyczna testów przepływowych
    1. Czułość i swoistość testów
    2. Czynniki wpływające na wydajność testów
    3. Interpretacja wyników
  4. Zastosowanie kliniczne testów przepływowych
    1. Diagnostyka indywidualna
    2. Badania przesiewowe i nadzór
    3. Samodzielne testowanie
  5. Zalety i ograniczenia testów przepływowych
    1. Zalety szybkich testów przepływowych
    2. Ograniczenia i wyzwania
  6. Perspektywy rozwoju i przyszłość testów przepływowych
    1. Innowacje i ulepszenia technologii
    2. Rola testów przepływowych w przyszłości
  7. Rekomendacje dotyczące stosowania
    1. Wytyczne kliniczne
    2. Praktyczne wskazówki
  8. Regulacje i standaryzacja
    1. Autoryzacje i certyfikacje
    2. Standardy jakości i kontrola
  9. Wnioski końcowe
    1. Kolejne rozdziały

Szybki test przepływowy na COVID-19 – Diagnostyka

Szybki test przepływowy na COVID-19 (ang. lateral flow test, LFT) to forma szybkiego testu antygenowego służącego do wykrywania zakażenia wirusem SARS-CoV-2. Testy te opierają się na technologii immunochromatografii przepływu bocznego, zapewniającej szybkie wyniki w czasie od 5 do 30 minut. Ze względu na swoje cechy, takie jak niski koszt, łatwość wykonania i szybkość uzyskania wyniku, testy przepływowe stały się istotnym narzędziem w diagnostyce i kontroli pandemii COVID-19, szczególnie w kontekście masowych badań przesiewowych.12

Zasada działania testów przepływowych

Szybkie testy przepływowe na COVID-19 opierają się na metodzie immunochromatografii, która wykrywa obecność antygenów (białek) wirusa SARS-CoV-2 w próbce pobranej z dróg oddechowych pacjenta. Typowy test przepływowy składa się z kilku kluczowych elementów: podkładki próbkowej, podkładki koniugatu, membrany nitrocelulozowej (NC), podkładki absorpcyjnej, plastikowego podłoża oraz odczynników biologicznych.3

Proces testowania przebiega następująco:

  1. Pobiera się próbkę z nosa lub gardła pacjenta za pomocą wymazówki
  2. Wymazówkę umieszcza się w buforze ekstrakcyjnym w celu uwolnienia ewentualnych antygenów wirusowych
  3. Kilka kropel zawiesiny nanosi się na podkładkę próbkową testu
  4. Płyn przemieszcza się przez test kapilarnie, przechodząc przez strefę koniugatu zawierającą przeciwciała znakowane (najczęściej złotem koloidalnym)
  5. Jeśli w próbce obecne są antygeny wirusa, wiążą się one z przeciwciałami znakowanymi
  6. Kompleksy antygen-przeciwciało przemieszczają się dalej i zatrzymują w linii testowej, gdzie znajdują się unieruchomione przeciwciała specyficzne wobec antygenów SARS-CoV-2
  7. Widoczna linia w strefie testowej (T) oznacza wynik pozytywny4

W przypadku testów antygenowych na COVID-19, najczęściej wykrywane są białka nukleokapsydu wirusa SARS-CoV-2, choć niektóre testy mogą być skierowane również na białko kolca (S). Zasada opiera się na metodzie kanapkowej z podwójnym przeciwciałem, gdzie antygen wirusa działa jak most pomiędzy przeciwciałami unieruchomionymi na teście a przeciwciałami znakowanymi z podkładki koniugatu.5

Rodzaje szybkich testów przepływowych na COVID-19

Testy antygenowe

Testy antygenowe wykrywają białka wirusa SARS-CoV-2 bezpośrednio w próbce pobranej od pacjenta. Są one szczególnie skuteczne w wykrywaniu zakażenia u osób z wysokim mianem wirusa, co zwykle ma miejsce w pierwszych dniach od wystąpienia objawów. Testy te służą przede wszystkim do wykrywania aktywnego zakażenia i potencjalnej zakaźności pacjenta.67

Zalety testów antygenowych:

  • Szybki wynik (zwykle w ciągu 15-30 minut)
  • Nie wymagają specjalistycznego sprzętu laboratoryjnego
  • Możliwość wykonania w miejscu opieki (point-of-care)
  • Niski koszt w porównaniu do testów molekularnych
  • Dobra swoistość (zwykle 98-99%)8

Ograniczenia testów antygenowych:

  • Niższa czułość w porównaniu do testów RT-PCR (70-88% dla osób objawowych, 57-68% dla bezobjawowych)9
  • Wyższa częstość wyników fałszywie ujemnych, szczególnie w przypadku niskiego miana wirusa10
  • Zmniejszona wydajność w przypadku niektórych wariantów wirusa, np. Omicron11

Testy przeciwciałowe

Testy przeciwciałowe (serologiczne) wykrywają przeciwciała IgM i/lub IgG wytwarzane przez układ odpornościowy pacjenta w odpowiedzi na infekcję SARS-CoV-2. W przeciwieństwie do testów antygenowych, nie wskazują one na aktywne zakażenie, lecz na przebyte zakażenie lub odpowiedź immunologiczną po szczepieniu.12

Testy te są użyteczne w:

  • Identyfikacji osób, które przebyły zakażenie COVID-19
  • Ocenie odpowiedzi immunologicznej po szczepieniu
  • Badaniach epidemiologicznych dotyczących rozprzestrzeniania się wirusa w populacji13

Czułość testów przeciwciałowych wzrasta wraz z czasem od początku objawów – od 18,8-40,6% w ciągu pierwszych 3 dni, do 80,3-96,4% po upływie 14 dni od wystąpienia objawów.14

Testy kombinowane

Testy kombinowane pozwalają na jednoczesne wykrywanie kilku patogenów, np. SARS-CoV-2, wirusa grypy typu A i B. Mają one szczególne znaczenie w sezonach zwiększonej zachorowalności na infekcje dróg oddechowych, kiedy istnieje potrzeba różnicowania COVID-19 od innych chorób wirusowych o podobnych objawach.1516

Przykładem takiego testu jest Healgen® COVID-19/Flu A&B Ag Combo, który wykrywa i różnicuje antygeny nukleoproteiny wirusa grypy A i B oraz antygen nukleokapsydu SARS-CoV-2 bezpośrednio z próbek wymazu z nosa.17

Wydajność diagnostyczna testów przepływowych

Czułość i swoistość testów

Czułość i swoistość szybkich testów przepływowych na COVID-19 są kluczowymi parametrami determinującymi ich przydatność diagnostyczną. Światowa Organizacja Zdrowia (WHO) zaleca, aby testy antygenowe charakteryzowały się czułością ≥80% i swoistością ≥97%.18

Metaanalizy i przeglądy systematyczne wykazują, że czułość testów przepływowych jest zróżnicowana i zależy od wielu czynników:

  • Czułość dla pacjentów z objawami: 76-82%
  • Czułość dla pacjentów bezobjawowych: 57-68%
  • Swoistość ogólna: około 99,6%1920

Badania wskazują, że testy przepływowe osiągają najwyższą czułość w pierwszym tygodniu od wystąpienia objawów, gdy miano wirusa jest najwyższe (około 82% potwierdzonych przypadków miało pozytywne wyniki testów antygenowych).21

Warto zauważyć, że czułość testów przepływowych jest niższa u osób zaszczepionych przeciwko COVID-19 w porównaniu do osób niezaszczepionych.22

Czynniki wpływające na wydajność testów

Na skuteczność szybkich testów przepływowych wpływa szereg czynników:

  1. Czas wykonania testu od początku infekcji – testy są najbardziej skuteczne w pierwszym tygodniu od wystąpienia objawów, gdy miano wirusa jest najwyższe23
  2. Jakość pobrania próbki – nieprawidłowe pobranie materiału może prowadzić do wyników fałszywie ujemnych24
  3. Miano wirusa u pacjenta – wyższa czułość testów przy wysokim mianie wirusa (wartości Ct poniżej 22 w teście RT-PCR)25
  4. Wariant wirusa – niektóre warianty mogą być trudniejsze do wykrycia, np. dla wariantu Omicron przy niskim mianie wirusa czułość wynosiła zaledwie 0-23,1%26
  5. Jakość testu i producent – istnieją znaczące różnice między testami różnych producentów27

Badanie opublikowane w BMJ wykazało, że test Innova pominąłby 20% osób z dodatnim wynikiem hodowli wirusa w ośrodkach NHS Test-and-Trace, 29% osób bezobjawowych w masowych badaniach miejskich oraz 81% osób bezobjawowych w badaniach przesiewowych na uniwersytetach.28

Interpretacja wyników

Prawidłowa interpretacja wyników szybkich testów przepływowych jest kluczowa dla ich skutecznego wykorzystania klinicznego:

Wynik pozytywny:

  • Wskazuje na obecność antygenów wirusa SARS-CoV-2 w próbce
  • Pacjent jest najprawdopodobniej zakażony i potencjalnie zakaźny
  • Ze względu na wysoką swoistość testów (>99%), wynik pozytywny zwykle nie wymaga potwierdzenia testem PCR29
  • Pacjent powinien poddać się izolacji zgodnie z lokalnymi wytycznymi (zazwyczaj 5-7 dni)30

Wynik negatywny:

  • Wskazuje, że antygeny SARS-CoV-2 nie zostały wykryte lub ich poziom jest poniżej progu wykrywalności testu
  • Nie wyklucza całkowicie zakażenia, szczególnie przy niskim mianie wirusa lub wczesnej fazie infekcji
  • U osób z objawami sugerującymi COVID-19 i ujemnym wynikiem testu przepływowego zaleca się wykonanie testu PCR31
  • Negatywny wynik nie powinien być wykorzystywany jako podstawa do rezygnacji z innych środków zapobiegawczych32

W przypadku pacjentów bezobjawowych zaleca się wykonywanie regularnych, seryjnych testów, aby zwiększyć szansę wykrycia infekcji. Dla pacjentów kwalifikujących się do leczenia COVID-19, przy utrzymujących się objawach i ujemnym wyniku pierwszego testu, zaleca się wykonanie łącznie trzech testów w ciągu trzech dni (jeden test dziennie).33

Zastosowanie kliniczne testów przepływowych

Diagnostyka indywidualna

Szybkie testy przepływowe znajdują zastosowanie w diagnostyce indywidualnej pacjentów z podejrzeniem COVID-19, szczególnie w warunkach podstawowej opieki zdrowotnej. Badania wykazały, że testy antygenowe przepływowe skutecznie wykrywają COVID-19, gdy są stosowane na początku infekcji i wkrótce po wystąpieniu objawów, zapewniając dokładność porównywalną z laboratoryjnymi testami PCR.34

Główne zastosowania w diagnostyce indywidualnej obejmują:

  • Szybką diagnostykę u pacjentów objawowych w ciągu pierwszych 5-7 dni od wystąpienia objawów35
  • Szybkie podejmowanie decyzji klinicznych dotyczących izolacji i leczenia36
  • Rozpoznawanie przypadków wymagających wdrożenia leczenia przeciwwirusowego (w ciągu pierwszych 5 dni od wystąpienia objawów)37
  • Identyfikację pacjentów zakażonych w warunkach ograniczonego dostępu do testów PCR38

Szybkie testy przepływowe są szczególnie przydatne w placówkach podstawowej opieki zdrowotnej, gdzie szybki wynik może wpłynąć na decyzje kliniczne i zapobiec rozprzestrzenianiu się wirusa.39

Badania przesiewowe i nadzór

Szybkie testy przepływowe odegrały kluczową rolę w prowadzeniu badań przesiewowych na dużą skalę, zarówno w populacjach ogólnych, jak i w określonych środowiskach, takich jak placówki opieki zdrowotnej, szkoły czy zakłady pracy.40

Główne zastosowania w badaniach przesiewowych obejmują:

  • Masowe badania populacyjne (np. pilotażowy program w Liverpoolu w Wielkiej Brytanii czy ogólnokrajowe badania na Słowacji)41
  • Regularne badania pracowników służby zdrowia i placówek opieki długoterminowej42
  • Badania przesiewowe w szkołach i na uniwersytetach43
  • Monitorowanie trendów zachorowań w społecznościach44
  • Badania kontaktów osób zakażonych45

Pomimo mniejszej czułości w porównaniu do testów PCR, szybkie testy przepływowe mogą być skutecznym narzędziem w zapobieganiu transmisji wirusa w społeczności. Ich główną zaletą jest możliwość częstego wykonywania, co zwiększa szansę wykrycia zakażenia w fazie, gdy pacjent jest najbardziej zakaźny.46

Samodzielne testowanie

Jednym z przełomowych zastosowań szybkich testów przepływowych podczas pandemii COVID-19 było ich wprowadzenie do samodzielnego użytku domowego. W wielu krajach testy te stały się dostępne bez recepty, umożliwiając społeczeństwu regularne testowanie się w domu.4748

Samodzielne testy domowe oferują szereg korzyści:

  • Zwiększona dostępność diagnostyki, szczególnie w obszarach o ograniczonym dostępie do placówek medycznych49
  • Możliwość szybkiej izolacji w przypadku wyniku pozytywnego, co ogranicza transmisję wirusa50
  • Zwiększona częstotliwość testowania dzięki wygodzie i łatwości wykonania51
  • Wsparcie dla powrotu do normalnego funkcjonowania społeczeństwa52

Przykładami testów przeznaczonych do samodzielnego użytku są BinaxNOW COVID-19 Self Test (Abbott), iHealth COVID-19 Antigen Rapid Test czy QuickVue COVID-19 Test, które otrzymały autoryzację do użytku domowego bez recepty.5354

Testy do samodzielnego użytku zazwyczaj zawierają proste instrukcje i wszystkie niezbędne komponenty do przeprowadzenia badania w domu, a wynik jest dostępny w ciągu 10-15 minut.55

Zalety i ograniczenia testów przepływowych

Zalety szybkich testów przepływowych

Szybkie testy przepływowe na COVID-19 posiadają wiele zalet, które uczyniły je popularnym narzędziem w walce z pandemią:

  • Szybkość uzyskania wyniku – rezultaty dostępne w ciągu 15-30 minut, co umożliwia szybkie podejmowanie decyzji klinicznych56
  • Niski koszt – znacznie tańsze niż testy molekularne, co umożliwia szersze zastosowanie, szczególnie w krajach o ograniczonych zasobach57
  • Brak potrzeby specjalistycznego sprzętu – testy mogą być wykonywane poza laboratoriami, w miejscu opieki nad pacjentem58
  • Łatwość użycia – proste procedury wykonania, niewymagające specjalistycznego przeszkolenia59
  • Mobilność – możliwość stosowania w różnych warunkach, w tym w terenie, domach opieki czy szkołach60
  • Wysoka swoistość – niskie ryzyko wyników fałszywie dodatnich (>99%)61
  • Wykrywanie osób najbardziej zakaźnych – najwyższa czułość u osób z wysokim mianem wirusa, które stanowią największe ryzyko transmisji62

Testy przepływowe okazały się szczególnie przydatne w warunkach ograniczonych zasobów, gdzie dostęp do testów molekularnych jest utrudniony, oraz w sytuacjach wymagających szybkiej diagnostyki i izolacji osób zakażonych.63

Ograniczenia i wyzwania

Pomimo wielu zalet, szybkie testy przepływowe mają również istotne ograniczenia, które należy uwzględnić podczas ich stosowania:

  • Niższa czułość – mniejsza dokładność w porównaniu do testów RT-PCR, szczególnie przy niskim mianie wirusa64
  • Zmienność jakości testów – znaczące różnice w czułości i swoistości między produktami różnych producentów65
  • Ryzyko wyników fałszywie ujemnych – szczególnie u osób bezobjawowych lub w początkowej fazie zakażenia66
  • Wyniki zależne od czasu wykonania – optymalna czułość w pierwszym tygodniu objawów, zmniejszająca się w późniejszych fazach infekcji67
  • Subiektywna interpretacja wyników – szczególnie w przypadku słabo widocznych linii testowych68
  • Ograniczona skuteczność dla niektórych wariantów – zmniejszona czułość dla niektórych wariantów, np. Omicron69
  • Problemy z dostępem do dobrze scharakteryzowanych próbek do walidacji testów70

Te ograniczenia podkreślają potrzebę ostrożnej interpretacji wyników testów przepływowych, szczególnie wyników ujemnych, oraz dalszego doskonalenia technologii w celu zwiększenia ich czułości i niezawodności.71

Perspektywy rozwoju i przyszłość testów przepływowych

Innowacje i ulepszenia technologii

Doświadczenia z pandemii COVID-19 przyczyniły się do intensywnego rozwoju technologii testów przepływowych. Obecnie obserwujemy szereg innowacyjnych rozwiązań mających na celu poprawę ich skuteczności:72

  • Integracja z technologiami cyfrowymi – automatyczna interpretacja wyników za pomocą aplikacji mobilnych i sztucznej inteligencji7374
  • Wykorzystanie kropek kwantowych (QDs) – zwiększenie czułości i specyficzności testów przepływowych75
  • Łączenie technologii CRISPR z testami przepływowymi – zwiększenie czułości testów do poziomów porównywalnych z PCR7677
  • Testy multiparametryczne – jednoczesne wykrywanie wielu patogenów w jednym teście78
  • Udoskonalenia w zakresie biomarkerów – opracowanie testów wykrywających nowe biomarkery SARS-CoV-279
  • Automatyczne czytniki testów – eliminacja błędów interpretacji i subiektywnej oceny wyników80

Te innowacje mają na celu zwiększenie czułości testów, poprawę ich wiarygodności oraz rozszerzenie zakresu zastosowań klinicznych, co może znacząco przyczynić się do rozwoju diagnostyki point-of-care.81

Rola testów przepływowych w przyszłości

Doświadczenia zdobyte podczas pandemii COVID-19 pokazują, że szybkie testy przepływowe będą odgrywać ważną rolę w przyszłości diagnostyki medycznej:82

  • Gotowość na przyszłe pandemie – szybsza adaptacja i wdrażanie testów w przypadku pojawienia się nowych zagrożeń83
  • Rozszerzenie zakresu zastosowań – wykrywanie innych chorób zakaźnych, takich jak grypa, RSV, malaria, gruźlica czy HIV8485
  • Diagnostyka w miejscu opieki – zwiększona rola testów POC w podstawowej opiece zdrowotnej86
  • Diagnostyka domowa – rozszerzenie dostępności testów do samodzielnego użytku dla różnych schorzeń87
  • Integracja z systemami opieki zdrowotnej – lepsza koordynacja wyników testów z systemami informacji medycznej88
  • Wsparcie dla diagnostyki w krajach o ograniczonych zasobach – zwiększenie dostępności niedrogiej diagnostyki w regionach o ograniczonej infrastrukturze laboratoryjnej89

Perspektywa rozwoju kolejnej generacji testów przepływowych (tzw. „Lateral Flow 2.0”) wskazuje na ich rosnące znaczenie w diagnostyce medycznej, zarówno w kontekście chorób zakaźnych, jak i innych schorzeń, takich jak choroby sercowo-naczyniowe, nowotwory czy sepsa.9091

Rekomendacje dotyczące stosowania

Wytyczne kliniczne

Wytyczne kliniczne dotyczące stosowania szybkich testów przepływowych na COVID-19 opracowane zostały przez liczne organizacje zdrowotne, w tym WHO i towarzystwa naukowe. Kluczowe rekomendacje obejmują:9293

  • Zastosowanie u pacjentów objawowych – zalecane w ciągu pierwszych 5-7 dni od wystąpienia objawów, gdy miano wirusa jest najwyższe94
  • Interpretacja wyników – wynik dodatni można wykorzystać do podejmowania decyzji terapeutycznych bez potwierdzenia, wynik ujemny nie wyklucza całkowicie zakażenia95
  • Strategie powtarzanych testów – w przypadku wyniku ujemnego u osoby z objawami zaleca się powtórzenie testu w ciągu 48-72 godzin lub wykonanie testu PCR96
  • Badania przesiewowe – testy mogą być stosowane w określonych populacjach wysokiego ryzyka, choć preferowane są testy PCR, jeśli są dostępne i mogą zapewnić terminowe wyniki97
  • Samodzielne pobieranie próbek – dopuszczalne jest zarówno samodzielne pobieranie próbek pod nadzorem, jak i bez nadzoru98

Wytyczne podkreślają, że decyzja o zastosowaniu szybkiego testu przepływowego powinna uwzględniać lokalną sytuację epidemiologiczną, dostępność testów PCR oraz konkretne zastosowanie kliniczne.99

Praktyczne wskazówki

Praktyczne zalecenia dotyczące wykonywania i interpretacji szybkich testów przepływowych na COVID-19:100101

  • Właściwe pobranie próbki – dokładne przestrzeganie instrukcji dotyczących głębokości i techniki pobrania wymazu z nosa lub gardła
  • Prawidłowy czas reakcji – odczytywanie wyniku zgodnie z zaleceniami producenta, zwykle po 15-30 minutach
  • Ocena jakości testu – sprawdzenie obecności linii kontrolnej, wskazującej na prawidłowe przeprowadzenie testu
  • Przechowywanie testów – zapewnienie odpowiednich warunków przechowywania zgodnie z zaleceniami producenta
  • Interpretacja słabych linii – traktowanie nawet słabo widocznej linii testowej jako wyniku dodatniego102
  • Seryjne testowanie – w przypadku osób bezobjawowych lub narażonych na kontakt z zakażonymi zaleca się powtarzanie testów w odstępach 48-godzinnych103

Szczególnej uwagi wymaga fakt, że ujemny wynik testu przepływowego nie powinien być wykorzystywany jako podstawa do rezygnacji z innych środków zapobiegawczych, zwłaszcza w przypadku występowania objawów sugerujących COVID-19.104

Regulacje i standaryzacja

Autoryzacje i certyfikacje

Szybkie testy przepływowe na COVID-19 podlegają rygorystycznym procesom autoryzacji i certyfikacji przez krajowe i międzynarodowe organy regulacyjne:105

  • Autoryzacja FDA – w USA większość testów otrzymała Emergency Use Authorization (EUA) od Agencji Żywności i Leków106
  • Znak CE – w Europie testy muszą spełniać wymagania dyrektywy IVD i posiadać oznaczenie CE107
  • Wytyczne WHO – testy powinny spełniać minimalne wymagania wydajności określone przez Światową Organizację Zdrowia108
  • Krajowe procesy walidacji – w niektórych krajach testy podlegają dodatkowej walidacji przez krajowe laboratoria referencyjne109

Warto zauważyć, że w odpowiedzi na pandemię COVID-19 wiele krajów wprowadziło przyspieszone procedury zatwierdzania testów diagnostycznych, co umożliwiło szybsze wprowadzenie ich na rynek, przy jednoczesnym zapewnieniu odpowiednich standardów jakości i bezpieczeństwa.110111

Standardy jakości i kontrola

Aby zapewnić wysoką jakość i wiarygodność szybkich testów przepływowych, stosowane są następujące standardy i mechanizmy kontroli:112

  • Wymagania dotyczące wydajności – minimalna czułość i swoistość określona przez organy regulacyjne (np. WHO zaleca czułość ≥80% i swoistość ≥97%)113
  • Standaryzacja produkcji – kontrola jakości materiałów i procesu produkcyjnego114
  • Niezależna walidacja – testowanie przez niezależne laboratoria w celu weryfikacji deklarowanych parametrów115
  • Monitorowanie skuteczności dla nowych wariantów – ciągła ocena zdolności testów do wykrywania nowych wariantów SARS-CoV-2116
  • Systemy zgłaszania problemów – mechanizmy raportowania i monitorowania niepożądanych zdarzeń związanych z testami117

Standardy jakości mają kluczowe znaczenie dla zapewnienia wiarygodności wyników testów przepływowych, szczególnie w kontekście ich zastosowania na dużą skalę w zwalczaniu pandemii.118

Wnioski końcowe

Szybkie testy przepływowe na COVID-19 odegrały istotną rolę w walce z pandemią, oferując szybką, dostępną i relatywnie tanią metodę diagnostyczną. Pomimo ograniczeń związanych z niższą czułością w porównaniu do testów PCR, ich zdolność do wykrywania osób z wysokim mianem wirusa, potencjalnie najbardziej zakaźnych, czyni je wartościowym narzędziem w kontroli transmisji wirusa w społeczeństwie.119120

Doświadczenia zdobyte podczas pandemii COVID-19 przyczyniły się do intensywnego rozwoju technologii testów przepływowych, prowadząc do poprawy ich czułości, specyficzności oraz użyteczności klinicznej. Trwające prace nad integracją z nowoczesnymi technologiami cyfrowymi, automatyczną interpretacją wyników oraz nowymi biomarkerami wskazują na rosnące znaczenie tych testów w przyszłości diagnostyki medycznej.121122

Szybkie testy przepływowe będą nadal stanowić ważne narzędzie w gotowości na przyszłe epidemie i pandemie, a także w diagnostyce innych chorób zakaźnych. Ich dostępność, łatwość użycia i szybkość uzyskiwania wyników czynią je szczególnie wartościowymi w warunkach ograniczonych zasobów oraz w sytuacjach wymagających natychmiastowych decyzji klinicznych.123124

Kolejne rozdziały

Zapraszamy do dalszego czytania naszego leksykonu.

Wybierz kolejny rozdział z menu poniżej, aby otworzyć nową podstronę kompedium wiedzy i uzyskać szczegółowe informację o leku, substancji lub chorobie.

  1. 11.04.2026
  2. www.leksykon.com.pl

Materiały źródłowe

  • #1 COVID-19 rapid antigen test – Wikipedia
    https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test
    COVID-19 rapid antigen tests or RATs, also frequently called COVID-19 lateral flow tests or LFTs, are rapid antigen tests used to detect SARS-CoV-2 infection (COVID-19). They are quick to implement with minimal training, cost a fraction of other forms of COVID-19 testing, and give users a result within 5–30 minutes. RATs have been used in several countries as part of mass testing or population-wide screening approaches. […] COVID-19 rapid antigen tests (RATs) have been widely used for diagnosis of COVID-19. The World Health Organization (WHO) COVID-19 Case Definition states that a person with a positive RAT (also known as an antigen rapid diagnostic test or Antigen-RDT) can be considered a „confirmed case of SARS-CoV-2 infection” in two ways. […] Despite this, COVID-19 RATs remain valuable in finding people who would otherwise not know they were infected, helping to prevent further transmission. The tests are more sensitive in the symptomatic and transmissive stages of disease when the viral load is higher.
  • #2 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner
    https://www.nature.com/articles/s44222-022-00007-3
    Lateral flow tests (LFTs) were adopted at an unprecedented scale during the COVID-19 pandemic, enabling access to testing beyond healthcare settings. […] The acceptability and feasibility of large-scale testing with lateral flow tests (LFTs) for clinical and public health purposes has been demonstrated during the COVID-19 pandemic. […] Key barriers to COVID-19 LFT development and adoption include lack of access to well characterized samples, limited accuracy, lack of connectivity, lack of evidence of cost-effectiveness, regulatory delays and centralized manufacturing capabilities. […] LFTs could also play an important part in the detection of other diseases of epidemic potential and antimicrobial resistance. […] The accuracy and, in particular, the sensitivity of LFTs is lower than that of reference RT-PCR methods, ranging between 34.1% and 88.1% for SARS-CoV-2 antigen LFTs, with an overall specificity of 99.6%.
  • #3 Frontiers | Recent Progress on Rapid Lateral Flow Assay-Based Early Diagnosis of COVID-19
    https://www.frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2022.866368/full
    In this work, LFA that could be used for large-scale screening of COVID-19 at home, school, and under various non-laboratory scenarios owing to its simplicity, convenience, rapidity, and cost-efficiency is discussed. […] The principles, advantages and disadvantages of these methods will be discussed in detail to provide guidance and suggestions for the prevention and transmission control of the COVID-19 pandemic in the post-pandemic era from the prospective of a diagnostic strategy. […] An LFA test strip typically comprises a sample pad, a conjugate pad, a nitrocellulose (NC) membrane, an absorbent pad, a plastic backing, and biological reagents. […] Currently, it is one of the most helpful tools for controlling the spread of COVID-19. […] The principle of LFAs antigen detection is based on the double-antibody sandwich method. […] Therefore, there is an urgent need to develop an approach to determine antigens with high sensitivity and specificity. The LFA-based method has unique advantages in antigen detection, such as convenient, speed, and suitability for various application scenarios.
  • #4 How Do Rapid Antigen Tests Work? | Today’s Clinical Lab
    https://www.clinicallab.com/how-do-rapid-antigen-tests-work-26279
    For COVID-19 or influenza, a sample is taken with a nasopharyngeal swab. The swab is then agitated in a small amount of liquid to suspend the sample and any virus particles. After a couple of minutes, that liquid, called the analyte, is placed in the well at the bottom of the testing cartridge. […] The dehydrated test components include antibodies conjugated to a visualization component (usually gold colloid), which bind to the target antigen. For example, the Abbott rapid antigen test has human IgG specific antibodies to SARS-CoV-2 conjugated to gold colloid. […] For the Abbott COVID-19 test, mouse monoclonal anti-SARS-CoV-2 antibodies are immobilized along the test strip. As the analyte passes across the test line, any SARS-CoV-2 antigen targets in the analyte will bind to the conjugated test antibodies. This means that at the test line, the SARS-CoV-2 antigens act like a bridge between the immobilized test antigens and the gold-conjugated visualization antibodies from the conjugate release pad. This multi-part complex gets stuck in place at the test line and the accumulation of the gold-conjugate antibodies becomes visible, indicating a positive result.
  • #5 How Do Rapid Antigen Tests Work? | Today’s Clinical Lab
    https://www.clinicallab.com/how-do-rapid-antigen-tests-work-26279
    For COVID-19 or influenza, a sample is taken with a nasopharyngeal swab. The swab is then agitated in a small amount of liquid to suspend the sample and any virus particles. After a couple of minutes, that liquid, called the analyte, is placed in the well at the bottom of the testing cartridge. […] The dehydrated test components include antibodies conjugated to a visualization component (usually gold colloid), which bind to the target antigen. For example, the Abbott rapid antigen test has human IgG specific antibodies to SARS-CoV-2 conjugated to gold colloid. […] For the Abbott COVID-19 test, mouse monoclonal anti-SARS-CoV-2 antibodies are immobilized along the test strip. As the analyte passes across the test line, any SARS-CoV-2 antigen targets in the analyte will bind to the conjugated test antibodies. This means that at the test line, the SARS-CoV-2 antigens act like a bridge between the immobilized test antigens and the gold-conjugated visualization antibodies from the conjugate release pad. This multi-part complex gets stuck in place at the test line and the accumulation of the gold-conjugate antibodies becomes visible, indicating a positive result.
  • #6 Frontiers | Recent Progress on Rapid Lateral Flow Assay-Based Early Diagnosis of COVID-19
    https://www.frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2022.866368/full
    Generally, in the early stage of SARS-CoV-2 infection, when the nucleic acid test is negative and the antibody level is undetectable, antigen detection has a specific value. […] A series of experiments were performed to evaluate the sensitivity and specificity of the SARS-CoV-2 antigen diagnostic test. […] As more LFA-based antigen detection kits are approved, they will be more widely used in pandemic prevention, especially in public places such as homes and airports.
  • #7 Development and Efficacy of Lateral Flow Point-of-Care Testing Devices for Rapid and Mass COVID-19 Diagnosis by the Detections of SARS-CoV-2 Antigen and Anti-SARS-CoV-2 Antibodies
    https://pubmed.ncbi.nlm.nih.gov/34679458/
    The COVID-19 pandemic is an ongoing global pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 2020-2021. […] Diagnosis via viral nucleic acid amplification tests (NAATs) is frequently employed and considered the standard procedure. […] However, with an increasing urge for point-of-care tests, rapid and cheaper immunoassays are widely utilized, such as lateral flow immunoassay (LFIA), which can be used for rapid, early, and large-scale detection of SARS-CoV-2 infection. […] The diagnostic sensitivity and specificity of the commercial LFIA tests are outlined and compared. […] Generally, LFIA antigen tests for SARS-CoV-2 are less sensitive than viral NAATs, the „gold standard” for clinical COVID-19 diagnosis. […] However, antigen tests can be used for rapid and mass testing in high-risk congregate housing to quickly identify people with COVID-19, implementing infection prevention and control measures, thus preventing transmission.
  • #8 COVID-19 rapid antigen test – Wikipedia
    https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test
    Although the specificity of RATs are high (98%-99%), in 2020 RATs were criticized for having a sensitivity as low as 50%; that is, if people with COVID-19 as determined by a positive PCR test were also tested with a RAT, about half the time the RAT would be negative. […] As of 2022, systematic reviews determined that the pooled sensitivities of RATs were 70%-72%. […] The sensitivity of the RAT was lower in persons who were vaccinated against COVID-19 than in persons who were not vaccinated against COVID-19. […] The sensitivity was higher for symptomatic people (76%-82%) than for asymptomatic people (57%-68%). […] The World Health Organization (WHO) recommends RATs with „≥ 80% sensitivity”, many RATs do not meet the WHO recommendation. […] In November 2020, a new, marginally more infectious strain of SARS-CoV-2 was identified in the United Kingdom, the SARS-CoV-2 Alpha variant.
  • #9 COVID-19 rapid antigen test – Wikipedia
    https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test
    Although the specificity of RATs are high (98%-99%), in 2020 RATs were criticized for having a sensitivity as low as 50%; that is, if people with COVID-19 as determined by a positive PCR test were also tested with a RAT, about half the time the RAT would be negative. […] As of 2022, systematic reviews determined that the pooled sensitivities of RATs were 70%-72%. […] The sensitivity of the RAT was lower in persons who were vaccinated against COVID-19 than in persons who were not vaccinated against COVID-19. […] The sensitivity was higher for symptomatic people (76%-82%) than for asymptomatic people (57%-68%). […] The World Health Organization (WHO) recommends RATs with „≥ 80% sensitivity”, many RATs do not meet the WHO recommendation. […] In November 2020, a new, marginally more infectious strain of SARS-CoV-2 was identified in the United Kingdom, the SARS-CoV-2 Alpha variant.
  • #10 Test performance of lateral flow rapid antigen tests for COVID-19 in Welsh adult care home staff using routine surveillance data | PLOS One
    https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0290406
    These results suggest that whilst lateral flow tests are effective for identifying SARS-COV-2 infections with high viral loads, they are not effective at identifying cases with a low viral load. […] When an LFT provides a negative result, false negatives should be considered and additional diagnostic tests performed.
  • #11 COVID-19 rapid antigen test – Wikipedia
    https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test
    A study published in 2022 found that the sensitivities of six rapid antigen detection tests were 70.0%-92.9% for the Delta variant and 69.6%-78.3% for the Omicron variant across a range of viral loads; however, for Omicron samples with a low viral load, the sensitivities were 0.0%-23.1%. […] If a COVID-19 RAT is used outside manufacturer recommendations, the result can be false positive. […] Some have raised concerns about the slow deployment and uptake of RATs, and the potential loss of life that might have occurred as a result. […] Various concerns have been raised related to the safety of chemical components contained within RAT kits, which can be toxic to humans if not properly used. […] COVID-19 rapid antigen tests (RATs) detect antigenic proteins on the surface of or in the interior of the SARS-CoV-2 coronavirus. […] A typical COVID-19 RAT is a lateral flow test (LFT).
  • #12 Development and Efficacy of Lateral Flow Point-of-Care Testing Devices for Rapid and Mass COVID-19 Diagnosis by the Detections of SARS-CoV-2 Antigen and Anti-SARS-CoV-2 Antibodies
    https://pubmed.ncbi.nlm.nih.gov/34679458/
    LFIA anti-SARS-CoV-2 antibody tests, IgM and/or IgG, known as serology tests, are used for identification if a person has previously been exposed to the virus or vaccine immunization. […] Notably, advanced techniques, such as LFT-based CRISPR-Cas9 and surface-enhanced Raman spectroscopy (SERS), have added new dimensions to the COVID-19 diagnosis and are also discussed in this review.
  • #13 What tests could potentially be used for the screening, diagnosis and monitoring of COVID-19 and what are their advantages and disadvantages?  | The Centre for Evidence-Based Medicine
    https://www.cebm.net/covid-19/what-tests-could-potentially-be-used-for-the-screening-diagnosis-and-monitoring-of-covid-19-and-what-are-their-advantages-and-disadvantages/
    Lateral flow tests can detect antibody to virus from patient blood indicating that the patient has COVID-19 or has recovered from COVID-19. […] Antibody lateral flow tests for SARS-CoV-2 are produced as test kits used by a specialist or clinician rather than by patients themselves. […] Lateral flow immunoassays for SARS-CoV-2 detect two types of protective antibodies that are produced by the body when the immune system recognises a foreign structure, in this case SARS-CoV-2, the virus causing COVID-19. […] Antigen lateral flow immunoassays are an even newer technology with additional scientific and technical challenges which mean they are not likely to be developed during the pandemic period. […] ELISA tests to detect antibodies are detecting the antibody response to COVID-19 infection. Detecting antibodies to SARS-CoV-2 could tell a clinician if a patient has been infected with COVID-19, either currently or in the past.
  • #14 Evaluation of Commercial Rapid Lateral Flow Tests, Alone or in Combination, for SARS-CoV-2 Antibody Testing in: The American Journal of Tropical Medicine and Hygiene Volume 105 Issue 2 (2021)
    https://www.ajtmh.org/view/journals/tpmd/105/2/article-p378.xml
    Our study focused on the evaluation of rapid, point-of-care tests using lateral flow assay (LFA) technology that could be especially helpful for antibody testing in low- and middle-income countries. […] The primary objectives of the study were to assess the sensitivity and specificity of tests for antibodies to SARS-CoV-2 proteins, and the kinetics of antibody responses relative to the time of symptom onset. […] We evaluated six rapid-format, point-of-care LFA antibody test kits that detect both IgM and IgG antibodies to recombinant viral proteins. […] The sensitivity of the six LFAs and two laboratory-based tests varied by test and by time after the onset of COVID-19 symptoms. […] The sensitivity of the LFAs to detect IgM or IgG antibodies were between 18.8% and 40.6% 0 to 3 days after the onset of symptoms, and peaked between 80.3% and 96.4% more than 14 days after the onset of symptoms.
  • #15 Diagnostic performance of multiplex lateral flow tests in ambulatory patients with acute respiratory illness | medRxiv
    https://www.medrxiv.org/content/10.1101/2024.03.18.24304455v1.full-text
    We assessed the performance of three different multiplex lateral flow assays which provide results for influenza, respiratory syncytial virus (RSV) and SARS-CoV-2. […] The multiplex lateral flow tests provided timely diagnosis of influenza, RSV and SARS-CoV-2 infection and can be used to inform clinical management and infection control such as isolation behaviours. […] Lateral flow tests, also referred to as rapid antigen tests, are point of care devices that can identify the presence of an infectious disease by detecting microbial proteins within 30 minutes. […] The key advantage of lateral flow tests over the current gold standard, polymerase chain reaction (PCR) assay is the lower cost and the quick turnaround time for results. […] Additionally, performing PCR tests requires trained staff and laboratory infrastructure that is resource intensive and may not always be available.
  • #16 Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)-Healgen-Products and Services
    https://www.healgen.com/covid19-influenza-a-b
    Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 by their healthcare provider within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests. […] This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens. […] Results are for the in vitro detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus protein antigens, but do not differentiate, between SARS-CoV and SARS-CoV-2 viruses and are not intended to detect influenza C antigens.
  • #17 Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)-Healgen-Products and Services
    https://www.healgen.com/covid19-influenza-a-b
    Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 by their healthcare provider within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests. […] This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens. […] Results are for the in vitro detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus protein antigens, but do not differentiate, between SARS-CoV and SARS-CoV-2 viruses and are not intended to detect influenza C antigens.
  • #18 COVID Testing – COVID-19 Protocols
    https://covidprotocols.org/chapters/covid-testing/
    Rapid Antigen RDTs are an alternative to NAAT as screening tests where testing capacity is limited and the proportion of test positivity is high (10%). […] The minimum performance requirements for Ag-RDT set by the WHO are 80% sensitivity and 97% specificity compared to a NAAT reference assay. […] Antigen RDTs will be useful to implement a test and treat program (widespread screening, early detection of disease, and prompt initiation of appropriate treatment).
  • #19 COVID-19 rapid antigen test – Wikipedia
    https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test
    Although the specificity of RATs are high (98%-99%), in 2020 RATs were criticized for having a sensitivity as low as 50%; that is, if people with COVID-19 as determined by a positive PCR test were also tested with a RAT, about half the time the RAT would be negative. […] As of 2022, systematic reviews determined that the pooled sensitivities of RATs were 70%-72%. […] The sensitivity of the RAT was lower in persons who were vaccinated against COVID-19 than in persons who were not vaccinated against COVID-19. […] The sensitivity was higher for symptomatic people (76%-82%) than for asymptomatic people (57%-68%). […] The World Health Organization (WHO) recommends RATs with „≥ 80% sensitivity”, many RATs do not meet the WHO recommendation. […] In November 2020, a new, marginally more infectious strain of SARS-CoV-2 was identified in the United Kingdom, the SARS-CoV-2 Alpha variant.
  • #20 How accurate are rapid antigen tests for diagnosing COVID-19? | Cochrane
    https://www.cochrane.org/CD013705/INFECTN_how-accurate-are-rapid-antigen-tests-diagnosing-covid-19
    In people with confirmed COVID-19, antigen tests correctly identified COVID-19 infection in an average of 73% of people with symptoms, compared to 55% of people without symptoms. […] Tests were most accurate when used in the first week after symptoms began (an average of 82% of confirmed cases had positive antigen tests). […] For people with no symptoms, tests were most accurate in people likely to have been in contact with a case of COVID-19 infection (an average of 64% of confirmed cases had positive antigen tests). […] In people who did not have COVID-19, antigen tests correctly ruled out infection in 99.6% of people with symptoms and 99.7% of people without symptoms. […] Different brands of tests varied in accuracy. […] No test met this standard when evaluated in people without symptoms.
  • #21 How accurate are rapid antigen tests for diagnosing COVID-19? | Cochrane
    https://www.cochrane.org/CD013705/INFECTN_how-accurate-are-rapid-antigen-tests-diagnosing-covid-19
    In people with confirmed COVID-19, antigen tests correctly identified COVID-19 infection in an average of 73% of people with symptoms, compared to 55% of people without symptoms. […] Tests were most accurate when used in the first week after symptoms began (an average of 82% of confirmed cases had positive antigen tests). […] For people with no symptoms, tests were most accurate in people likely to have been in contact with a case of COVID-19 infection (an average of 64% of confirmed cases had positive antigen tests). […] In people who did not have COVID-19, antigen tests correctly ruled out infection in 99.6% of people with symptoms and 99.7% of people without symptoms. […] Different brands of tests varied in accuracy. […] No test met this standard when evaluated in people without symptoms.
  • #22 COVID-19 rapid antigen test – Wikipedia
    https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test
    Although the specificity of RATs are high (98%-99%), in 2020 RATs were criticized for having a sensitivity as low as 50%; that is, if people with COVID-19 as determined by a positive PCR test were also tested with a RAT, about half the time the RAT would be negative. […] As of 2022, systematic reviews determined that the pooled sensitivities of RATs were 70%-72%. […] The sensitivity of the RAT was lower in persons who were vaccinated against COVID-19 than in persons who were not vaccinated against COVID-19. […] The sensitivity was higher for symptomatic people (76%-82%) than for asymptomatic people (57%-68%). […] The World Health Organization (WHO) recommends RATs with „≥ 80% sensitivity”, many RATs do not meet the WHO recommendation. […] In November 2020, a new, marginally more infectious strain of SARS-CoV-2 was identified in the United Kingdom, the SARS-CoV-2 Alpha variant.
  • #23 IDSA Guidelines on the Diagnosis of COVID-19: Antigen Testing
    https://www.idsociety.org/practice-guideline/covid-19-guideline-antigen-testing/
    The overall quality of available evidence supporting use of Ag testing was graded as very low to moderate. […] The overall specificity of SARS-CoV-2 Ag tests was 99% compared to standard nucleic acid amplification testing (NAAT). […] A single Ag test has high specificity; a positive result can be used to guide treatment and isolation decisions without confirmation. […] For optimal performance, Ag tests should be performed within 5 days of symptom onset. […] The panel suggests using standard NAAT over Ag tests if standard NAAT is available and results of testing will be timely. […] The panel recognizes the value of diagnosing COVID-19 quickly, since treatment options are typically approved for administration within 5 days of symptom onset. […] A negative Ag test result reduces the likelihood of SARS-CoV-2 infection. However, the longer the time since testing, the more this likelihood reduction wanes, especially early in infection when virus replication may be rapid.
  • #24 How Do Rapid Antigen Tests Work? | Today’s Clinical Lab
    https://www.clinicallab.com/how-do-rapid-antigen-tests-work-26279
    If, after the instructed time has passed, any line is visible on the test line, the result is considered positive. The specificity of lateral flow tests is generally very high (meaning there is a small chance of false positive results). […] Unlike positive results, where you can be quite confident in the result, negative results don’t necessarily mean you are truly negative. With any of these tests, two major aspects influence the possibility of receiving a negative result: the way the sample was acquired and the timing of the infection. […] The biggest factor, though, is the timing of the sample. For COVID-19 tests, if the sample is taken too early (before symptoms are present), or too late (beyond the first week of symptoms), a negative result may occur. In other words, receiving a negative result doesn’t mean you are free of infection.
  • #25 SARS-CoV-2 antigen lateral flow tests for detecting infectious people: linked data analysis | The BMJ
    https://www.bmj.com/content/376/bmj-2021-066871
    Although empirical data show LFTs give a positive result when virus is present on a swab in high quantities, and therefore can detect people who are likely to be infectious, the proportion missed who are infectious has not been evaluated. […] The analysis predicted that of those with a viral culture positive result, Innova would miss 20% attending an NHS Test-and-Trace centre, 29% without symptoms attending municipal mass testing, and 81% attending university screen testing without symptoms, along with 38%, 47%, and 90% of sources of secondary cases. […] The sensitivity of Innova was predicted to be 95% at Ct values 14 (2.6107 viral copies/mL) but 50% at Ct values 22 (6.1104 viral copies/mL). […] The predicted proportion of infected people detectable by RT-PCR match closely with the observed sensitivity data from the three settings. […] The current analysis of these empirical data highlights inaccuracies in the assumptions made by key models about the relationships between viral loads and infectiousness, resulting in an overestimation of test sensitivity.
  • #26 COVID-19 rapid antigen test – Wikipedia
    https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test
    A study published in 2022 found that the sensitivities of six rapid antigen detection tests were 70.0%-92.9% for the Delta variant and 69.6%-78.3% for the Omicron variant across a range of viral loads; however, for Omicron samples with a low viral load, the sensitivities were 0.0%-23.1%. […] If a COVID-19 RAT is used outside manufacturer recommendations, the result can be false positive. […] Some have raised concerns about the slow deployment and uptake of RATs, and the potential loss of life that might have occurred as a result. […] Various concerns have been raised related to the safety of chemical components contained within RAT kits, which can be toxic to humans if not properly used. […] COVID-19 rapid antigen tests (RATs) detect antigenic proteins on the surface of or in the interior of the SARS-CoV-2 coronavirus. […] A typical COVID-19 RAT is a lateral flow test (LFT).
  • #27 How accurate are rapid antigen tests for diagnosing COVID-19? | Cochrane
    https://www.cochrane.org/CD013705/INFECTN_how-accurate-are-rapid-antigen-tests-diagnosing-covid-19
    In people with confirmed COVID-19, antigen tests correctly identified COVID-19 infection in an average of 73% of people with symptoms, compared to 55% of people without symptoms. […] Tests were most accurate when used in the first week after symptoms began (an average of 82% of confirmed cases had positive antigen tests). […] For people with no symptoms, tests were most accurate in people likely to have been in contact with a case of COVID-19 infection (an average of 64% of confirmed cases had positive antigen tests). […] In people who did not have COVID-19, antigen tests correctly ruled out infection in 99.6% of people with symptoms and 99.7% of people without symptoms. […] Different brands of tests varied in accuracy. […] No test met this standard when evaluated in people without symptoms.
  • #28 SARS-CoV-2 antigen lateral flow tests for detecting infectious people: linked data analysis | The BMJ
    https://www.bmj.com/content/376/bmj-2021-066871
    Although empirical data show LFTs give a positive result when virus is present on a swab in high quantities, and therefore can detect people who are likely to be infectious, the proportion missed who are infectious has not been evaluated. […] The analysis predicted that of those with a viral culture positive result, Innova would miss 20% attending an NHS Test-and-Trace centre, 29% without symptoms attending municipal mass testing, and 81% attending university screen testing without symptoms, along with 38%, 47%, and 90% of sources of secondary cases. […] The sensitivity of Innova was predicted to be 95% at Ct values 14 (2.6107 viral copies/mL) but 50% at Ct values 22 (6.1104 viral copies/mL). […] The predicted proportion of infected people detectable by RT-PCR match closely with the observed sensitivity data from the three settings. […] The current analysis of these empirical data highlights inaccuracies in the assumptions made by key models about the relationships between viral loads and infectiousness, resulting in an overestimation of test sensitivity.
  • #29 IDSA Guidelines on the Diagnosis of COVID-19: Antigen Testing
    https://www.idsociety.org/practice-guideline/covid-19-guideline-antigen-testing/
    The overall quality of available evidence supporting use of Ag testing was graded as very low to moderate. […] The overall specificity of SARS-CoV-2 Ag tests was 99% compared to standard nucleic acid amplification testing (NAAT). […] A single Ag test has high specificity; a positive result can be used to guide treatment and isolation decisions without confirmation. […] For optimal performance, Ag tests should be performed within 5 days of symptom onset. […] The panel suggests using standard NAAT over Ag tests if standard NAAT is available and results of testing will be timely. […] The panel recognizes the value of diagnosing COVID-19 quickly, since treatment options are typically approved for administration within 5 days of symptom onset. […] A negative Ag test result reduces the likelihood of SARS-CoV-2 infection. However, the longer the time since testing, the more this likelihood reduction wanes, especially early in infection when virus replication may be rapid.
  • #30 COVID-19 testing – NHS
    https://www.nhs.uk/conditions/covid-19-rapid-lateral-flow-test/
    A COVID-19 rapid lateral flow is a test you do yourself to check for COVID-19. They are available for free on the NHS to people who are eligible for COVID-19 treatment. […] A rapid lateral flow test is done to check if you have COVID-19. […] If you’re eligible for COVID-19 treatments, you’ll need to take a COVID-19 rapid lateral flow test if you have any symptoms of COVID-19. […] You can get free COVID-19 rapid lateral flow tests from a pharmacy if you’re eligible for COVID-19 treatments because you’re at highest risk of getting seriously ill from COVID-19. […] COVID-19 rapid lateral flow tests show the result on the testing device within a few minutes. […] If you get a positive COVID-19 rapid lateral flow test result, it means it’s very likely you have COVID-19. […] If you test positive for COVID-19, try to stay home and avoid meeting people for: 3 days after the day the test was taken if you’re under 18 years – children and young people tend to be infectious for less time than adults; 5 days after the day you took your test if you’re aged 18 or over. […] If you get a negative COVID-19 rapid lateral flow test result, it means it’s unlikely you have COVID-19. […] If you test negative and you’re eligible for COVID-19 treatments, you need to do a total of 3 rapid lateral flow tests over 3 days (1 test a day) if you continue to have COVID-19 symptoms.
  • #31 A guide to COVID-19 tests for the public
    https://www.rcpath.org/profession/coronavirus-resource-hub/guide-to-covid-19-tests-for-members-of-the-public.html
    The tests commonly available for SARS-CoV-2 can detect either: […] the surrounding proteins – detected by the rapid lateral flow devices. […] These are the rapid tests that are used in the community. They are convenient because they can give a result within 30 minutes and do not need a laboratory. […] They detect proteins from the virus, not RNA. […] These tests are very different from PCR. They are not suitable for diagnosing individual patients who suspect they may be infected because they have symptoms. […] Lateral flow tests are intended for picking up additional infected cases who would otherwise be missed because they don’t have any symptoms. […] These tests are not as sensitive as PCR. They are simply a convenient way of picking up a proportion of undiagnosed people who have no symptoms. […] If a person tests positive with these tests, they need to confirm this by having a more accurate PCR. […] A negative lateral flow test should not be used to rule out infection or indicate that it is safe to do something such as visit relatives.
  • #32 Lateral flow tests: Do LFTs detect the omicron coronavirus variant? | New ScientistFacebook / MetaTwitter / X iconLinkedinRedditEmail
    https://www.newscientist.com/article/2302118-how-reliable-are-covid-19-lateral-flow-tests-for-detecting-omicron/
    Are LFTs less good than PCRs? Rapid tests aren’t as good as PCR tests at detecting the coronavirus because PCR tests involve a step where the genetic material is multiplied over and over again, so they can detect tiny starting amounts. LFTs have no multiplying stage, so may miss infections where virus levels are low. […] Various studies have put the sensitivity of LFTs – in other words, their ability to detect the virus if it is there – at about 40 to 60 per cent. […] Taking this into account, modelling work by Petersen’s team suggests that a study in Liverpool that gave a sensitivity of 40 per cent for LFTs actually indicates that their accuracy is more than 80 per cent. […] If rapid LFTs are unreliable, what is the point of taking one? […] People should use a positive result as a “red light” for stopping a social activity, but they shouldn’t use a negative result as a “green light” to go ahead with an activity that is potentially risky, as they might have some mild covid-19 symptoms, she says.
  • #33 COVID-19 testing – NHS
    https://www.nhs.uk/conditions/covid-19-rapid-lateral-flow-test/
    A COVID-19 rapid lateral flow is a test you do yourself to check for COVID-19. They are available for free on the NHS to people who are eligible for COVID-19 treatment. […] A rapid lateral flow test is done to check if you have COVID-19. […] If you’re eligible for COVID-19 treatments, you’ll need to take a COVID-19 rapid lateral flow test if you have any symptoms of COVID-19. […] You can get free COVID-19 rapid lateral flow tests from a pharmacy if you’re eligible for COVID-19 treatments because you’re at highest risk of getting seriously ill from COVID-19. […] COVID-19 rapid lateral flow tests show the result on the testing device within a few minutes. […] If you get a positive COVID-19 rapid lateral flow test result, it means it’s very likely you have COVID-19. […] If you test positive for COVID-19, try to stay home and avoid meeting people for: 3 days after the day the test was taken if you’re under 18 years – children and young people tend to be infectious for less time than adults; 5 days after the day you took your test if you’re aged 18 or over. […] If you get a negative COVID-19 rapid lateral flow test result, it means it’s unlikely you have COVID-19. […] If you test negative and you’re eligible for COVID-19 treatments, you need to do a total of 3 rapid lateral flow tests over 3 days (1 test a day) if you continue to have COVID-19 symptoms.
  • #34 Lateral Flow Tests Effective at Detecting COVID-19 When Used at Symptom Onset | Today’s Clinical Lab
    https://www.clinicallab.com/lateral-flow-tests-effective-at-detecting-covid-19-when-used-at-symptom-onset-25806
    A new study by researchers at Queen Mary University of London, University of Oxford, Institute for Advanced Studies, Vienna, and the Medical University of Graz, has found that lateral flow tests detect COVID-19 with similar accuracy to laboratory-based PCR tests, providing they are used at the onset of infection and soon after symptoms start. […] The lateral flow tests detected more than 95 percent of the cases found by PCR, and correctly identified 89 percent of cases as negative. […] Our study is the first study to demonstrate that point-of-care antigen testing using lateral flow tests combined with clinical assessment of symptomatic patients can rapidly and accurately detect SARS-CoV-2 infection in primary care. […] In summary, this study provides evidence that lateral flow tests can accurately detect SARS-CoV-2 infection as an alternative to PCR testing among symptomatic patients in a real-life primary care setting across a large geographical area.
  • #35 How Accurate is Lateral Flow Rapid Testing for SARS-CoV-2? – The ObG Project
    https://www.obgproject.com/2021/08/05/how-accurate-is-lateral-flow-rapid-testing-for-sars-cov-2/
    SARS-CoV-2 antigen detection via lateral flow testing (LFT) is faster than RT-PCR and useful for population-wide testing. […] If rapid tests are accurate, patients could be managed based upon same-day test results. […] Lateral flow rapid testing is an accurate method for diagnosing SARS-CoV-2 infection, with a sensitivity of 95.4% and specificity of 89.1%. […] Symptomatic antigen testing for SARS-CoV-2 with LFT delivered at scale in a general clinical setting such as primary care as early as onset symptom, and when viral load is high and Ct-value is low, can rapidly and accurately detect early COVID-19 among patients presenting with flu-like illness.
  • #36 Diagnostic performance of multiplex lateral flow tests in ambulatory patients with acute respiratory illness | medRxiv
    https://www.medrxiv.org/content/10.1101/2024.03.18.24304455v1.full-text
    Lateral flow tests were widely distributed during the COVID-19 pandemic to improve diagnosis of cases in the community and facilitate more efficient isolation and quarantine policies. […] The objective of this study was to assess the performance of three different multiplex lateral flow tests for detecting SAR-CoV-2, influenza A/B and RSV compared to RT-PCR in an outpatient setting in Hong Kong. […] The sensitivity and specificity of each of the lateral flow tests was estimated using RT-PCR confirmed infection for each virus as the comparator. […] The estimated sensitivity of the three lateral flow tests increased as the viral load increased which is consistent with previous literature. […] The use of lateral flow tests has been more limited in healthcare settings where PCR is readily available. However, they can efficiently implement control measures and providing an accurate diagnosis will guide appropriate treatment.
  • #37 IDSA Guidelines on the Diagnosis of COVID-19: Antigen Testing
    https://www.idsociety.org/practice-guideline/covid-19-guideline-antigen-testing/
    The overall quality of available evidence supporting use of Ag testing was graded as very low to moderate. […] The overall specificity of SARS-CoV-2 Ag tests was 99% compared to standard nucleic acid amplification testing (NAAT). […] A single Ag test has high specificity; a positive result can be used to guide treatment and isolation decisions without confirmation. […] For optimal performance, Ag tests should be performed within 5 days of symptom onset. […] The panel suggests using standard NAAT over Ag tests if standard NAAT is available and results of testing will be timely. […] The panel recognizes the value of diagnosing COVID-19 quickly, since treatment options are typically approved for administration within 5 days of symptom onset. […] A negative Ag test result reduces the likelihood of SARS-CoV-2 infection. However, the longer the time since testing, the more this likelihood reduction wanes, especially early in infection when virus replication may be rapid.
  • #38
    https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays
    Direct detection of SARS-CoV-2 viral proteins (antigens) in nasal swabs and other respiratory secretions using lateral flow immunoassays (also known as rapid diagnostic tests, RDTs) offers a faster and less expensive method to test for SARS-CoV-2 than the reference method, nucleic acid amplification tests (NAATs). […] This interim guidance offers recommendations on the priority uses of antigen-detecting rapid diagnostic tests (Ag-RDTs) in specific populations and settings, including (i) for primary case detection in symptomatic individuals suspected to be infected and asymptomatic individuals at high risk of COVID-19, (ii) for contact tracing, (iii) during outbreak investigations and (iv) to monitor trends of disease incidence in communities. […] Ag-RDTs meeting minimum performance requirements can be used outside of clinical and laboratory settings, including in communities, by trained operators in accordance with instructions. […] This document updates the first interim guidance on the potential role of Ag-RDTs in the diagnosis of COVID-19 (Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays) released on 11 September 2020.
  • #39 Lateral Flow Tests Effective at Detecting COVID-19 When Used at Symptom Onset | Today’s Clinical Lab
    https://www.clinicallab.com/lateral-flow-tests-effective-at-detecting-covid-19-when-used-at-symptom-onset-25806
    A new study by researchers at Queen Mary University of London, University of Oxford, Institute for Advanced Studies, Vienna, and the Medical University of Graz, has found that lateral flow tests detect COVID-19 with similar accuracy to laboratory-based PCR tests, providing they are used at the onset of infection and soon after symptoms start. […] The lateral flow tests detected more than 95 percent of the cases found by PCR, and correctly identified 89 percent of cases as negative. […] Our study is the first study to demonstrate that point-of-care antigen testing using lateral flow tests combined with clinical assessment of symptomatic patients can rapidly and accurately detect SARS-CoV-2 infection in primary care. […] In summary, this study provides evidence that lateral flow tests can accurately detect SARS-CoV-2 infection as an alternative to PCR testing among symptomatic patients in a real-life primary care setting across a large geographical area.
  • #40 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner
    https://www.nature.com/articles/s44222-022-00007-3
    Despite wide use and acceptability, COVID-19 LFTs and the care pathways in which they are used have limitations, particularly in terms of false positives and false negatives. […] The WHO has established a target product profile for COVID-19 antigen LFTs for use in suspected COVID-19 cases and close contacts, highlighting the application of LFTs in areas where reference molecular testing is unavailable, or where molecular turnaround times obviate their utility. […] COVID-19 testing programmes have been implemented on a city scale (for example, the United Kingdom Liverpool Community testing pilot), and on a national scale (for example, nationwide testing in Slovakia). […] The simplicity of LFTs comes with technical limitations and usage trade-offs. Notably, they are less sensitive than PCR and rely on visual readout.
  • #41 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner
    https://www.nature.com/articles/s44222-022-00007-3
    Despite wide use and acceptability, COVID-19 LFTs and the care pathways in which they are used have limitations, particularly in terms of false positives and false negatives. […] The WHO has established a target product profile for COVID-19 antigen LFTs for use in suspected COVID-19 cases and close contacts, highlighting the application of LFTs in areas where reference molecular testing is unavailable, or where molecular turnaround times obviate their utility. […] COVID-19 testing programmes have been implemented on a city scale (for example, the United Kingdom Liverpool Community testing pilot), and on a national scale (for example, nationwide testing in Slovakia). […] The simplicity of LFTs comes with technical limitations and usage trade-offs. Notably, they are less sensitive than PCR and rely on visual readout.
  • #42 Test performance of lateral flow rapid antigen tests for COVID-19 in Welsh adult care home staff using routine surveillance data | PLOS One
    https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0290406
    Lateral flow tests (LFTs) have been used to screen for SARS-CoV2 in Wales since January 2021. […] We estimated test performance of LFTs conducted in adult care home staff using PCR tests as a reference standard. […] Test result agreement was 99.59% (95%CI 99.55–99.63; MCC: 0.38, p<0.001). Sensitivity and specificity were 25.65% (95%CI 22.02–29.67) and 99.91% (95%CI 99.89–99.93), respectively. [...] Specificity and negative predictive value were high in an asymptomatic population of care home staff indicating this test is an effective tool for identifying cases of SARS-CoV-2 infection during periods of high prevalence where transmission is likely, due to the presence of high viral loads. [...] Positive predictive value results are lower than existing literature yet should be considered in light of the asymptomatic study population and low prevalence (under 1%) at the time most of these tests were conducted.
  • #43 Lateral flow test – Wikipedia
    https://en.wikipedia.org/wiki/Lateral_flow_test
    Lateral flow assays have played a critical role in COVID-19 testing as they have the benefit of delivering a result in 15–30 minutes. […] A study that started in June 2020 in the United Kingdom, FALCON-C19, confirmed the sensitivity of some lateral flow devices (LFDs) in this setting. […] Four out of 64 LFDs tested had desirable performance characteristics according to these early tests; the Innova SARS-CoV-2 Antigen Rapid Qualitative Test performed moderately in viral antigen detection/sensitivity with excellent specificity, although kit failure rates and the impact of training were potential issues. […] After closure of schools in January 2021, biweekly LFTs were introduced in England for teachers, pupils, and households of pupils when schools re-opened on March 8, 2021 for asymptomatic testing.
  • #44
    https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays
    Direct detection of SARS-CoV-2 viral proteins (antigens) in nasal swabs and other respiratory secretions using lateral flow immunoassays (also known as rapid diagnostic tests, RDTs) offers a faster and less expensive method to test for SARS-CoV-2 than the reference method, nucleic acid amplification tests (NAATs). […] This interim guidance offers recommendations on the priority uses of antigen-detecting rapid diagnostic tests (Ag-RDTs) in specific populations and settings, including (i) for primary case detection in symptomatic individuals suspected to be infected and asymptomatic individuals at high risk of COVID-19, (ii) for contact tracing, (iii) during outbreak investigations and (iv) to monitor trends of disease incidence in communities. […] Ag-RDTs meeting minimum performance requirements can be used outside of clinical and laboratory settings, including in communities, by trained operators in accordance with instructions. […] This document updates the first interim guidance on the potential role of Ag-RDTs in the diagnosis of COVID-19 (Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays) released on 11 September 2020.
  • #45
    https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays
    Direct detection of SARS-CoV-2 viral proteins (antigens) in nasal swabs and other respiratory secretions using lateral flow immunoassays (also known as rapid diagnostic tests, RDTs) offers a faster and less expensive method to test for SARS-CoV-2 than the reference method, nucleic acid amplification tests (NAATs). […] This interim guidance offers recommendations on the priority uses of antigen-detecting rapid diagnostic tests (Ag-RDTs) in specific populations and settings, including (i) for primary case detection in symptomatic individuals suspected to be infected and asymptomatic individuals at high risk of COVID-19, (ii) for contact tracing, (iii) during outbreak investigations and (iv) to monitor trends of disease incidence in communities. […] Ag-RDTs meeting minimum performance requirements can be used outside of clinical and laboratory settings, including in communities, by trained operators in accordance with instructions. […] This document updates the first interim guidance on the potential role of Ag-RDTs in the diagnosis of COVID-19 (Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays) released on 11 September 2020.
  • #46 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner
    https://www.nature.com/articles/s44222-022-00007-3
    The viral load threshold for transmission has been proposed to be about 1,000,000 copies, and therefore, rapid antigen tests are considered to be a good public health tool with which to identify infectious people and those at risk of transmitting SARS-CoV-2 to others, thus reducing community transmission. […] In many high-income regions, COVID-19 self-tests have been widely available since 2021, often subsidized or free to the public through pharmacies or online ordering. […] The COVID-19 pandemic has revealed enormous inequities in access to tests, vaccines and therapeutics. […] The COVID-19 pandemic has reduced public access to care, and antimicrobial prescribing and childhood immunizations have decreased. […] The COVID-19 pandemic has affected the approach of regulators with regard to approving lateral flow tests (LFTs), including early engagement with and guidance to test developers.
  • #47 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner
    https://www.nature.com/articles/s44222-022-00007-3
    The viral load threshold for transmission has been proposed to be about 1,000,000 copies, and therefore, rapid antigen tests are considered to be a good public health tool with which to identify infectious people and those at risk of transmitting SARS-CoV-2 to others, thus reducing community transmission. […] In many high-income regions, COVID-19 self-tests have been widely available since 2021, often subsidized or free to the public through pharmacies or online ordering. […] The COVID-19 pandemic has revealed enormous inequities in access to tests, vaccines and therapeutics. […] The COVID-19 pandemic has reduced public access to care, and antimicrobial prescribing and childhood immunizations have decreased. […] The COVID-19 pandemic has affected the approach of regulators with regard to approving lateral flow tests (LFTs), including early engagement with and guidance to test developers.
  • #48
    https://ihealthlabs.com/pages/ihealth-covid-19-antigen-rapid-test-details?srsltid=AfmBOorS5qdmZdMr3wTmBTOc1rFFbX2EcKSi4Aibd8ZoOH7_mdeG1BPv
    The iHealth COVID-19 Antigen Rapid Test is able to detect small parts of the SARS-CoV-2 virus, known as N protein or antigens, in your nasal secretions. […] The iHealth COVID-19 Antigen Rapid Test has been designed to minimize the likelihood of false positive test results. […] A positive test result for COVID-19 indicates that antigens from SARS-CoV-2 were detected, and the patient is very likely to be infected with the virus and presumed to be contagious. […] A negative test result for this test means that antigens from SARS-CoV-2 were not present in the specimen above the limit of detection. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. […] This test is authorized for nonprescription home use with self-collected (unobserved) anterior nasal swab specimens from individuals aged 15 years and older or with adult-collected anterior nasal swab samples from individuals aged 2 years or older.
  • #49 Azthena logo with the word Azthena
    https://www.news-medical.net/news/20230123/Review-on-lateral-flow-test-use-spearheaded-by-SARS-CoV-2-pandemic.aspx
    However, LFTs were used successfully during COVID-19 due to the high SARS-CoV-2 transmissibility and short incubation periods to assess the infectiousness or transmission risks of SARS-CoV-2. […] Major roadblocks in LFT development and use include the lack of accessibility to well-characterized samples for testing and validation, low sensitivity, limited digital connectivity, scarce cost-efficacy evidence, delays in regulatory processes, and centralized manufacture of materials. […] Observations from the pandemic have shown that LFT self-testing at a large scale could offer several benefits, such as early identification and prompt self-isolation, increased accessibility to diagnostic tests, increased frequency of testing, increased compliance with public health measures, curtailed viral transmission, and facilitated early recovery.
  • #50 Azthena logo with the word Azthena
    https://www.news-medical.net/news/20230123/Review-on-lateral-flow-test-use-spearheaded-by-SARS-CoV-2-pandemic.aspx
    However, LFTs were used successfully during COVID-19 due to the high SARS-CoV-2 transmissibility and short incubation periods to assess the infectiousness or transmission risks of SARS-CoV-2. […] Major roadblocks in LFT development and use include the lack of accessibility to well-characterized samples for testing and validation, low sensitivity, limited digital connectivity, scarce cost-efficacy evidence, delays in regulatory processes, and centralized manufacture of materials. […] Observations from the pandemic have shown that LFT self-testing at a large scale could offer several benefits, such as early identification and prompt self-isolation, increased accessibility to diagnostic tests, increased frequency of testing, increased compliance with public health measures, curtailed viral transmission, and facilitated early recovery.
  • #51 Azthena logo with the word Azthena
    https://www.news-medical.net/news/20230123/Review-on-lateral-flow-test-use-spearheaded-by-SARS-CoV-2-pandemic.aspx
    However, LFTs were used successfully during COVID-19 due to the high SARS-CoV-2 transmissibility and short incubation periods to assess the infectiousness or transmission risks of SARS-CoV-2. […] Major roadblocks in LFT development and use include the lack of accessibility to well-characterized samples for testing and validation, low sensitivity, limited digital connectivity, scarce cost-efficacy evidence, delays in regulatory processes, and centralized manufacture of materials. […] Observations from the pandemic have shown that LFT self-testing at a large scale could offer several benefits, such as early identification and prompt self-isolation, increased accessibility to diagnostic tests, increased frequency of testing, increased compliance with public health measures, curtailed viral transmission, and facilitated early recovery.
  • #52 Over-the-Counter Rapid COVID-19 Testing, in your Hands | Abbott Newsroom
    https://www.abbott.com/corpnewsroom/diagnostics-testing/over-the-counter-rapid-COVID-19-testing-in-your-hands.html
    The test for is for self-use when people test themselves twice within three days, with 36 hours between the two tests. […] Our trusted, affordable, easy-to-use 15-minute test can now detect COVID-19 in both symptomatic and asymptomatic people in your own home, on your own time, with none of the inconveniences and high prices of COVID tests’ past. […] The authorization of our BinaxNOW Self Test will remove the remaining barriers that may have prevented the masses from accessing tests while permitting serial (frequent) testing for asymptomatic people, helping society collectively return to daily life. […] While vaccines are rolling out, not all of us are able to receive them as soon as we’d like. […] The BinaxNOW COVID-19 Antigen Self Test has not been FDA cleared or approved. […] It has been authorized by the FDA under an emergency use authorization.
  • #53 COVID-19 Test (QuickVue) | QuidelOrtho
    https://www.quidelortho.com/global/en/consumers/quickvue-otc
    The QuickVue COVID-19 Test provides swift results conveniently within your home. With all necessary components included in the over-the-counter package, conducting the test is straightforward and hassle-free. […] The QuickVue COVID-19 Test is fast, simple and designed to be used in the comfort of your home. This easy-to-use test requires a nasal swab sample to determine a positive or negative result for COVID-19. The testing procedure is simple and fast, swirl the swab in a tube of reagent solution, then remove it. Next, insert a test strip into the solution. After 10 minutes, remove the test strip from the tube to confirm the results. It is best practice to read the instructions prior to starting the test as it is important to follow the instructions to ensure an accurate result. […] Our QuickVue At-Home OTC COVID-19 Test has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) under the new name – QuickVue COVID-19 Test. The QuickVue COVID-19 Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal (nares) swab specimens from individuals with signs and symptoms of COVID-19 within the first 5 days from symptom onset. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older. The QuickVue COVID-19 Test does not differentiate between SARS-CoV and SARS-CoV-2. All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment. Positive results do not rule out co-infection with other respiratory pathogens. This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider. The performance characteristics for SARS-CoV-2 were established from January 2021 to February 2024 when COVID-19 variants Alpha, Delta, and Omicron were dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.
  • #54 Over-the-Counter Rapid COVID-19 Testing, in your Hands | Abbott Newsroom
    https://www.abbott.com/corpnewsroom/diagnostics-testing/over-the-counter-rapid-COVID-19-testing-in-your-hands.html
    BinaxNOW Ag is now available over-the-counter, bringing accessible COVID-19 rapid self-testing to the masses. […] Our BinaxNOW COVID-19 Self Test is now available at CVS Pharmacy, Walgreens and Walmart starting this week and will be rolled out nationwide in the next two weeks. […] A rapid antigen self-test to detect both asymptomatic and symptomatic COVID-19. […] Identical to our existing professional test that has been used nationwide since August 2020, bringing proven performance to the shelves. […] The BinaxNOW Self Test will initially be available at CVS Pharmacy, Walgreens and Walmart both online and in-stores. […] It is available over the counter and does not require a prescription. […] The self-test is indicated for children as young as 2 years old when samples are collected by an adult, and for all people 15 and older.
  • #55 COVID-19 Test (QuickVue) | QuidelOrtho
    https://www.quidelortho.com/global/en/consumers/quickvue-otc
    The QuickVue COVID-19 Test provides swift results conveniently within your home. With all necessary components included in the over-the-counter package, conducting the test is straightforward and hassle-free. […] The QuickVue COVID-19 Test is fast, simple and designed to be used in the comfort of your home. This easy-to-use test requires a nasal swab sample to determine a positive or negative result for COVID-19. The testing procedure is simple and fast, swirl the swab in a tube of reagent solution, then remove it. Next, insert a test strip into the solution. After 10 minutes, remove the test strip from the tube to confirm the results. It is best practice to read the instructions prior to starting the test as it is important to follow the instructions to ensure an accurate result. […] Our QuickVue At-Home OTC COVID-19 Test has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) under the new name – QuickVue COVID-19 Test. The QuickVue COVID-19 Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal (nares) swab specimens from individuals with signs and symptoms of COVID-19 within the first 5 days from symptom onset. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older. The QuickVue COVID-19 Test does not differentiate between SARS-CoV and SARS-CoV-2. All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment. Positive results do not rule out co-infection with other respiratory pathogens. This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider. The performance characteristics for SARS-CoV-2 were established from January 2021 to February 2024 when COVID-19 variants Alpha, Delta, and Omicron were dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.
  • #56 Frontiers | Recent Progress on Rapid Lateral Flow Assay-Based Early Diagnosis of COVID-19
    https://www.frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2022.866368/full
    Recent Progress on Rapid Lateral Flow Assay-Based Early Diagnosis of COVID-19 […] The outbreak of the coronavirus disease 2019 (COVID-19) has resulted in enormous losses worldwide. […] Therefore, it is necessary to develop a simple, convenient, and rapid detection strategy for controlling disease recurrence and transmission. Taking advantage of their low-cost and simple operation, point-of-care test (POCT) kits for COVID-19 based on the lateral flow assay (LFA) chemistry have become one of the most convenient and widely used screening tools for pathogens in hospitals and at home. […] A systematic comparison was realized through summarization and analyses, providing a comprehensive demonstration of the LFA technology and insights into preventing and curbing the COVID-19 pandemic. […] One of the most effective methods to control the pandemic is to develop rapid detection techniques to screen and diagnose infected individuals, including asymptomatic carriers, as soon as possible during the incubation period. […] Since the outbreak, researchers worldwide have developed numerous rapid and sensitive diagnostic kits that can be divided into two categories: genetic material-based molecular diagnosis and antigen/antibody-based immunoassays. […] The LFA technique for the early diagnosis has great potential for preventing, monitoring, and controlling COVID-19, especially in the post-pandemic era.
  • #57 COVID-19 testing using lateral flow assays: sensitive, rapid, easy to use and point-of-care
    https://www.selectscience.net/article/covid-19-testing-using-lateral-flow-assays-sensitive-rapid-easy-to-use-and-point-of-care
    “Lateral flow tests are cost-effective,” says O’Brien. “They’re cheap to manufacture at a large scale. They are also simple to use, offer results rapidly, and are portable.” […] “Using lateral flow testing, you can get results in less than 10 minutes.” Speedy testing of analytes is particularly useful for time-sensitive infection profiles as seen with the novel coronavirus or when there is a significant backlog or high demand for testing. […] Given its clear benefits compared to other immunoassay methods, the research team at Merck KGaA, Darmstadt, Germany is currently providing the ingredients to develop lateral flow assays to improve COVID-19 detection using both serological and antigen-based approaches. […] “RT-PCR only determines active infections,” says Hannigan. “So, it can’t detect whether a person has had the disease. Lateral flow-based antibody or serological tests, however, can diagnose different stages of the COVID-19 infection.”
  • #58 Wondfo 2019-nCoV Antigen Test
    https://en.wondfo.com/pt/index81.html
    2019-nCoV Antigen Test (Lateral Flow Method) […] The detection of antigen indicates the active infection. Under the circumstance that the area(s) still undergo widespread community transmission with limited RT-PCR resources, antigen can be used for aiding in the diagnosis of COVID-19 suspected patients. […] Fast […] Instant results within 15 minutes […] Lower cost, no equipment required and simpler operation make antigen test ideal for point-of-care settings […] Detect the virus directly, allowing the early detection of COVID-19 […] Non-invasive sampling: Antigen Test: swabs; Antibody Test: blood.
  • #59 The Emergence of Lateral Flow Assays in Diagnostics
    https://www.rapidmicrobiology.com/news/the-emergence-of-lateral-flow-assays-in-diagnostics
    How has the COVID-19 crisis changed our thinking about LFAs? Before the COVID-19 pandemic, the pregnancy test was the most prominent rapid test on the market. The SARS-COV-2 virus has changed that tremendously. The virus spread rapidly, making it necessary to produce a reliable and cheap tool to detect the virus at home. […] The tool of choice was a well-established and well-known lateral flow assay (LFA) method. Big manufacturers had existing platforms that they could use, so the first Over-the-Counter Covid-19 rapid antigen tests were available in Autumn 2020. Since then, awareness of LFA has increased worldwide. […] Fast and reliable results […] Cheap compared to laboratory diagnostics […] Readily available in drugstores and pharmacies […] Easy to use as no special training is required […] Can be used anywhere.
  • #60 The Emergence of Lateral Flow Assays in Diagnostics
    https://www.rapidmicrobiology.com/news/the-emergence-of-lateral-flow-assays-in-diagnostics
    How has the COVID-19 crisis changed our thinking about LFAs? Before the COVID-19 pandemic, the pregnancy test was the most prominent rapid test on the market. The SARS-COV-2 virus has changed that tremendously. The virus spread rapidly, making it necessary to produce a reliable and cheap tool to detect the virus at home. […] The tool of choice was a well-established and well-known lateral flow assay (LFA) method. Big manufacturers had existing platforms that they could use, so the first Over-the-Counter Covid-19 rapid antigen tests were available in Autumn 2020. Since then, awareness of LFA has increased worldwide. […] Fast and reliable results […] Cheap compared to laboratory diagnostics […] Readily available in drugstores and pharmacies […] Easy to use as no special training is required […] Can be used anywhere.
  • #61 How accurate are rapid antigen tests for diagnosing COVID-19? | Cochrane
    https://www.cochrane.org/CD013705/INFECTN_how-accurate-are-rapid-antigen-tests-diagnosing-covid-19
    In people with confirmed COVID-19, antigen tests correctly identified COVID-19 infection in an average of 73% of people with symptoms, compared to 55% of people without symptoms. […] Tests were most accurate when used in the first week after symptoms began (an average of 82% of confirmed cases had positive antigen tests). […] For people with no symptoms, tests were most accurate in people likely to have been in contact with a case of COVID-19 infection (an average of 64% of confirmed cases had positive antigen tests). […] In people who did not have COVID-19, antigen tests correctly ruled out infection in 99.6% of people with symptoms and 99.7% of people without symptoms. […] Different brands of tests varied in accuracy. […] No test met this standard when evaluated in people without symptoms.
  • #62 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner
    https://www.nature.com/articles/s44222-022-00007-3
    The viral load threshold for transmission has been proposed to be about 1,000,000 copies, and therefore, rapid antigen tests are considered to be a good public health tool with which to identify infectious people and those at risk of transmitting SARS-CoV-2 to others, thus reducing community transmission. […] In many high-income regions, COVID-19 self-tests have been widely available since 2021, often subsidized or free to the public through pharmacies or online ordering. […] The COVID-19 pandemic has revealed enormous inequities in access to tests, vaccines and therapeutics. […] The COVID-19 pandemic has reduced public access to care, and antimicrobial prescribing and childhood immunizations have decreased. […] The COVID-19 pandemic has affected the approach of regulators with regard to approving lateral flow tests (LFTs), including early engagement with and guidance to test developers.
  • #63 Point-of-care COVID-19 diagnostics powered by lateral flow assay – PMC Lock
    https://pmc.ncbi.nlm.nih.gov/articles/PMC8487324/
    In most countries, real-time reverse transcriptase quantitative polymerase chain reaction (rRT-qPCR), which detects SARS-CoV-2 RNA, is used as the gold standard for COVID-19 diagnosis. However, obtaining the test results of rRT-qPCR is time consuming (>24 h). In addition, rRT-qPCR requires specialized equipment, certified molecular testing laboratories with biosafety level 3, and skilled technicians and has a high false-negative rate of up to 30%. Therefore, a suitable detection system that can be used for SARS-CoV-2 detection at the point of care (POC) is important for the prevention and control of the COVID-19 pandemic. […] As a complement to the current rRT-qPCR assay, LFA-based rapid diagnostic tests have recently attracted extensive attention in curbing the spread and resurgence of COVID-19 since they can quickly identify new COVID-19 infections by analyzing specific biomarkers of SARS-CoV-2, such as nucleic acids, antibodies and antigens. Currently, numerous rapid diagnostic technologies based on LFA have been developed, part of which have been developed as rapid test kits for detecting SARS-CoV-2 and have played a big role in managing the COVID-19, especially in resource-limited settings with the low accessibility of rRT-qPCR assay.
  • #64 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner
    https://www.nature.com/articles/s44222-022-00007-3
    Lateral flow tests (LFTs) were adopted at an unprecedented scale during the COVID-19 pandemic, enabling access to testing beyond healthcare settings. […] The acceptability and feasibility of large-scale testing with lateral flow tests (LFTs) for clinical and public health purposes has been demonstrated during the COVID-19 pandemic. […] Key barriers to COVID-19 LFT development and adoption include lack of access to well characterized samples, limited accuracy, lack of connectivity, lack of evidence of cost-effectiveness, regulatory delays and centralized manufacturing capabilities. […] LFTs could also play an important part in the detection of other diseases of epidemic potential and antimicrobial resistance. […] The accuracy and, in particular, the sensitivity of LFTs is lower than that of reference RT-PCR methods, ranging between 34.1% and 88.1% for SARS-CoV-2 antigen LFTs, with an overall specificity of 99.6%.
  • #65 How accurate are rapid antigen tests for diagnosing COVID-19? | Cochrane
    https://www.cochrane.org/CD013705/INFECTN_how-accurate-are-rapid-antigen-tests-diagnosing-covid-19
    In people with symptoms, some rapid antigen tests are accurate enough to replace RT-PCR, especially for ruling in the presence of infection. […] Rapid antigen tests are less good at ruling out infection in symptomatic people – individuals who receive a negative rapid antigen test result may still be infected. […] Rapid antigen tests are less accurate when used in people with no symptoms of COVID-19. […] More evidence is needed to understand the accuracy of rapid testing in people without symptoms and the extent to which repeated testing strategies can lead to reduced transmission. […] Many commercially available rapid antigen tests have not been evaluated in independent validation studies. […] The variable sensitivity of antigen tests means that people who test negative may still be infected.
  • #66 SARS-CoV-2 antigen lateral flow tests for detecting infectious people: linked data analysis | The BMJ
    https://www.bmj.com/content/376/bmj-2021-066871
    Objectives To investigate the proportion of lateral flow tests (LFTs) that produce negative results in those with a high risk of infectiousness from SARS-CoV-2, to investigate the impact of the stage and severity of disease, and to compare predictions made by influential mathematical models with findings of empirical studies. […] The proportion of infectious people with SARS-CoV-2 missed by LFTs is substantial enough to be of clinical importance. The proportion missed varied between settings because of different viral load distributions and is likely to be highest in those without symptoms. Key models have substantially overestimated the sensitivity of LFTs compared with empirical data. An urgent need exists for additional robust well designed and reported empirical studies from intended use settings to inform evidence based policy.
  • #67 IDSA Guidelines on the Diagnosis of COVID-19: Antigen Testing
    https://www.idsociety.org/practice-guideline/covid-19-guideline-antigen-testing/
    The overall quality of available evidence supporting use of Ag testing was graded as very low to moderate. […] The overall specificity of SARS-CoV-2 Ag tests was 99% compared to standard nucleic acid amplification testing (NAAT). […] A single Ag test has high specificity; a positive result can be used to guide treatment and isolation decisions without confirmation. […] For optimal performance, Ag tests should be performed within 5 days of symptom onset. […] The panel suggests using standard NAAT over Ag tests if standard NAAT is available and results of testing will be timely. […] The panel recognizes the value of diagnosing COVID-19 quickly, since treatment options are typically approved for administration within 5 days of symptom onset. […] A negative Ag test result reduces the likelihood of SARS-CoV-2 infection. However, the longer the time since testing, the more this likelihood reduction wanes, especially early in infection when virus replication may be rapid.
  • #68 Rapidly adaptable automated interpretation of point-of-care COVID-19 diagnostics | Communications MedicineClose bannerClose banner
    https://www.nature.com/articles/s43856-023-00312-x
    It can be difficult to correctly interpret the results of rapid diagnostic tests that give a visual readout, such as COVID rapid tests. […] This algorithm can easily be adapted for use on results from different test kits. […] The algorithm was accurate at interpreting results obtained by members of the public using various COVID rapid tests and diagnostic tests with similar outputs used for other infections. […] The use of this algorithm should enable accurate interpretation of rapid diagnostic tests by members of the public and hence enable improved medical care. […] Errors in these steps hinder their deployment in primary care clinics and homes in challenging cases, especially those involving assays with absent control bands, failure to recognize faint bands, or inability to identify control vs. test bands.
  • #69 COVID-19 rapid antigen test – Wikipedia
    https://en.wikipedia.org/wiki/COVID-19_rapid_antigen_test
    A study published in 2022 found that the sensitivities of six rapid antigen detection tests were 70.0%-92.9% for the Delta variant and 69.6%-78.3% for the Omicron variant across a range of viral loads; however, for Omicron samples with a low viral load, the sensitivities were 0.0%-23.1%. […] If a COVID-19 RAT is used outside manufacturer recommendations, the result can be false positive. […] Some have raised concerns about the slow deployment and uptake of RATs, and the potential loss of life that might have occurred as a result. […] Various concerns have been raised related to the safety of chemical components contained within RAT kits, which can be toxic to humans if not properly used. […] COVID-19 rapid antigen tests (RATs) detect antigenic proteins on the surface of or in the interior of the SARS-CoV-2 coronavirus. […] A typical COVID-19 RAT is a lateral flow test (LFT).
  • #70 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner
    https://www.nature.com/articles/s44222-022-00007-3
    Lateral flow tests (LFTs) were adopted at an unprecedented scale during the COVID-19 pandemic, enabling access to testing beyond healthcare settings. […] The acceptability and feasibility of large-scale testing with lateral flow tests (LFTs) for clinical and public health purposes has been demonstrated during the COVID-19 pandemic. […] Key barriers to COVID-19 LFT development and adoption include lack of access to well characterized samples, limited accuracy, lack of connectivity, lack of evidence of cost-effectiveness, regulatory delays and centralized manufacturing capabilities. […] LFTs could also play an important part in the detection of other diseases of epidemic potential and antimicrobial resistance. […] The accuracy and, in particular, the sensitivity of LFTs is lower than that of reference RT-PCR methods, ranging between 34.1% and 88.1% for SARS-CoV-2 antigen LFTs, with an overall specificity of 99.6%.
  • #71 How accurate are rapid antigen tests for diagnosing COVID-19? | Cochrane
    https://www.cochrane.org/CD013705/INFECTN_how-accurate-are-rapid-antigen-tests-diagnosing-covid-19
    In people with symptoms, some rapid antigen tests are accurate enough to replace RT-PCR, especially for ruling in the presence of infection. […] Rapid antigen tests are less good at ruling out infection in symptomatic people – individuals who receive a negative rapid antigen test result may still be infected. […] Rapid antigen tests are less accurate when used in people with no symptoms of COVID-19. […] More evidence is needed to understand the accuracy of rapid testing in people without symptoms and the extent to which repeated testing strategies can lead to reduced transmission. […] Many commercially available rapid antigen tests have not been evaluated in independent validation studies. […] The variable sensitivity of antigen tests means that people who test negative may still be infected.
  • #72 Lateral flow technology scale up strengthens pandemic preparedness
    https://www.selectscience.net/article/lateral-flow-technology-scale-up-strengthens-pandemic-preparedness
    The COVID-19 pandemic has significantly transformed the landscape of diagnostic testing, emphasizing the critical need for rapid, accurate, and accessible point-of-care solutions. Among the technologies that have seen a surge in demand and innovation is lateral flow technology. Now, as the world braces for potential future pandemics, the role of lateral flow assays is expected to expand. […] The COVID-19 pandemic brought unprecedented attention to lateral flow technology, primarily due to the need for a rapid diagnostic test to help monitor and control the spread in populations. […] „The pandemic dramatically increased the demand for rapid, point-of-care testing and has spurred a massive surge in their development and production,” Katie Spitere, Product Portfolio Manager at Merck. […] „In the coming years, industry experts predict an increase in digitalization and the use of lateral flow readers to enable quantitative analysis of the test result,” Spitere adds.
  • #73 Rapidly adaptable automated interpretation of point-of-care COVID-19 diagnostics | Communications MedicineClose bannerClose banner
    https://www.nature.com/articles/s43856-023-00312-x
    Rapidly adaptable automated interpretation of point-of-care COVID-19 diagnostics […] Point-of-care diagnostic devices, such as lateral-flow assays, are becoming widely used by the public. […] We developed a software architecture called AutoAdapt POC that integrates automated membrane extraction, self-supervised learning, and few-shot learning to automate the interpretation of POC diagnostic tests using smartphone cameras in a scalable manner. […] Here we show AutoAdapt POC to yield 99% to 100% accuracy over 726 tests (350 positive, 376 negative). […] In a COVID-19 drive-through study with 74 untrained users self-testing, 98% found image collection easy, and the rapidly adapted models achieved classification accuracies of 100% on both COVID-19 antigen and antibody test kits. […] The study demonstrates how rapid domain adaptation in machine learning can provide quality assurance, linkage to care, and public health tracking for untrained users across diverse POC diagnostic tests.
  • #74 Frontiers | COVID-19 lateral flow test image classification using deep CNN and StyleGAN2
    https://www.frontiersin.org/journals/artificial-intelligence/articles/10.3389/frai.2023.1235204/full
    COVID-19 diagnosis primarily involves PCR or rapid antigen/lateral flow tests using nasopharyngeal or oropharyngeal swabs (Wang W. et al., 2020). […] Rapid antigen tests provide results in 10–20 min and are effective in COVID-19 detection (Dinnes et al., 2021). […] This research introduces an automated RATD validation system using deep convolutional neural network (CNN) for result interpretation in uncontrolled environments (Yamashita et al., 2018). […] The findings of this study highlight the potential of the developed model in expediting COVID-19 testing processes and facilitating large-scale testing and tracking systems. […] The proposed system utilizes deep CNN models to classify RATD images as either negative or positive cases. […] The proposed model leverages powerful CNN generative models like StyleGAN2-ADA, expanding the training image pool, enhancing generalization, and improving accuracy.
  • #75 Recent Advances in Quantum Dot-Based Lateral Flow Immunoassays for the Rapid, Point-of-Care Diagnosis of COVID-19
    https://www.mdpi.com/2079-6374/13/8/786
    The LFIA stands out as an appealing detection tool that possesses all the necessary qualities for effective colorimetric assays. […] The traditional LFIA method offers qualitative or semi-quantitative outcomes through a straightforward process that relies on color visualization, eliminating the need for additional equipment. […] One of the key advantages of the LFIA is its accessibility and convenience, as it does not necessitate well-equipped laboratories or extensively trained personnel to perform the tests. […] The QD-based LFIA stands as a highly promising and innovative point-of-care testing method for the detection of COVID-19. […] The QD-based LFIA exhibits excellent specificity during COVID-19 detection. […] The performance of quantum dot-based lateral flow immunoassays (QD-based LFIA) has emerged as a promising point-of-care testing method for detecting COVID-19, offering several notable advantages in the battle against the pandemic.
  • #76 Point-of-care COVID-19 diagnostics powered by lateral flow assay – PMC Lock
    https://pmc.ncbi.nlm.nih.gov/articles/PMC8487324/
    The ability of LFA to sense nucleic acids in a rapid and portable format has important applications ranging from field detection to clinical diagnostics. However, the SARS-CoV-2 concentration in specimen is very low and hard to be directly detected using LFA. Therefore, the integration of nucleic acid amplification technologies, such as RT-PCR, isothermal amplification, and clustered regularly interspaced short palindromic repeats (CRISPR), with LFA is a promising strategy to simplify the traditional molecular test, wherein LFA can allow the direct visual interpretation of nucleic acid amplification results. Given their considerable advantages of portability, rapidity, cost effectiveness, and user friendliness, advanced nucleic acid amplification-assisted LFA techniques for detecting viral RNA against SARS-CoV-2 have been developed recently.
  • #77 COVID-19 rapid test using CRISPR & HybriDetect
    https://www.milenia-biotec.com/en/covid-19-rapid-test-development/
    Due to these reasons, several groups are working on alternative tests for the quick, easy and low cost detection of SARS-CoV-2 with very little equipment needed. […] The so-called STOP (SHERLOCK Testing in One Pot) method is an improvement of the previous SHERLOCK application. This test allows a turnaround time of an hour from sampling to the report of the results. The very simple handling underlines the potential as a point-of-care test (POCT) for COVID 19 testing. […] The method was validated on 17 patient samples. It could detect 12 positive and 5 negative samples, 2 of 3 replicates were scored positive in infected patients. […] The inventors of STOPCovid are constantly improving the Covid-19 detection method for rapid testing. […] Scientists in the United States and India developed new tests on Genome level, which are nearly as fast as rapid antigen tests, but more sensitive.
  • #78 Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)-Healgen-Products and Services
    https://www.healgen.com/covid19-influenza-a-b
    Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 by their healthcare provider within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests. […] This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens. […] Results are for the in vitro detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus protein antigens, but do not differentiate, between SARS-CoV and SARS-CoV-2 viruses and are not intended to detect influenza C antigens.
  • #79 Lateral flow 4.0 and the next generation of rapid diagnostics | Article | Chemistry World
    https://www.chemistryworld.com/industry/lateral-flow-40-and-the-next-generation-of-rapid-diagnostics/4013369.article
    As a result, there is a need for an accurate and rapid diagnostic test to deliver reliable results, including for those without symptoms, quickly at the point of care. […] Rapid and accurate testing is an essential component of the response to the Covid-19 pandemic – being able to test outside of medical or lab environments, such as drive-through centres or transit hubs, is vital. […] A lateral flow device incorporating conjugated polymer nanoparticles can aid detection of asymptomatic Covid-19 carriers. […] The result is a highly sensitive and robust diagnostic platform, known as Claritas. […] These applications, and the great potential of the platform to support Covid-19 testing, highlight examples of how Claritas is already being adapted to transform diagnostics and enhance healthcare.
  • #80
    https://www.who.int/publications/i/item/9789240067172
    Lateral-flow rapid diagnostic tests (RDTs) continue to play a vital role in global health in the management and diagnosis of infectious diseases, including malaria, HIV and COVID-19. […] Their utility is, however, compromised every time a test is incorrectly performed or interpreted or its result is not available in a timely manner for clinical decisionmaking and surveillance. […] As companion tools, RDT readers promote more consistent, accurate test performance, interpretation and reporting, as recognized in a revision of the ASSURED criteria and in comparisons of manual and automatic reports of positivity. […] one that serves as a medical reader, which provides its interpretation to its user as a basis for diagnosis and treatment as a regulated medical device or in vitro diagnostic.
  • #81 How lateral flow tests are becoming a diagnostic gamechanger | Medical research | The Guardian
    https://www.theguardian.com/science/2025/mar/09/how-lateral-flow-tests-are-becoming-a-diagnostic-gamechanger
    „I think there are huge opportunities for LFTs to identify which patients with symptoms of infection require antibiotics and which don’t,” Daniels said. […] „One of the advantages of lateral flow is that it can multiplex, so you can measure different things at the same time,” said Umaima Ahmad, the chief executive and co-founder of 52 North, which developed Neutrocheck. […] „I think we have to recognise that the quality of lateral flow tests is not as high as that of laboratory tests, and so we have to make sure that we integrate them into clinical systems in a careful way.” […] „While the use of self-testing kits, including lateral flow tests, can have benefits for patient care, it’s vital that a thorough pilot and evaluation is undertaken before any wider rollout of self-testing initiatives takes place in the NHS,” said Prof Kamila Hawthorne, the chair of the Royal College of GPs.
  • #82 Lateral Flow Market 2.0: Innovation and Growth in the Post-COVID-19 Diagnostics Market
    https://www.abingdonhealth.com/lateral-flow-market-2-0-innovation-and-growth-post-covid19/
    Lateral flow testing is over 30 years old; with the first (UK-developed) lateral flow pregnancy tests hitting the market in the 1980s. […] COVID-19 has had a dramatic impact, which I believe is leading to a further cycle of innovation and growth. […] The use of COVID-19 rapid antigen tests massively expanded the use of these cost-effective and easy-to-use tests during the pandemic, therefore reducing the barriers to adoption as people became very familiar with the use of the technology. […] As we emerge from the COVID-19 pandemic, I believe we are seeing significant further awareness of, and expansion in, the use of lateral-flow tests; and the emergence of “Lateral flow Market 2.0” with this growth driven by Innovation, shifting the industry back into a phase of significant growth. […] Abingdon Health worked, and continues to work, closely with Oxford-based Vatic Health during the pandemic to develop a saliva-based COVID-19 rapid antigen test.
  • #83 Lateral flow technology scale up strengthens pandemic preparedness
    https://www.selectscience.net/article/lateral-flow-technology-scale-up-strengthens-pandemic-preparedness
    „COVID-19 made the public aware of lateral flow technology, and now more companies are developing tests for other infectious diseases and even environmental monitoring,” Wu notes. „The pandemic has demonstrated the importance of having robust and flexible diagnostic capabilities that can be deployed quickly and effectively in diverse settings.” […] The COVID-19 pandemic has undeniably reshaped the landscape of diagnostic testing, underscoring the importance of rapid and accessible point-of-care solutions. Lateral flow technology, with its versatility and ease of use, is poised to play a pivotal role in future pandemic preparedness and beyond.
  • #84 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner
    https://www.nature.com/articles/s44222-022-00007-3
    Lateral flow tests (LFTs) were adopted at an unprecedented scale during the COVID-19 pandemic, enabling access to testing beyond healthcare settings. […] The acceptability and feasibility of large-scale testing with lateral flow tests (LFTs) for clinical and public health purposes has been demonstrated during the COVID-19 pandemic. […] Key barriers to COVID-19 LFT development and adoption include lack of access to well characterized samples, limited accuracy, lack of connectivity, lack of evidence of cost-effectiveness, regulatory delays and centralized manufacturing capabilities. […] LFTs could also play an important part in the detection of other diseases of epidemic potential and antimicrobial resistance. […] The accuracy and, in particular, the sensitivity of LFTs is lower than that of reference RT-PCR methods, ranging between 34.1% and 88.1% for SARS-CoV-2 antigen LFTs, with an overall specificity of 99.6%.
  • #85 An Introduction to the Lateral Flow Test: Strengths, Limitations and Applications | Technology Networks
    https://www.technologynetworks.com/diagnostics/articles/an-introduction-to-the-lateral-flow-test-strengths-limitations-and-applications-370382
    A lateral flow test (LFT) is a simple, quick and cheap assay that can detect the presence of target antigen(s) or antibody(ies) in a liquid sample. […] Most people have probably experienced one or more of the home SARS-CoV-2 LFTs firsthand. The majority of the devices people use at home are designed to test for the presence of the virus itself (i.e., might they be infectious?) rather than for antibodies indicating exposure or vaccination. As such, they are directed to bind to the exposed and accessible antigenic parts of the virus such as the spike, envelope, membrane or nucleocapsid proteins. […] Although SARS-CoV-2 may be the human pathogen that first springs to mind when we think about the applications of LFTs for infectious disease, they have also found utility for detecting a range of targets including the Plasmodium parasites that cause malaria, Mycobacterium tuberculosis, the causative agent of TB, hepatitis B virus and human immunodeficiency virus (HIV).
  • #86 The rise of the lateral flow test: everything you need to know about lateral flow tests in five steps – Una Health
    https://unahealth.co.uk/blog/the-rise-of-the-lateral-flow-test-everything-you-need-to-know-about-lateral-flow-tests-in-five-steps/
    The COVID-19 pandemic saw a boom in the availability of lateral flow tests but we quickly learnt that not all lateral flow tests, and their evaluations, are created equally. […] As we move slowly out of the COVID-19 pandemic, lateral flow tests look here to stay. Healthcare professionals, policy makers and the public now have an awareness of the value and benefits of lateral flow tests and how they can contribute to much needed change in infection diagnostics.
  • #87 How lateral flow tests are becoming a diagnostic gamechanger | Medical research | The Guardian
    https://www.theguardian.com/science/2025/mar/09/how-lateral-flow-tests-are-becoming-a-diagnostic-gamechanger
    Familiar from the Covid era, the tests are becoming incredibly versatile, with potential uses including detecting killers such as strokes and sepsis […] During the pandemic, many of us got used to using lateral flow tests to check if we were infected with Covid or were likely to infect others. […] LFTs are designed to rapidly detect a molecule of interest without the need for specialised, costly equipment, by incorporating highly specific antibodies into a plastic cartridge. […] „First of all, there’s a much wider awareness – not only with the general public but the scientific community – of lateral flow, and treating it as a more serious alternative to laboratory testing,” said Dr Chris Hand, the chair and co-founder of Abingdon Health, which develops and manufactures LFTs on behalf of other companies.
  • #88 Rapidly adaptable automated interpretation of point-of-care COVID-19 diagnostics | Communications MedicineClose bannerClose banner
    https://www.nature.com/articles/s43856-023-00312-x
    With the introduction of SARS-CoV-2 antigen LFAs, these errors with test interpretation have been confirmed with community health workers, with considerable uncertainties about how to perform and interpret different rapid tests reported widely by the general public. […] Mobile apps that automatically interpret results from point-of-care diagnostic tests present an opportunity to address these challenges, with high acceptability among healthcare workers for HIV and sexually transmitted infections, but current approaches are not scalable. […] This approach, called AutoAdapt POC, achieves the goal of rapid adaptation with the development of three components, automated membrane extraction, self-supervised learning specifically designed to preserve image edges that are critical for recognizing faint test kit images, and few-shot learning to adapt a pre-trained model to different test kits. […] The algorithm correctly identified 100% of images; without a false negative as interpreted by experts. […] AutoAdapt POC provides quality assurance, linkage to care, and public health tracking to untrained users operating a diverse and dynamic set of POC diagnostic tests.
  • #89 Azthena logo with the word Azthena
    https://www.news-medical.net/news/20230123/Review-on-lateral-flow-test-use-spearheaded-by-SARS-CoV-2-pandemic.aspx
    To conclude, based on the review findings, next-generation of next-generation LFTs could provide means for rapid and decentralized testing with high sensitivity and specificity at a mass scale. […] Efforts must be made to overcome LFT shortcomings, such as high false-negative rates, to provide next-generation diagnostic LFTs, with an equitable distribution, across the globe, to improve global preparedness against pathogens.
  • #90 How lateral flow tests are becoming a diagnostic gamechanger | Medical research | The Guardian
    https://www.theguardian.com/science/2025/mar/09/how-lateral-flow-tests-are-becoming-a-diagnostic-gamechanger
    „The beauty of lateral flows is that they are easy to use but also easy for people to understand: you put a sample here, and a line means positive; no line is negative,” said Gonzalo Ladreda, the chief executive of Upfront Diagnostics, which is developing LFTs for early stroke detection. […] „Most things you want to measure, you can measure with lateral flow,” Hand said. […] A major growth area is healthcare. Besides early stroke detection, UK trials of two LFTs to detect the deadly bloodstream infection sepsis are getting started. […] „If you’re in your final month of life and you’re trying to deliver your bucket list, you don’t want to spend 12 hours waiting in an emergency department to be told to go home,” said Dr Ron Daniels, an NHS intensive care consultant and founder and chief medical officer of the UK Sepsis Trust.
  • #91 Lateral Flow Market 2.0: Innovation and Growth in the Post-COVID-19 Diagnostics Market
    https://www.abingdonhealth.com/lateral-flow-market-2-0-innovation-and-growth-post-covid19/
    We saw the emergence of these techniques through the pandemic. US company Detect Inc., launched a home-use COVID-19 test based upon this technology. […] Companies such as Senzo continue to push the boundaries of the use of this “PCR-Accurate Lateral Flow” technology in COVID-19 as well as into other infectious disease applications. […] Innovation is rife within the lateral flow market, driven in part by the impact of COVID-19 on the decentralization of testing; and this is growing the range of applications to which lateral flow technology can be applied.
  • #92
    https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays
    Direct detection of SARS-CoV-2 viral proteins (antigens) in nasal swabs and other respiratory secretions using lateral flow immunoassays (also known as rapid diagnostic tests, RDTs) offers a faster and less expensive method to test for SARS-CoV-2 than the reference method, nucleic acid amplification tests (NAATs). […] This interim guidance offers recommendations on the priority uses of antigen-detecting rapid diagnostic tests (Ag-RDTs) in specific populations and settings, including (i) for primary case detection in symptomatic individuals suspected to be infected and asymptomatic individuals at high risk of COVID-19, (ii) for contact tracing, (iii) during outbreak investigations and (iv) to monitor trends of disease incidence in communities. […] Ag-RDTs meeting minimum performance requirements can be used outside of clinical and laboratory settings, including in communities, by trained operators in accordance with instructions. […] This document updates the first interim guidance on the potential role of Ag-RDTs in the diagnosis of COVID-19 (Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays) released on 11 September 2020.
  • #93 IDSA Guidelines on the Diagnosis of COVID-19: Antigen Testing
    https://www.idsociety.org/practice-guideline/covid-19-guideline-antigen-testing/
    Version 2.0.0 has been released and includes updated and new recommendations for COVID-19 Antigen Testing for symptomatic and asymptomatic persons in both medical and non-medical settings. […] Immunoassays designed to detect SARS-CoV-2 protein antigens (Ag) are commonly used to diagnose COVID-19. The most widely used tests are lateral flow assays that generate results in approximately 15 minutes for diagnosis at the point-of-care. […] The panel made ten diagnostic recommendations. These recommendations address Ag testing in symptomatic and asymptomatic individuals and assess single versus repeat testing strategies. […] U.S. Food and Drug Administration (FDA) SARS-CoV-2 Ag tests with Emergency Use Authorization (EUA) have high specificity and low to moderate sensitivity compared to nucleic acid amplification testing (NAAT).
  • #94 IDSA Guidelines on the Diagnosis of COVID-19: Antigen Testing
    https://www.idsociety.org/practice-guideline/covid-19-guideline-antigen-testing/
    The overall quality of available evidence supporting use of Ag testing was graded as very low to moderate. […] The overall specificity of SARS-CoV-2 Ag tests was 99% compared to standard nucleic acid amplification testing (NAAT). […] A single Ag test has high specificity; a positive result can be used to guide treatment and isolation decisions without confirmation. […] For optimal performance, Ag tests should be performed within 5 days of symptom onset. […] The panel suggests using standard NAAT over Ag tests if standard NAAT is available and results of testing will be timely. […] The panel recognizes the value of diagnosing COVID-19 quickly, since treatment options are typically approved for administration within 5 days of symptom onset. […] A negative Ag test result reduces the likelihood of SARS-CoV-2 infection. However, the longer the time since testing, the more this likelihood reduction wanes, especially early in infection when virus replication may be rapid.
  • #95 IDSA Guidelines on the Diagnosis of COVID-19: Antigen Testing
    https://www.idsociety.org/practice-guideline/covid-19-guideline-antigen-testing/
    The overall quality of available evidence supporting use of Ag testing was graded as very low to moderate. […] The overall specificity of SARS-CoV-2 Ag tests was 99% compared to standard nucleic acid amplification testing (NAAT). […] A single Ag test has high specificity; a positive result can be used to guide treatment and isolation decisions without confirmation. […] For optimal performance, Ag tests should be performed within 5 days of symptom onset. […] The panel suggests using standard NAAT over Ag tests if standard NAAT is available and results of testing will be timely. […] The panel recognizes the value of diagnosing COVID-19 quickly, since treatment options are typically approved for administration within 5 days of symptom onset. […] A negative Ag test result reduces the likelihood of SARS-CoV-2 infection. However, the longer the time since testing, the more this likelihood reduction wanes, especially early in infection when virus replication may be rapid.
  • #96 IDSA Guidelines on the Diagnosis of COVID-19: Antigen Testing
    https://www.idsociety.org/practice-guideline/covid-19-guideline-antigen-testing/
    The panel suggests using a single standard NAAT (i.e., rapid RT-PCR or laboratory-based NAAT) rather than a strategy of two consecutive rapid Ag tests. […] The panel suggests using a single (i.e., one-time) Ag test over no testing in specific situations. […] The panel suggests using a single standard NAAT (i.e., rapid RT-PCR or laboratory-based NAAT) over a single rapid Ag test. […] The panel suggests repeat Ag testing if standard NAAT testing or results are not available in a timely manner and a first Ag test is negative. […] The IDSA panel suggests neither for nor against two consecutive Ag tests over no testing for the diagnosis of SARS-CoV-2 infection. […] The IDSA panel suggests neither for nor against Ag testing over no testing for asymptomatic individuals planning to attend large gatherings. […] The IDSA panel suggests for either point-of-care or laboratory-based Ag testing. […] The IDSA panel suggests either observed or unobserved self-collection of swab specimens for Ag testing if self-collection is performed.
  • #97 IDSA Guidelines on the Diagnosis of COVID-19: Antigen Testing
    https://www.idsociety.org/practice-guideline/covid-19-guideline-antigen-testing/
    The panel suggests using a single standard NAAT (i.e., rapid RT-PCR or laboratory-based NAAT) rather than a strategy of two consecutive rapid Ag tests. […] The panel suggests using a single (i.e., one-time) Ag test over no testing in specific situations. […] The panel suggests using a single standard NAAT (i.e., rapid RT-PCR or laboratory-based NAAT) over a single rapid Ag test. […] The panel suggests repeat Ag testing if standard NAAT testing or results are not available in a timely manner and a first Ag test is negative. […] The IDSA panel suggests neither for nor against two consecutive Ag tests over no testing for the diagnosis of SARS-CoV-2 infection. […] The IDSA panel suggests neither for nor against Ag testing over no testing for asymptomatic individuals planning to attend large gatherings. […] The IDSA panel suggests for either point-of-care or laboratory-based Ag testing. […] The IDSA panel suggests either observed or unobserved self-collection of swab specimens for Ag testing if self-collection is performed.
  • #98 IDSA Guidelines on the Diagnosis of COVID-19: Antigen Testing
    https://www.idsociety.org/practice-guideline/covid-19-guideline-antigen-testing/
    The panel suggests using a single standard NAAT (i.e., rapid RT-PCR or laboratory-based NAAT) rather than a strategy of two consecutive rapid Ag tests. […] The panel suggests using a single (i.e., one-time) Ag test over no testing in specific situations. […] The panel suggests using a single standard NAAT (i.e., rapid RT-PCR or laboratory-based NAAT) over a single rapid Ag test. […] The panel suggests repeat Ag testing if standard NAAT testing or results are not available in a timely manner and a first Ag test is negative. […] The IDSA panel suggests neither for nor against two consecutive Ag tests over no testing for the diagnosis of SARS-CoV-2 infection. […] The IDSA panel suggests neither for nor against Ag testing over no testing for asymptomatic individuals planning to attend large gatherings. […] The IDSA panel suggests for either point-of-care or laboratory-based Ag testing. […] The IDSA panel suggests either observed or unobserved self-collection of swab specimens for Ag testing if self-collection is performed.
  • #99 COVID Testing – COVID-19 Protocols
    https://covidprotocols.org/chapters/covid-testing/
    The standard of care for diagnostic testing symptomatic patients is PCR-based testing, as it has the best sensitivity and specificity. […] When PCR-based testing capacity is restricted, use of the antigen test can increase testing capacity as well as offer advantages in terms of more low-cost testing with short turnaround time. The antigen test is discussed in more detail in Types of Test Section. […] Rapid Antigen Testing (antigen rapid diagnostic test or Ag RDT for short). […] If positive, admit as a confirmed case or isolate at home, initiate contact tracing. If in a high prevalence setting or in a symptomatic patient with likely COVID-19, confirmatory PCR testing is not needed. […] More options for the use of rapid antigen tests for COVID-19 for asymptomatic screening and in public health surveillance have been published by the European Center for Disease Prevention and Control and by the Africa CDC.
  • #100 COVID-19 testing – NHS
    https://www.nhs.uk/conditions/covid-19-rapid-lateral-flow-test/
    A COVID-19 rapid lateral flow is a test you do yourself to check for COVID-19. They are available for free on the NHS to people who are eligible for COVID-19 treatment. […] A rapid lateral flow test is done to check if you have COVID-19. […] If you’re eligible for COVID-19 treatments, you’ll need to take a COVID-19 rapid lateral flow test if you have any symptoms of COVID-19. […] You can get free COVID-19 rapid lateral flow tests from a pharmacy if you’re eligible for COVID-19 treatments because you’re at highest risk of getting seriously ill from COVID-19. […] COVID-19 rapid lateral flow tests show the result on the testing device within a few minutes. […] If you get a positive COVID-19 rapid lateral flow test result, it means it’s very likely you have COVID-19. […] If you test positive for COVID-19, try to stay home and avoid meeting people for: 3 days after the day the test was taken if you’re under 18 years – children and young people tend to be infectious for less time than adults; 5 days after the day you took your test if you’re aged 18 or over. […] If you get a negative COVID-19 rapid lateral flow test result, it means it’s unlikely you have COVID-19. […] If you test negative and you’re eligible for COVID-19 treatments, you need to do a total of 3 rapid lateral flow tests over 3 days (1 test a day) if you continue to have COVID-19 symptoms.
  • #101 How Do Rapid Antigen Tests Work? | Today’s Clinical Lab
    https://www.clinicallab.com/how-do-rapid-antigen-tests-work-26279
    If, after the instructed time has passed, any line is visible on the test line, the result is considered positive. The specificity of lateral flow tests is generally very high (meaning there is a small chance of false positive results). […] Unlike positive results, where you can be quite confident in the result, negative results don’t necessarily mean you are truly negative. With any of these tests, two major aspects influence the possibility of receiving a negative result: the way the sample was acquired and the timing of the infection. […] The biggest factor, though, is the timing of the sample. For COVID-19 tests, if the sample is taken too early (before symptoms are present), or too late (beyond the first week of symptoms), a negative result may occur. In other words, receiving a negative result doesn’t mean you are free of infection.
  • #102 How Do Rapid Antigen Tests Work? | Today’s Clinical Lab
    https://www.clinicallab.com/how-do-rapid-antigen-tests-work-26279
    If, after the instructed time has passed, any line is visible on the test line, the result is considered positive. The specificity of lateral flow tests is generally very high (meaning there is a small chance of false positive results). […] Unlike positive results, where you can be quite confident in the result, negative results don’t necessarily mean you are truly negative. With any of these tests, two major aspects influence the possibility of receiving a negative result: the way the sample was acquired and the timing of the infection. […] The biggest factor, though, is the timing of the sample. For COVID-19 tests, if the sample is taken too early (before symptoms are present), or too late (beyond the first week of symptoms), a negative result may occur. In other words, receiving a negative result doesn’t mean you are free of infection.
  • #103
    https://ihealthlabs.com/pages/ihealth-covid-19-antigen-rapid-test-details?srsltid=AfmBOorS5qdmZdMr3wTmBTOc1rFFbX2EcKSi4Aibd8ZoOH7_mdeG1BPv
    Serial testing is when a single person is tested for COVID-19 more than once. […] If you have COVID-19 symptoms and are within the first 7 days of symptom onset, you can use one single test of the iHealth COVID-19 Antigen Rapid Test. […] The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. […] The performance of this test was established based on the evaluation of a limited number of clinical specimens collected in between May and October 2021.
  • #104 A guide to COVID-19 tests for the public
    https://www.rcpath.org/profession/coronavirus-resource-hub/guide-to-covid-19-tests-for-members-of-the-public.html
    The tests commonly available for SARS-CoV-2 can detect either: […] the surrounding proteins – detected by the rapid lateral flow devices. […] These are the rapid tests that are used in the community. They are convenient because they can give a result within 30 minutes and do not need a laboratory. […] They detect proteins from the virus, not RNA. […] These tests are very different from PCR. They are not suitable for diagnosing individual patients who suspect they may be infected because they have symptoms. […] Lateral flow tests are intended for picking up additional infected cases who would otherwise be missed because they don’t have any symptoms. […] These tests are not as sensitive as PCR. They are simply a convenient way of picking up a proportion of undiagnosed people who have no symptoms. […] If a person tests positive with these tests, they need to confirm this by having a more accurate PCR. […] A negative lateral flow test should not be used to rule out infection or indicate that it is safe to do something such as visit relatives.
  • #105 In Vitro Diagnostics EUAs – Antigen Diagnostic Tests for SARS-CoV-2 | FDA
    https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
    March 24, 2023 – The FDA has finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). The guidances outline the FDA’s general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA’s recommendations for: […] In Vitro Diagnostic EUAs: Overview and Templates […] The table below includes information about authorized SARS-CoV-2 antigen diagnostic tests that have been authorized individually. These emergency use authorizations (EUAs) have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories.
  • #106 BinaxNOW: What You Need to Know | Abbott Newsroom
    https://www.abbott.com/BinaxNOW-Tests-NAVICA-App.html
    The BinaxNOW™ COVID-19 Antigen Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal (nares) swab samples from individuals 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first seven days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. […] The BinaxNOW™ COVID-19 tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization. They have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
  • #107 Rapid Test Flu_Covid – ProGnosis Biotech
    https://www.prognosis-biotech.com/product/rapid-test-flu_covid/
    Rapid Test FLU_COVID is a qualitative, lateral flow test designed to detect the presence or absence SARS-CoV-2 and Influenza virus antigens in nasal or nasopharyngeal swab specimens. It differentiates between Covid-19 (SARS-CoV-2) and the Flu (Influenza, Types A and B). […] Clinical performance with 956 nasopharyngeal specimens (prior confirmed with RT-PCR assay) showed: 97.44 % sensitivity 99.77 % specificity for Influenza A,100 % sensitivity 99.68 % specificity for Influenza B and 99.2 % sensitivity 99.8% specificity for SARS-CoV-2. […] Clinical performance with 956 nasal specimens (prior confirmed with RT-PCR assay) showed: 96.15 % sensitivity 99.77 % specificity for Influenza A,100 % sensitivity 99.68 % specificity for Influenza B and 98,9 % sensitivity 99.8% specificity for SARS-CoV-2. […] The test has received the CE-IVD. […] Test should only be conducted by medical personnel.
  • #108 What is lateral flow testing and how could it be deployed against coronavirus?verifiedverifiedverifiedverifiedverifiedverifiedverifiedverifiedverifiedverified
    https://www.gavi.org/vaccineswork/what-lateral-flow-testing-and-how-could-it-be-deployed-against-coronavirus
    The World Health Organization recommends that rapid diagnostic tests for SARS-CoV-2 must have a minimum sensitivity of 70% and at least 97% specificity. […] Independent tests by the Foundation for Innovative New Diagnostics (FIND) found that one such test, by the South Korean company SD Biosensor, had a clinical specificity of 99.3% and a clinical sensitivity of 76.6% – making it approximately 20% less sensitive than PCR tests. […] Even though they are less accurate than PCR tests, their low cost, speed and ease of use makes lateral flow tests particularly attractive to countries that do not have extensive laboratory facilities or trained health workers to easily conduct PCR tests. With their high specificity, existing COVID-19 lateral flow tests are potentially useful for confirming that someone suspected of having COVID-19 really has it.
  • #109 British manufacturer SureScreen Diagnostics to supply 20 million rapid lateral flow – GOV.UK
    https://www.gov.uk/government/news/british-manufacturer-surescreen-diagnostics-to-supply-20-million-rapid-lateral-flow
    The tests have already been validated by PHE in the lab and are now in their final stage of validation in clinical trials. The tests have been proven to detect the B117 Kent variant of COVID-19, and are already CE marked and MHRA registered. Results for the test at the laboratory validation stage show sensitivity against high viral loads was 97.1% and specificity was 99.9% […] Rapid lateral flow tests strengthen our national response to the virus significantly, helping us to identify the around 1 in 3 people who are asymptomatic and break chains of transmission in our workplaces and communities […] SureScreens rapid tests will help prevent the spread of infection, while supporting jobs and the UK industry across the country […] We believe our rapid antigen tests can really help in screening people both in the community and in clinical settings. Routine testing is crucial to help business, as well as hospitals and GPs
  • #110 SciELO Brazil – A Review on COVID-19 Diagnosis Tests Approved for Use in Brazil and the Impact on Pandemic Control A Review on COVID-19 Diagnosis Tests Approved for Use in Brazil and the Impact on Pandemic Control
    https://www.scielo.br/j/babt/a/Dv69YpJgvgymMmnk5VMZfVQ/
    With the COVID-19 pandemic, many diagnostic tests (molecular or immunological) were rapidly standardised, given the urgency of the situation, many are still in the process of being validated. […] The methodologies of these products are based on the detection of nucleic-acid (15.8%), antigen (13%) and antibody (71.2%). […] In conclusion, this review showed that Brazil is dependent on external technology to respond to pandemics, epidemics and endemics disease and needs to improve its biotechnological scheme to solve further diseases outbreaks. […] Therefore, in order to manage a severe pandemic outbreak, an accurate diagnostic is of significant importance. […] Initially, the ANVISA published in March 17th, 2020 a temporarily resolution with the registration for approved use of diagnostic kits due to the public health SARS-CoV-2 emergency.
  • #111 SciELO Brazil – A Review on COVID-19 Diagnosis Tests Approved for Use in Brazil and the Impact on Pandemic Control A Review on COVID-19 Diagnosis Tests Approved for Use in Brazil and the Impact on Pandemic Control
    https://www.scielo.br/j/babt/a/Dv69YpJgvgymMmnk5VMZfVQ/
    Previous ANVISA resolution from 2015 regarding the approval of diagnostic tests explicitly prohibits the use of the serological tests to the diagnosis of infectious diseases and of compulsory notification in form of auto-testing. […] At the date of February 8th, 2021, ANVISA has approved 508 diagnostic tests, while 132 are pending approval and 130 not approved. […] As previously mentioned, COVID-19 can be diagnosed directly through the detection of the SARS-CoV-2 nuclei acid or proteins (detection of antigen) presents on a clinical sample, and also indirectly by the identification of host defense molecules, like the antibodies. […] The immunochromatography technique is the most solicited method to an approval possibly due to its being a rapid, simple, sensible and importantly, a point-of-care test.
  • #112 Lateral Flow Test: Design, Materials & Manufacturing Insights
    https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/clinical-testing-and-diagnostics-manufacturing/ivd-manufacturing/lateral-flow-test-insights?srsltid=AfmBOorE_BsYkoMC5CnzPxzzFXpGi9xSopO7F-i_NW22pfUa8h4Q090E
    By employing these screening strategies and optimizing the assay components, developers can enhance the performance, reliability, stability, and shelf life of rapid lateral flow tests. […] Membrane selection and specifications can significantly impact the sensitivity of a rapid lateral flow test. […] Uncharacterized variations in a single material, reagent, or process can lead to inconsistent performance of a lateral flow test, potentially resulting in false negatives or false positives. […] Reproducibility is critical in diagnostic test strip development, as the final product must be consistent in its performance if it is to be commercially successful.
  • #113 COVID Testing – COVID-19 Protocols
    https://covidprotocols.org/chapters/covid-testing/
    Rapid Antigen RDTs are an alternative to NAAT as screening tests where testing capacity is limited and the proportion of test positivity is high (10%). […] The minimum performance requirements for Ag-RDT set by the WHO are 80% sensitivity and 97% specificity compared to a NAAT reference assay. […] Antigen RDTs will be useful to implement a test and treat program (widespread screening, early detection of disease, and prompt initiation of appropriate treatment).
  • #114 Lateral Flow Test: Design, Materials & Manufacturing Insights
    https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/clinical-testing-and-diagnostics-manufacturing/ivd-manufacturing/lateral-flow-test-insights?srsltid=AfmBOorE_BsYkoMC5CnzPxzzFXpGi9xSopO7F-i_NW22pfUa8h4Q090E
    Lateral flow test strips have revolutionized the field of diagnostics, offering quick and convenient testing for a wide range of analytes. […] The COVID-19 pandemic further boosted the popularity of rapid antigen testing, leading to the emergence of at-home testing products utilizing lateral flow technology. […] Overall, the use of nitrocellulose membrane in lateral flow assays provides a reliable and cost-effective platform for rapid diagnostic testing across multiple applications. […] Essential instruments for developing a rapid lateral flow test include a precision dispensing system for spraying capture reagents onto the membrane and a precision cutting system for converting master cards into individual test strips. […] Capture reagents are essential components of lateral flow test strips that enable the detection of target molecules.
  • #115 Antigen and Molecular Tests for COVID-19 | COVID-19 Testing Toolkit
    https://covid19testingtoolkit.centerforhealthsecurity.org/testing-trackers/antigen-and-molecular-tests-for-covid-19
    Current antigen and molecular tests with FDA EUA status. […] Included in the complete list are sensitivity and specificity measures, specimens required, target genes, test details, and manufacturing capabilities (if provided). […] The terms sensitivity and specificity may not appear in the manufacturers information sheets, but are often reported as positive percent agreement and negative percent agreement. […] A highly sensitive test should capture all true positive results. […] A highly specific test should rule out all true negative results. […] These measures are not independently validated by the Johns Hopkins Center for Health Security.
  • #116 In Vitro Diagnostics EUAs – Antigen Diagnostic Tests for SARS-CoV-2 | FDA
    https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
    In addition to COVID-19 tests issued EUAs, there are antigen SARS-CoV-2 diagnostic tests that have been authorized through traditional premarket review pathways. […] On September 23, 2021, the FDA revised the EUAs of certain molecular, antigen, and serology tests to establish additional Conditions of Authorization in response to the continued emergence of new variants of SARS-CoV-2. […] The November 1, 2022 revision requires test developers in the scope of the revision to take certain actions, including submitting a supplemental EUA request to the FDA with updated labeling to reflect the revised authorized uses, as follows:
  • #117 What Does a Positive Covid Test Look Like? | The Scientist
    https://www.the-scientist.com/what-does-a-positive-covid-test-look-like-68965
    The manufacturers would say that this is quite simply because you have these gold particles, which forms the colored element, and if that’s treated with an acidic solution, you may get it clumping together or aggregating. […] Anytime you get a false positive, especially if it’s a false positive that’s arising from improper use of the test, you’re actually damaging the…public health system that’s there to protect us. […] If you have a testing program where you test people a lot of the time…especially if you’re screening people without symptoms, every time you get a false positive, the person involved and also all those people who’ve been in contact with them have to be treated as if they have this very dangerous, highly contagious infectious disease. […] A false positive covid rapid test shows a line in the lateral flow device’s test region, even though there is no SARS-CoV-2 virus present in the sample. Although it is possible, false positive tests are uncommon when test instructions are followed correctly.
  • #118 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner
    https://www.nature.com/articles/s44222-022-00007-3
    The rapid development of target product profiles, first by the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) and later by the WHO, provided clear expectations to manufacturers on desired design features, and were welcomed by industry. […] The lessons learned from COVID-19 should continue to inform in vitro diagnostics regulations and manufacturing practices.
  • #119 Point-of-care COVID-19 diagnostics powered by lateral flow assay – PMC Lock
    https://pmc.ncbi.nlm.nih.gov/articles/PMC8487324/
    The diagnosis of SARS-CoV-2 infection remains the main driving force to alleviate the COVID-19 pandemic. Rapid testing needs should be provided at the early stage to control the spread and resurgence of COVID-19, thus contributing to the rapid identification of new COVID-19-infected persons and the implementation of their isolation and quarantine measures. In this regard, LFA-assisted rapid diagnostic tests play an important role in targeting SARS-CoV-2 specific biomarkers, such as viral RNA, antibodies, antigens, and whole virus. Various rapid diagnostic technologies using the portable LFA platform have sprung up, some of which have been developed into test kits for rapidly diagnosing COVID-19.
  • #120 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner
    https://www.nature.com/articles/s44222-022-00007-3
    The viral load threshold for transmission has been proposed to be about 1,000,000 copies, and therefore, rapid antigen tests are considered to be a good public health tool with which to identify infectious people and those at risk of transmitting SARS-CoV-2 to others, thus reducing community transmission. […] In many high-income regions, COVID-19 self-tests have been widely available since 2021, often subsidized or free to the public through pharmacies or online ordering. […] The COVID-19 pandemic has revealed enormous inequities in access to tests, vaccines and therapeutics. […] The COVID-19 pandemic has reduced public access to care, and antimicrobial prescribing and childhood immunizations have decreased. […] The COVID-19 pandemic has affected the approach of regulators with regard to approving lateral flow tests (LFTs), including early engagement with and guidance to test developers.
  • #121 Rapidly adaptable automated interpretation of point-of-care COVID-19 diagnostics | Communications MedicineClose bannerClose banner
    https://www.nature.com/articles/s43856-023-00312-x
    With the introduction of SARS-CoV-2 antigen LFAs, these errors with test interpretation have been confirmed with community health workers, with considerable uncertainties about how to perform and interpret different rapid tests reported widely by the general public. […] Mobile apps that automatically interpret results from point-of-care diagnostic tests present an opportunity to address these challenges, with high acceptability among healthcare workers for HIV and sexually transmitted infections, but current approaches are not scalable. […] This approach, called AutoAdapt POC, achieves the goal of rapid adaptation with the development of three components, automated membrane extraction, self-supervised learning specifically designed to preserve image edges that are critical for recognizing faint test kit images, and few-shot learning to adapt a pre-trained model to different test kits. […] The algorithm correctly identified 100% of images; without a false negative as interpreted by experts. […] AutoAdapt POC provides quality assurance, linkage to care, and public health tracking to untrained users operating a diverse and dynamic set of POC diagnostic tests.
  • #122 Lateral flow technology scale up strengthens pandemic preparedness
    https://www.selectscience.net/article/lateral-flow-technology-scale-up-strengthens-pandemic-preparedness
    „COVID-19 made the public aware of lateral flow technology, and now more companies are developing tests for other infectious diseases and even environmental monitoring,” Wu notes. „The pandemic has demonstrated the importance of having robust and flexible diagnostic capabilities that can be deployed quickly and effectively in diverse settings.” […] The COVID-19 pandemic has undeniably reshaped the landscape of diagnostic testing, underscoring the importance of rapid and accessible point-of-care solutions. Lateral flow technology, with its versatility and ease of use, is poised to play a pivotal role in future pandemic preparedness and beyond.
  • #123 Azthena logo with the word Azthena
    https://www.news-medical.net/news/20230123/Review-on-lateral-flow-test-use-spearheaded-by-SARS-CoV-2-pandemic.aspx
    To conclude, based on the review findings, next-generation of next-generation LFTs could provide means for rapid and decentralized testing with high sensitivity and specificity at a mass scale. […] Efforts must be made to overcome LFT shortcomings, such as high false-negative rates, to provide next-generation diagnostic LFTs, with an equitable distribution, across the globe, to improve global preparedness against pathogens.
  • #124 How lateral flow tests are becoming a diagnostic gamechanger | Medical research | The Guardian
    https://www.theguardian.com/science/2025/mar/09/how-lateral-flow-tests-are-becoming-a-diagnostic-gamechanger
    „I think there are huge opportunities for LFTs to identify which patients with symptoms of infection require antibiotics and which don’t,” Daniels said. […] „One of the advantages of lateral flow is that it can multiplex, so you can measure different things at the same time,” said Umaima Ahmad, the chief executive and co-founder of 52 North, which developed Neutrocheck. […] „I think we have to recognise that the quality of lateral flow tests is not as high as that of laboratory tests, and so we have to make sure that we integrate them into clinical systems in a careful way.” […] „While the use of self-testing kits, including lateral flow tests, can have benefits for patient care, it’s vital that a thorough pilot and evaluation is undertaken before any wider rollout of self-testing initiatives takes place in the NHS,” said Prof Kamila Hawthorne, the chair of the Royal College of GPs.

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