Szybki test przepływowy na covid-19
Charakterystyka, pielęgnacja i opieka

Szybkie testy przepływowe (LFT) na COVID-19 wykorzystują technologię immunochromatograficzną do wykrywania antygenów SARS-CoV-2 w próbkach wymazu z przedniej części jamy nosowej, umożliwiając uzyskanie wyniku w ciągu 15-30 minut. Testy te charakteryzują się wysoką swoistością (>99%) i są szczególnie użyteczne w szybkim identyfikowaniu zakażeń u osób z objawami oraz bezobjawowych, co pozwala na natychmiastowe wdrożenie środków izolacji i ograniczenie transmisji wirusa. Czułość testów antygenowych waha się od 34,1% do 88,1%, zależnie od czasu od wystąpienia objawów i ładunku wirusa, z najwyższą skutecznością w pierwszym tygodniu choroby (do 82% u osób objawowych). W przypadku wyniku negatywnego u pacjentów z objawami zaleca się potwierdzenie testem molekularnym RT-PCR lub powtórzenie testu LFT przez 3 kolejne dni. Testy są szeroko stosowane w opiece zdrowotnej, w tym w regularnym badaniu przesiewowym personelu medycznego, domach opieki oraz opiece przedporodowej, a także w masowych programach testowania populacji.

  1. Definicja i cel szybkiego testu przepływowego na COVID-19
  2. Zasada działania testu przepływowego
    1. Interpretacja wyników
  3. Zastosowanie szybkich testów przepływowych w opiece zdrowotnej
    1. Badanie przesiewowe pracowników służby zdrowia
    2. Opieka w domach opieki i placówkach opiekuńczych
    3. Opieka przedporodowa i porody
  4. Skuteczność i ograniczenia szybkich testów przepływowych
    1. Czułość i swoistość
    2. Ograniczenia testów przepływowych
  5. Praktyczne aspekty stosowania testów przepływowych w opiece medycznej
    1. Dostępność testów dla personelu medycznego
    2. Procedura wykonania testu
    3. Interpretacja wyników i postępowanie kliniczne
  6. Zgłaszanie wyników i wymogi regulacyjne
    1. Obowiązki raportowania dla pracowników służby zdrowia
    2. Certyfikacja i kontrola jakości
  7. Najnowsze trendy i innowacje w testach przepływowych
    1. Wielokrotne zastosowania i testy kombinowane
    2. Automatyczna interpretacja wyników
    3. Testy z wykorzystaniem technologii CRISPR
  8. Rola testów przepływowych w zarządzaniu pandemią
    1. Masowe badania przesiewowe
    2. Identyfikacja bezobjawowych zakażeń
    3. Wpływ na system opieki zdrowotnej
  9. Przyszłość testów przepływowych w diagnostyce COVID-19
    1. Trendy rozwojowe i perspektywy
    2. Potencjalne zastosowania poza COVID-19
    3. Wnioski dla praktyki pielęgniarskiej
    4. Kolejne rozdziały

Definicja i cel szybkiego testu przepływowego na COVID-19

Szybki test przepływowy na COVID-19 (ang. COVID-19 rapid lateral flow test) to diagnostyczne narzędzie do samodiagnostyki, służące do wykrywania zakażenia wirusem SARS-CoV-2. Test ten jest oparty na technologii immunochromatograficznej, która umożliwia wykrycie antygenów wirusa SARS-CoV-2 lub przeciwciał skierowanych przeciwko temu wirusowi 12. Głównym celem stosowania szybkich testów przepływowych jest szybka identyfikacja potencjalnie zakaźnych osób, zarówno z objawami, jak i bez objawów klinicznych, co pozwala na natychmiastowe wdrożenie odpowiednich środków izolacji i ograniczenie transmisji wirusa 34.

Szybkie testy przepływowe charakteryzują się krótkim czasem uzyskania wyniku, który jest widoczny na urządzeniu testowym w ciągu zaledwie 15-30 minut, co stanowi znaczącą przewagę nad standardowymi testami molekularnymi RT-PCR, których wyniki są dostępne po 1-3 dniach 56. Testy przepływowe są szczególnie istotne w sytuacjach, gdy szybki czas uzyskania wyniku ma kluczowe znaczenie dla podejmowania decyzji klinicznych lub zdrowia publicznego 7.

Zasada działania testu przepływowego

Szybki test przepływowy na COVID-19 działa na zasadzie immunochromatografii. Typowy test przepływowy składa się z następujących elementów: podkładki próbkowej, podkładki koniugatowej, membrany nitrocelulozowej, podkładki absorpcyjnej, plastikowego podłoża oraz biologicznych odczynników 8. W przypadku testów antygenowych, które wykrywają białka SARS-CoV-2, proces wygląda następująco:

Próbka pobierana jest za pomocą wymazu z nosa (najczęściej z przedniej części jamy nosowej) i umieszczana w niewielkiej ilości płynu w celu zawieszenia próbki i ewentualnych cząstek wirusa. Po kilku minutach płyn ten (nazywany analitem) jest umieszczany w studzience na dole kasety testowej 9. W teście Abbott na COVID-19, przeciwciała monoklonalne przeciwko SARS-CoV-2 są unieruchomione wzdłuż paska testowego. Gdy analit przechodzi przez linię testową, wszelkie antygeny SARS-CoV-2 w analicie wiążą się z koniugowanymi przeciwciałami testowymi 10.

Na linii testowej antygeny SARS-CoV-2 działają jak pomost między unieruchomionymi przeciwciałami testowymi a przeciwciałami wizualizacyjnymi koniugowanymi ze złotem z podkładki uwalniającej koniugat. Ten wieloczęściowy kompleks zatrzymuje się w miejscu na linii testowej, a nagromadzenie koniugatów złota z przeciwciałami staje się widoczne, wskazując na wynik pozytywny 11.

Interpretacja wyników

Interpretacja wyników szybkiego testu przepływowego jest stosunkowo prosta. Wynik negatywny (ujemny) występuje, gdy widoczna jest tylko linia kontrolna (C). Oznacza to brak wykrycia antygenów specyficznych dla COVID-19 12. Wynik pozytywny (dodatni) występuje, gdy widoczna jest zarówno linia kontrolna (C), jak i linia detekcji antygenu (T). Oznacza to wykrycie antygenów specyficznych dla COVID-19 13.

Jeżeli po upływie określonego czasu na linii testowej widoczna jest jakakolwiek linia, wynik uznaje się za pozytywny. Specyficzność testów lateralnych jest ogólnie bardzo wysoka (co oznacza małe prawdopodobieństwo wyników fałszywie dodatnich) 14. W przypadku uzyskania pozytywnego wyniku, osoba badana oraz personel medyczny muszą postępować zgodnie z najnowszymi wytycznymi rządowymi dotyczącymi zgłaszania wyników, kwarantanny i samoizolacji 15.

Zastosowanie szybkich testów przepływowych w opiece zdrowotnej

Szybkie testy przepływowe odgrywają kluczową rolę w różnych aspektach opieki zdrowotnej podczas pandemii COVID-19. Ich zastosowanie jest szczególnie istotne w następujących obszarach:

Badanie przesiewowe pracowników służby zdrowia

Regularne badania przesiewowe pracowników służby zdrowia przy użyciu szybkich testów przepływowych zostały wprowadzone w wielu krajach, w tym w Wielkiej Brytanii, gdzie NHS (National Health Service) zaimplementowało program regularnego testowania pracowników opieki zdrowotnej 16. Od lipca 2021 roku wszyscy pracownicy NHS mogą zamawiać zestawy testów przepływowych LFD za pośrednictwem strony internetowej rządowej. Testy te umożliwiają regularne badanie w kierunku COVID-19 w warunkach domowych 17.

Testowanie bezobjawowych pracowników jest istotnym elementem zapobiegania i kontroli zakażeń, do którego wszystkie organizacje i pracownicy mają obowiązek się stosować. Kontynuowanie wysiłków jest niezbędne do utrzymania bezpieczeństwa pracowników i pacjentów przed potencjalną transmisją COVID-19 w placówkach opieki zdrowotnej i innych miejscach, gdzie świadczona jest opieka 18.

Zaleca się wykonywanie testów LFD dwa razy w tygodniu, co trzy do czterech dni, aby dopasować je do wzorców zmian i wymogów urlopowych, na przykład w środę i niedzielę lub w poniedziałek i czwartek 19. Wszyscy pracownicy, którzy zostali zaszczepieni, powinni nadal przeprowadzać testy, ponieważ mimo że osoby zaszczepione będą miały większą ochronę przed COVID-19 i istnieją pewne wczesne dowody na to, że szczepionka może zapobiegać zdolności danej osoby do przenoszenia wirusa, nie gwarantuje to jeszcze, że nie można przenosić wirusa na pacjentów i personel 20.

Opieka w domach opieki i placówkach opiekuńczych

Szybkie testy przepływowe są szczególnie ważne w domach opieki i innych placówkach opiekuńczych, gdzie pensjonariusze są narażeni na wysokie ryzyko ciężkiego przebiegu COVID-19. W odpowiedzi na wariant Omicron COVID-19 i rosnące obawy dotyczące transmisji i częstości występowania, rząd szkocki zalecił wykonywanie codziennych testów LFD, a także cotygodniowych testów PCR 21.

Ten krok został podjęty w celu ochrony pensjonariuszy, ponieważ dowody kliniczne sugerują, że wariant Omicron może być bardzo łatwo przenoszony między ludźmi 22. Zachęca się wszystkich pracowników opieki społecznej do wykonywania testu LFD codziennie, a szczególnie w dni, w których pracują z potencjalnie wrażliwymi osobami 23.

Pracownikom zaleca się rejestrowanie swoich wyników (zarówno pozytywnych, jak i negatywnych) na odpowiednich portalach internetowych 24. Obowiązkiem ustawowym jest zgłaszanie wszystkich wyników testów, niezależnie od tego, czy są one pozytywne, negatywne czy nieważne. Musi to nastąpić za każdym razem, gdy wykonywany jest test LFD 25.

Opieka przedporodowa i porody

Szybkie testy przepływowe znalazły również zastosowanie w opiece przedporodowej. W Hull Women and Children’s Hospital wprowadzono wymóg, aby kobiety ciężarne i ich partnerzy przeprowadzali samokontrole w kierunku COVID-19 26. Zaleca się, aby kobiety ciężarne i ich partnerzy wykonywali test dwa razy w tygodniu podczas ciąży dla własnego spokoju ducha oraz aby upewnić się, że każde zakażenie COVID-19 zostanie wcześnie wykryte i odpowiednio zarządzane 27.

W przypadku planowanych wizyt, takich jak badania USG i wizyty w klinice, kobiety powinny samodzielnie wykonać test na COVID-19 na 24 do 48 godzin przed wizytą. Dowód negatywnego wyniku testu powinien być dostarczony do kliniki przedporodowej lub na badanie USG 28. Zgodnie z krajowymi wytycznymi wszystkie szpitale będą prosić kobiety i osoby towarzyszące o przeprowadzenie testu przepływowego przed przyjściem do szpitala na rutynową opiekę przedporodową 29.

Pomoże to zidentyfikować osoby, które mogą być COVID-pozytywne i nie są tego świadome, aby można było odpowiednio zarządzać ich opieką, ale powinno również zapobiec ich przyjściu do szpitala, zmniejszając w ten sposób ryzyko przeniesienia choroby na innych 30.

Skuteczność i ograniczenia szybkich testów przepływowych

Skuteczność szybkich testów przepływowych w wykrywaniu COVID-19 była przedmiotem licznych badań naukowych. Badania te dostarczyły cennych informacji na temat czułości i swoistości tych testów w różnych scenariuszach klinicznych.

Czułość i swoistość

Badanie przeprowadzone przez naukowców z Queen Mary University of London, University of Oxford, Institute for Advanced Studies w Wiedniu i Medical University of Graz wykazało, że testy przepływowe wykrywają COVID-19 z podobną dokładnością do testów PCR wykonywanych w laboratorium, pod warunkiem że są stosowane na początku zakażenia i wkrótce po wystąpieniu objawów 31.

Testy przepływowe wykryły ponad 95% przypadków znalezionych przez PCR i prawidłowo zidentyfikowały 89% przypadków jako negatywne 32. W badaniu tym zarówno krótszy czas trwania objawów, jak i wyższy ładunek wirusa były znacząco związane z pozytywnym wynikiem testu przepływowego. Podkreśla to konieczność wykonywania testów we wczesnej fazie zakażenia za pomocą testów przepływowych i pokazuje, że u pacjentów z nowo pojawiającymi się objawami obie metody testowania mają podobny poziom dokładności 33.

Jednak w przeglądzie Cochrane wykazano, że testy antygenowe są znacznie mniej dokładne, gdy są stosowane u osób bez objawów zakażenia, ale lepiej sprawdzają się u osób, które miały kontakt z kimś, kto ma potwierdzony COVID-19 34. U osób z potwierdzonym COVID-19 testy antygenowe prawidłowo zidentyfikowały zakażenie COVID-19 średnio u 73% osób z objawami, w porównaniu do 55% osób bez objawów 35.

Testy były najbardziej dokładne, gdy były stosowane w pierwszym tygodniu po wystąpieniu objawów (średnio 82% potwierdzonych przypadków miało pozytywne testy antygenowe). W przypadku osób bez objawów testy były najbardziej dokładne u osób, które prawdopodobnie miały kontakt z przypadkiem zakażenia COVID-19 (średnio 64% potwierdzonych przypadków miało pozytywne testy antygenowe) 36.

Ograniczenia testów przepływowych

Pomimo szerokiego zastosowania i akceptowalności, szybkie testy przepływowe na COVID-19 i ścieżki opieki, w których są stosowane, mają ograniczenia, szczególnie w zakresie wyników fałszywie dodatnich i fałszywie ujemnych 37. Dokładność, a w szczególności czułość testów przepływowych, jest niższa niż referencyjnych metod RT-PCR, wahając się między 34,1% a 88,1% dla testów antygenowych SARS-CoV-2, przy ogólnej swoistości wynoszącej 99,6% 38.

Zmienna czułość testów antygenowych oznacza, że osoby, które uzyskały wynik negatywny, mogą nadal być zakażone 39. Dlatego też, jeśli wynik testu przepływowego jest negatywny, należy rozważyć możliwość fałszywych wyników negatywnych i wykonać dodatkowe testy diagnostyczne 40.

Wartość predykcyjna dodatnia (PPV) wyników jest niższa niż w istniejącej literaturze, ale należy ją rozważyć w świetle bezobjawowej populacji badanej i niskiej częstości występowania (poniżej 1%) w czasie, gdy przeprowadzano większość tych testów 41. Wyniki te sugerują, że chociaż testy przepływowe są skuteczne w identyfikacji zakażeń SARS-COV-2 o wysokim ładunku wirusowym, nie są one skuteczne w identyfikacji przypadków o niskim ładunku wirusowym 42.

Praktyczne aspekty stosowania testów przepływowych w opiece medycznej

Efektywne wdrożenie szybkich testów przepływowych w opiece medycznej wymaga uwzględnienia szeregu praktycznych aspektów, od dostępności testów po ich prawidłowe wykonanie i interpretację wyników.

Dostępność testów dla personelu medycznego

W wielu krajach testy przepływowe na COVID-19 są dostępne bezpłatnie dla pracowników służby zdrowia i opieki społecznej 43. Jesteś uprawniony do bezpłatnych testów, jeśli jesteś pracownikiem NHS mającym kontakt z pacjentami, pracownikiem świadczącym usługi NHS za pośrednictwem niezależnego świadczeniodawcy opieki zdrowotnej i mającym bezpośredni kontakt z pacjentami NHS, pracownikiem socjalnym, asystentem osobistym, opiekunem Shared Lives lub inspektorem Care Quality Commission (CQC) 44.

Jeśli pracujesz w domach opieki, opiece domicyliarnej, usługach dodatkowej opieki i wspieranego życia oraz dziennych ośrodkach opieki dla dorosłych, również możesz otrzymać bezpłatne testy NHS 45. Personel NHS może otrzymać zestaw testowy z najbliższego punktu testowego. Może być konieczne umówienie się na wizytę przed przyjściem 46.

Różne miejsca pracy i apteki mogą oferować zestawy do szybkich testów przepływowych na COVID-19. Informacje o miejscach pracy i aptekach, które mają dostępne testy, można znaleźć online 47.

Procedura wykonania testu

Szybki test przepływowy na COVID-19 jest stosunkowo prosty w wykonaniu i może być przeprowadzony przez samego pacjenta pod nadzorem lub przez wykwalifikowany personel medyczny. Procedura obejmuje następujące kroki:

  1. Pobranie wymazu z nosa (najczęściej z przedniej części jamy nosowej) za pomocą dołączonego do zestawu wymazówki.
  2. Umieszczenie wymazu w niewielkiej ilości płynu w celu zawieszenia próbki i ewentualnych cząstek wirusa.
  3. Po kilku minutach płyn ten jest umieszczany w studzience na dole kasety testowej.
  4. Odczekanie określonego czasu (zwykle 15-30 minut) na pojawienie się wyniku na urządzeniu testowym.
  5. Interpretacja wyniku na podstawie obecności lub braku linii na pasku testowym 4849.

W przypadku niektórych testów, takich jak CareStart COVID-19 Antigen Home Test, próbka pobierana jest z przedniej części jamy nosowej i test jest autoryzowany do stosowania bez recepty w warunkach domowych, z samodzielnie pobieranymi próbkami wymazu z przedniej części jamy nosowej u osób w wieku 14 lat lub starszych z objawami COVID-19 w ciągu pierwszych 7 dni od wystąpienia objawów 50.

Interpretacja wyników i postępowanie kliniczne

Prawidłowa interpretacja wyników szybkich testów przepływowych jest kluczowa dla podejmowania odpowiednich decyzji klinicznych. W przypadku uzyskania pozytywnego wyniku testu przepływowego, oznacza to, że bardzo prawdopodobne jest zakażenie COVID-19 51.

Osoby, które uzyskały wynik pozytywny w teście CareStart COVID-19 Antigen Home Test, powinny poddać się samoizolacji i poszukać opieki u swojego lekarza lub świadczeniodawcy opieki zdrowotnej, ponieważ może być konieczne dodatkowe testowanie 52. Wyniki pozytywne wskazują na obecność antygenów wirusowych, ale konieczna jest korelacja kliniczna z historią medyczną i innymi informacjami diagnostycznymi w celu określenia statusu zakażenia 53.

W przypadku wyniku negatywnego, należy go traktować jako przypuszczalny, a potwierdzenie za pomocą badania molekularnego w celu zarządzania pacjentem może być przeprowadzone w razie potrzeby 54. Osoby, które uzyskały wynik negatywny i nadal doświadczają objawów podobnych do COVID-19, takich jak gorączka, kaszel i/lub duszność, mogą nadal mieć zakażenie SARS-CoV-2 i powinny szukać dalszej opieki u swojego świadczeniodawcy opieki zdrowotnej 55.

Jeśli wynik testu jest negatywny, a pacjent kwalifikuje się do leczenia COVID-19, należy wykonać łącznie 3 szybkie testy przepływowe w ciągu 3 dni (1 test dziennie), jeśli nadal występują objawy COVID-19 56.

Zgłaszanie wyników i wymogi regulacyjne

Zgłaszanie wyników testów przepływowych jest istotnym elementem nadzoru epidemiologicznego i monitorowania przebiegu pandemii COVID-19. W wielu krajach wprowadzono wymogi regulacyjne dotyczące zgłaszania wyników testów.

Obowiązki raportowania dla pracowników służby zdrowia

W Wielkiej Brytanii nie ma obowiązku zgłaszania wyniku testu na COVID-19, chyba że jest to wymagane na mocy rozporządzenia 4A ustawy Health Protection (Notification) Regulations 2010 57. Dostawcy testów są zobowiązani do zgłaszania pozytywnych, negatywnych i nieważnych wyników testów z zastosowaniem urządzenia przepływu bocznego (LFD), gdy pomagali mieszkańcom w wykonaniu testu LFD 58.

Aby wspierać domy opieki w wypełnianiu obowiązku wynikającego z rozporządzenia 4A, arkusz wielokrotnej rejestracji UKHSA pozostanie dostępny dla placówek w celu zgłaszania wyników testów LFD na COVID-19. Możesz korzystać z tej drogi do zgłaszania wyników testów LFD, które nie zostały dostarczone bezpośrednio przez UKHSA 59. Ważne jest, aby pamiętać, że rejestracja pozytywnego testu LFD na COVID-19 nie będzie skutkować przepisaniem leczenia na COVID-19 60.

W przypadku personelu NHS wszystkie wyniki testów należy zgłaszać, niezależnie od tego, czy są one pozytywne, negatywne czy nieważne/nieprawidłowe, i dotyczy to każdego wykonanego testu. Jest to wymóg ustawowy 6162.

Certyfikacja i kontrola jakości

Szybkie testy przepływowe na COVID-19 podlegają regulacjom i procesom certyfikacji w celu zapewnienia ich jakości i skuteczności. W Stanach Zjednoczonych testy takie jak Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test są autoryzowane przez FDA w ramach Emergency Use Authorization (EUA) 63.

Test OSOM® COVID-19 Antigen Rapid Test jest ograniczony do laboratoriów certyfikowanych zgodnie z Clinical Laboratory Improvement Amendments z 1988 r. (CLIA), 42 U.S.C. § 263a, które spełniają wymagania do przeprowadzania testów o umiarkowanej, wysokiej lub odstąpionej złożoności 64. Ten test jest autoryzowany do stosowania w miejscu opieki (POC), tj. w placówkach opieki nad pacjentem działających na podstawie Certyfikatu Odstąpienia CLIA, Certyfikatu Zgodności lub Certyfikatu Akredytacji 65.

Warto zaznaczyć, że niektóre testy, takie jak OSOM® COVID-19 Antigen Rapid Test, nie zostały zatwierdzone ani autoryzowane przez FDA, ale zostały autoryzowane przez FDA w ramach EUA do stosowania przez autoryzowane laboratoria 66. Ten produkt został autoryzowany tylko do wykrywania białek SARS-CoV-2, a nie do wykrywania jakichkolwiek innych wirusów lub patogenów 67.

Najnowsze trendy i innowacje w testach przepływowych

Rozwój szybkich testów przepływowych na COVID-19 jest dynamicznym obszarem badań i innowacji. W odpowiedzi na pandemię opracowano wiele nowych technologii i udoskonaleń istniejących testów.

Wielokrotne zastosowania i testy kombinowane

Jednym z najnowszych trendów w testach przepływowych jest rozwój testów kombinowanych, które mogą jednocześnie wykrywać różne patogeny. Na przykład, Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test jest testem immunochromatograficznym przeznaczonym do jakościowego wykrywania i różnicowania antygenów białkowych SARS-CoV-2, grypy A i grypy B 68.

Test ten jest autoryzowany do stosowania bez recepty w warunkach domowych, z samodzielnie pobieranymi próbkami wymazu z przedniej części jamy nosowej u osób w wieku 14 lat lub starszych, lub z próbkami wymazu z przedniej części jamy nosowej pobieranymi przez dorosłych u osób w wieku dwóch (2) lat lub starszych 69. Test ten jest autoryzowany tylko dla osób z objawami zakażenia układu oddechowego zgodnymi z COVID-19 w ciągu pierwszych pięciu (5) dni od wystąpienia objawów, gdy testowanie jest przeprowadzane co najmniej dwa razy w ciągu trzech dni z co najmniej 48-godzinnym odstępem między testami 70.

Automatyczna interpretacja wyników

Interpretacja wyników testów diagnostycznych typu point-of-care, takich jak szybkie testy przepływowe COVID-19, może być trudna dla niewyszkolonych użytkowników. Aby rozwiązać ten problem, opracowano oprogramowanie o nazwie AutoAdapt POC, które integruje automatyczną ekstrakcję membran, uczenie się pod nadzorem i uczenie się z kilku próbek (few-shot learning) w celu automatyzacji interpretacji testów diagnostycznych POC za pomocą aparatów fotograficznych w smartfonach w skalowalny sposób 71.

AutoAdapt POC osiągnął dokładność od 99% do 100% na 726 testach (350 pozytywnych, 376 negatywnych). W badaniu drive-through COVID-19 z udziałem 74 niewyszkolonych użytkowników samodzielnie wykonujących testy, 98% uznało zbieranie obrazów za łatwe, a szybko zaadaptowane modele osiągnęły dokładność klasyfikacji na poziomie 100% zarówno dla zestawów testowych na antygen COVID-19, jak i przeciwciała 72.

Badanie to pokazuje, jak szybka adaptacja domeny w uczeniu maszynowym może zapewnić zapewnienie jakości, połączenie z opieką i śledzenie zdrowia publicznego dla niewyszkolonych użytkowników w różnorodnych testach diagnostycznych POC 73.

Testy z wykorzystaniem technologii CRISPR

Technologia CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) znalazła również zastosowanie w rozwoju szybkich testów na COVID-19. Test HybriDetect to dipstik przepływu bocznego (LFD), który jest w stanie wykrywać różne cząsteczki, w tym produkty amplifikacji genów, białka i przeciwciała 74. Wyniki można zgłaszać w ciągu 5 minut po pojawieniu się linii na pasku testowym 75.

Metoda STOP (SHERLOCK Testing in One Pot) jest udoskonaleniem poprzedniej aplikacji SHERLOCK. Ten test pozwala na czas wykonania godziny od pobrania próbki do zgłoszenia wyników. Bardzo prosta obsługa podkreśla potencjał jako testu point-of-care (POCT) do testowania COVID-19 76. Metoda została zwalidowana na 17 próbkach pacjentów. Mogła wykryć 12 pozytywnych i 5 negatywnych próbek, przy czym 2 z 3 powtórzeń zostały ocenione jako pozytywne u zakażonych pacjentów 77.

Wynalazcy STOPCovid stale udoskonalają metodę wykrywania Covid-19 do szybkiego testowania 78. Naukowcy zainteresowani testowaniem protokołu mogą uzyskać więcej informacji i zestawy testowe na stronie STOPCovid.science 79.

Rola testów przepływowych w zarządzaniu pandemią

Szybkie testy przepływowe odegrały kluczową rolę w zarządzaniu pandemią COVID-19 na różnych poziomach, od indywidualnej diagnozy po masowe programy testowania na poziomie populacji.

Masowe badania przesiewowe

Zdolność do przeprowadzania testów na COVID-19 poza placówkami medycznymi lub laboratoryjnymi, takimi jak centra drive-through lub węzły komunikacyjne, ma kluczowe znaczenie 80. Akceptowalność i wykonalność testowania na dużą skalę za pomocą testów przepływowych bocznych (LFT) do celów klinicznych i zdrowia publicznego została zademonstrowana podczas pandemii COVID-19 81.

Programy testowania COVID-19 zostały wdrożone w skali miasta (na przykład pilotażowy program testowania społeczności w Liverpoolu w Wielkiej Brytanii) oraz w skali krajowej (na przykład ogólnokrajowe testowanie na Słowacji) 82. W Anglii w ciągu mniej niż 12 miesięcy wykorzystano 20 milionów testów, wyprzedzając testy RT-PCR 83.

Mimo że są mniej dokładne niż testy PCR, niski koszt, szybkość i łatwość użycia sprawia, że testy przepływowe są szczególnie atrakcyjne dla krajów, które nie posiadają rozbudowanych obiektów laboratoryjnych ani przeszkolonych pracowników służby zdrowia, aby łatwo przeprowadzać testy PCR 84. Niektóre kraje, takie jak Słowacja i Wielka Brytania, wykorzystują testy przepływowe jako środek badania całych populacji 85.

Identyfikacja bezobjawowych zakażeń

Szybkie testy antygenowe są mniej czułe niż wirusowe NAAT, „złoty standard” w klinicznej diagnostyce COVID-19. Jednak testy antygenowe mogą być wykorzystywane do szybkiego i masowego testowania w wysokiego ryzyka środowiskach wspólnego zamieszkania w celu szybkiej identyfikacji osób z COVID-19, wdrażania środków zapobiegania i kontroli zakażeń, a tym samym zapobiegania transmisji 86.

Testy LFIA przeciwciał anty-SARS-CoV-2, IgM i/lub IgG, znane jako testy serologiczne, są stosowane do identyfikacji, czy dana osoba była wcześniej narażona na działanie wirusa lub immunizacji szczepionkowej 87. Nadzieja jest taka, że umożliwi to identyfikację większej liczby osób, które są zakażone, ale bezobjawowe, i poddanie ich kwarantannie, zmniejszając transmisję wirusa 88.

Testowanie szybkim testem lateralnym pomaga zidentyfikować potencjalnie zakaźne osoby bez objawów, zapewniając szybką identyfikację nowych zakażeń COVID-19 poprzez analizę specyficznych biomarkerów SARS-CoV-2, takich jak kwasy nukleinowe, przeciwciała i antygeny 89.

Wpływ na system opieki zdrowotnej

Testowanie przy użyciu LFT umożliwiło pracownikom służby zdrowia powrót do pracy, otwarcie szkół i miejsc pracy oraz ożywienie gospodarcze, w tym masowe zgromadzenia, testy graniczne i testy podróżne 90. WHO opracowała profil docelowego produktu dla szybkich testów antygenowych COVID-19 do stosowania w podejrzanych przypadkach COVID-19 i bliskich kontaktach, podkreślając zastosowanie LFT w obszarach, gdzie referencyjne badania molekularne są niedostępne lub gdzie czasy oczekiwania na wyniki badań molekularnych uniemożliwiają ich użyteczność 91.

Szybki rozwój profilów docelowych produktów, najpierw przez brytyjską agencję regulacyjną Medicines and Healthcare products Regulatory Agency (MHRA), a później przez WHO, zapewnił jasne oczekiwania producentom dotyczące pożądanych cech projektowych i został przyjęty z zadowoleniem przez branżę 92.

Jednak pandemia COVID-19 ujawniła ogromne nierówności w dostępie do testów, szczepionek i środków terapeutycznych 93. Filar diagnostyczny Access to COVID-19 Tools (ACT)-Accelerator (ACT-A Dx), część mechanizmu ACT-A, został ustanowiony w celu zwiększenia równego dostępu do testów COVID-19 na całym świecie 94.

Przyszłość testów przepływowych w diagnostyce COVID-19

Przyszłość szybkich testów przepływowych w diagnostyce COVID-19 i innych chorób zakaźnych wygląda obiecująco. Innowacje technologiczne i lekcje wyciągnięte z pandemii COVID-19 kształtują rozwój następnej generacji testów diagnostycznych.

Trendy rozwojowe i perspektywy

Prostota testów przepływowych wiąże się z ograniczeniami technicznymi i kompromisami użytkowymi 95. Innowacje w ultraczułych nanomateriałach, detekcji opartej na CRISPR, łączności z aplikacjami mobilnymi i głębokim uczeniu znacznie poprawiły technologię LFT 96.

Przyszła generacja testów przepływowych bocznych (LFT) będzie celować w antygeny, przeciwciała i cząsteczki, z panelami AMR (oporność na leki przeciwdrobnoustrojowe) i kodami QR (quick response), do stosowania nie tylko do samokontroli, diagnostyki klinicznej, badań przesiewowych i nadzoru, ale także do monitorowania środowiska, przy użyciu ultraczułych materiałów, takich jak nanocząstki enzymatyczne i nanodiamenty, z cyfrowym przechwytywaniem wyników 97.

Na podstawie wyników przeglądu, następna generacja LFT mogłaby zapewnić środki do szybkiego i zdecentralizowanego testowania o wysokiej czułości i swoistości na masową skalę 98.

Potencjalne zastosowania poza COVID-19

Technika LFA do wczesnej diagnozy ma duży potencjał w zapobieganiu, monitorowaniu i kontrolowaniu COVID-19, szczególnie w erze postpandemicznej 99. LFA jest potężnym środkiem do określania przeciwciał w środowisku POCT. Ostatnio szeroko raportowano wykrywanie przeciwciał na podstawie LFA dla SARS-CoV-2 100.

Pomimo tego, że obecny nacisk kładzie się na wykrywanie koronawirusa, platforma testowa mogłaby być wykorzystana również do innych celów 101. Oczekujemy, że technologia będzie szeroko przydatna w innych obszarach diagnostyki molekularnej i badań biomedycznych 102.

Okres COVID-19 przyspieszył rozwój LFT, podczas którego zgłaszano przypadki zapalenia płuc o nieznanej przyczynie w Wuhan, udostępniano informacje o sekwencjonowaniu genetycznym, a Światowa Organizacja Zdrowia (WHO) wydała tymczasowe wytyczne dotyczące stosowania szybkich testów antygenowych 103.

Wnioski dla praktyki pielęgniarskiej

Szybkie testy przepływowe na COVID-19 mają duże znaczenie w praktyce pielęgniarskiej, zapewniając szybką diagnostykę i ułatwiając podejmowanie decyzji klinicznych. Pielęgniarki powinny rozumieć zalety i ograniczenia tych testów, aby efektywnie wspierać pacjentów i zarządzać zakażeniami COVID-19.

Dla pielęgniarek i innego personelu pielęgniarskiego ważne jest regularne testowanie za pomocą testów przepływowych, aby chronić siebie, kolegów i pacjentów 104. Asympomatyczne testowanie personelu jest ważnym elementem zapobiegania i kontroli zakażeń, do którego wszystkie organizacje i personel mają obowiązek się stosować 105.

Szybkie testy przepływowe mogą być wykorzystywane w różnych środowiskach opieki pielęgniarskiej, od szpitali po domy opieki i opiekę domową. Uzyskanie dokładnej diagnozy COVID-19 za pomocą testów przepływowych umożliwia pielęgniarkom szybkie wdrożenie odpowiednich środków kontroli zakażeń, izolację zakażonych pacjentów i ochronę innych pacjentów i personelu przed potencjalnym narażeniem.

Zalety testów przepływowych Ograniczenia testów przepływowych
  • Szybki czas uzyskania wyniku (15-30 minut)
  • Możliwość wykonania testu poza laboratorium (point-of-care)
  • Niski koszt
  • Łatwość użycia
  • Możliwość masowego testowania
  • Wysoka swoistość (> 99%)
  • Niższa czułość niż testy RT-PCR (34-88%)
  • Wyższa częstość wyników fałszywie ujemnych
  • Zmienna czułość w zależności od czasu od wystąpienia objawów
  • Mniejsza dokładność u osób bezobjawowych
  • Wyniki zależne od prawidłowego wykonania testu
  • Konieczność potwierdzenia wyników negatywnych u osób objawowych

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  1. 09.04.2026
  2. www.leksykon.com.pl

Materiały źródłowe

  • #1 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. […] Lateral flow tests are cheaper and produce a result in just 30 minutes—much faster than the time it takes to receive a PCR test result, which can take one to three days. […] The lateral flow tests detected more than 95 percent of the cases found by PCR, and correctly identified 89 percent of cases as negative. […] Study author Dr. Werner Leber from Queen Mary University of London said: „Previous studies have suggested lateral flow tests may be less sensitive than PCR in detecting COVID-19, particularly among asymptomatic individuals and during the early or late stage of an infection when the viral load is lowest. But we have found that in patients who are newly symptomatic, the two testing methods have similar levels of accuracy.”
  • #2 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. […] If you work in certain healthcare settings, you may be able to get free COVID-19 rapid lateral flow tests. This will depend on your job role and if you have symptoms of COVID-19. […] COVID-19 rapid lateral flow tests show the result on the testing device within a few minutes.
  • #3 Panbio COVID-19 Ag Rapid Test Device | Abbott Point of Care
    https://www.globalpointofcare.abbott/ww/en/product-details/panbio-covid-19-ag-antigen-test-ww.html
    Identify potentially contagious people with or without symptoms in 15 minutes. […] Patient-friendly, supervised self-collected Nasal swab minimizes health worker exposure. High performance rapid test enables immediate treatment or isolation measures to minimize transmission. […] Fast identification of potentially contagious individuals. […] Test results in 15 minutes. […] Self-contained tube with „break off” swab minimizes staff exposure. […] Control swabs are used to ensure performance of the Panbio COVID-19 Ag Rapid Test Device and verify the users ability to properly perform the test and interpret the result. The Positive Control will produce positive results and has been manufactured to produce visible test line (T) and control line (C).
  • #4 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://www.mdpi.com/2075-4418/11/10/1760
    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. […] 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.
  • #5 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. […] If you work in certain healthcare settings, you may be able to get free COVID-19 rapid lateral flow tests. This will depend on your job role and if you have symptoms of COVID-19. […] COVID-19 rapid lateral flow tests show the result on the testing device within a few minutes.
  • #6 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner
    https://www.nature.com/articles/s44222-022-00007-3
    In England, 20 million tests were used in less than 12 months, outpacing RT-PCR testing. […] 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. […] Self-tests have been used in population surveillance studies, such as the Real-time Assessment of Community Transmission (REACT)-2 study in the UK, and have been widely accepted and preferred for self-testing in Europe and the USA, demonstrating safe and error-free use, as well as correct interpretation of results. […] 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 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%.
  • #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://www.mdpi.com/2075-4418/11/10/1760
    LFIA has played a critical role in COVID-19 testing due to the benefit of delivering a result in 5–30 min. It has been used for mass testing for COVID-19 globally and complement other public health measures for COVID-19. […] Antigen tests, also known as antigen-detecting rapid diagnostic tests (Ag-RDTs), are commonly used to diagnose respiratory pathogens, including influenza viruses and respiratory syncytial viruses. […] Despite the fact that antigen tests for SARS-CoV-2 are generally less sensitive than NAATs for detecting the presence of viral nucleic acid, the U.S. Food & Drug Administration (FDA) has granted emergency use authorization (EUA) for antigen tests that can identify SARS-CoV-2. […] In this case, where rapid test turnaround time is critical, there is value in providing immediate results with antigen tests, even though they may have lower sensitivity than NAATs.
  • #8 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
    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 detection of SARS-CoV-2 usually includes quantitative detection of different types of virus-specific IgG and IgM or the total level of IgG/IgM. […] LFAs are a powerful means of antibody determination in the POCT setting. Recently, antibody detection based on LFAs for SARS-CoV-2 has been widely reported. […] The purpose of antigen detection is to directly determine the viral proteins of SARS-CoV-2, such as N or S proteins. […] 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. […] A series of experiments were performed to evaluate the sensitivity and specificity of the SARS-CoV-2 antigen diagnostic test. […] Generally, antibody-based LFAs are sensitive and accurate. […] For infection monitoring and epidemiology studies, it can be a crucial tool in the post-pandemic era.
  • #9 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. […] 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.
  • #10 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. […] 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.
  • #11 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. […] 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.
  • #12 Covid-19 Antigen Rapid Lateral Flow Test Nasal Sample
    https://itstestkits.com/rapid-lateral-flow-covid-19-antigen-test/?srsltid=AfmBOop2C2hTg5js-Si1rCr-90U4kaOQLCdJnRE770Dq2mjpXsY4SXj_
    The test result is negative if only the quality control line (C) appears. This means no COVID-19 specific antigens have been detected. […] The test result is positive if the quality control line (C) and the antigen detection line (T) appears. This means COVID-19 specific antigens have been detected. […] Where this is the case, the tested individual and the healthcare provider must follow the latest government guidance on both result reporting, quarantining and self-isolation.
  • #13 Covid-19 Antigen Rapid Lateral Flow Test Nasal Sample
    https://itstestkits.com/rapid-lateral-flow-covid-19-antigen-test/?srsltid=AfmBOop2C2hTg5js-Si1rCr-90U4kaOQLCdJnRE770Dq2mjpXsY4SXj_
    The test result is negative if only the quality control line (C) appears. This means no COVID-19 specific antigens have been detected. […] The test result is positive if the quality control line (C) and the antigen detection line (T) appears. This means COVID-19 specific antigens have been detected. […] Where this is the case, the tested individual and the healthcare provider must follow the latest government guidance on both result reporting, quarantining and self-isolation.
  • #14 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.
  • #15 Covid-19 Antigen Rapid Lateral Flow Test Nasal Sample
    https://itstestkits.com/rapid-lateral-flow-covid-19-antigen-test/?srsltid=AfmBOop2C2hTg5js-Si1rCr-90U4kaOQLCdJnRE770Dq2mjpXsY4SXj_
    The test result is negative if only the quality control line (C) appears. This means no COVID-19 specific antigens have been detected. […] The test result is positive if the quality control line (C) and the antigen detection line (T) appears. This means COVID-19 specific antigens have been detected. […] Where this is the case, the tested individual and the healthcare provider must follow the latest government guidance on both result reporting, quarantining and self-isolation.
  • #16 Coronavirus » Lateral flow antigen tests for asymptomatic staff testing: frequently asked questions for – primary care (organisations and staff)
    https://www.england.nhs.uk/coronavirus/documents/lateral-flow-antigen-tests-for-asymptomatic-staff-testing-frequently-asked-questions-for-primary-care-organisations-and-staff/
    From July 2021 all NHS staff will be able to order lateral flow device (LFD) testing kits from the GOV.UK website. […] Asymptomatic staff testing is an important component of Infection Prevention and Control, which all organisations and staff have a duty to adhere to. Continued efforts are required to keep staff and patients safe from potential transmission of COVID-19 in healthcare settings, and other places where care is provided, by ensuring that all staff continue to participate in this important programme. […] From July 2021 all NHS staff will move to a new system where they will be able to order their own LFD testing kits from www.gov.uk/order-coronavirus-rapid-lateral-flow-tests. The testing kits will enable colleagues to carry out regular testing for COVID-19 at home. […] Please note, the statutory requirement to report all test results has not changed and staff must report all results in line with their organisations policy.
  • #17 Coronavirus » Lateral flow antigen tests for asymptomatic staff testing: frequently asked questions – NHS trusts (organisations and staff) including community interest companies
    https://www.england.nhs.uk/coronavirus/documents/lateral-flow-antigen-tests-for-asymptomatic-staff-testing-frequently-asked-questions-nhs-trusts-organisations-and-staff-including-community-interest-companies/
    From July 2021 all NHS staff will be able to order lateral flow device (LFD) testing kits from the GOV.UK website. […] Asymptomatic staff testing is an important component of Infection Prevention and Control, which all organisations and staff have a duty to adhere to. Continued efforts are required to keep staff and patients safe from potential transmission of COVID-19 in healthcare settings, and other places where care is provided, by ensuring that all staff continue to participate in this important programme. […] From July 2021 all NHS staff will move to a new system where they will be able to order their own LFD testing kits from. The testing kits will enable colleagues to carry out regular testing for COVID-19 at home. […] Please note, the statutory requirement to report all test results has not changed and staff must report all results in line with their organisations policy.
  • #18 Coronavirus » Lateral flow antigen tests for asymptomatic staff testing: frequently asked questions – NHS trusts (organisations and staff) including community interest companies
    https://www.england.nhs.uk/coronavirus/documents/lateral-flow-antigen-tests-for-asymptomatic-staff-testing-frequently-asked-questions-nhs-trusts-organisations-and-staff-including-community-interest-companies/
    From July 2021 all NHS staff will be able to order lateral flow device (LFD) testing kits from the GOV.UK website. […] Asymptomatic staff testing is an important component of Infection Prevention and Control, which all organisations and staff have a duty to adhere to. Continued efforts are required to keep staff and patients safe from potential transmission of COVID-19 in healthcare settings, and other places where care is provided, by ensuring that all staff continue to participate in this important programme. […] From July 2021 all NHS staff will move to a new system where they will be able to order their own LFD testing kits from. The testing kits will enable colleagues to carry out regular testing for COVID-19 at home. […] Please note, the statutory requirement to report all test results has not changed and staff must report all results in line with their organisations policy.
  • #19 Coronavirus » Lateral flow antigen tests for asymptomatic staff testing: frequently asked questions – NHS trusts (organisations and staff) including community interest companies
    https://www.england.nhs.uk/coronavirus/documents/lateral-flow-antigen-tests-for-asymptomatic-staff-testing-frequently-asked-questions-nhs-trusts-organisations-and-staff-including-community-interest-companies/
    You should carry out LFD testing twice weekly, so every three to four days to fit with shift patterns and leave requirements: for example, Wednesday and Sunday, or Monday and Thursday. […] The result, whether it is positive, negative or void/invalid, should be reported every time you complete a self-test. It is a statutory requirement to report all results. […] Yes, everyone who has been vaccinated should continue to test. Vaccinated people will have more protection from COVID-19, and there is some early evidence that it can prevent a persons ability to transmit the virus, but it does not yet guarantee that you cannot transmit the virus to patients and staff. […] Regular asymptomatic testing is voluntary, but staff should be strongly encouraged to be involved in LFD testing to protect themselves, colleagues and patients. Asymptomatic staff testing is an important component of Infection Prevention and Control, which all organisations and staff have a duty to adhere to.
  • #20 Coronavirus » Lateral flow antigen tests for asymptomatic staff testing: frequently asked questions – NHS trusts (organisations and staff) including community interest companies
    https://www.england.nhs.uk/coronavirus/documents/lateral-flow-antigen-tests-for-asymptomatic-staff-testing-frequently-asked-questions-nhs-trusts-organisations-and-staff-including-community-interest-companies/
    You should carry out LFD testing twice weekly, so every three to four days to fit with shift patterns and leave requirements: for example, Wednesday and Sunday, or Monday and Thursday. […] The result, whether it is positive, negative or void/invalid, should be reported every time you complete a self-test. It is a statutory requirement to report all results. […] Yes, everyone who has been vaccinated should continue to test. Vaccinated people will have more protection from COVID-19, and there is some early evidence that it can prevent a persons ability to transmit the virus, but it does not yet guarantee that you cannot transmit the virus to patients and staff. […] Regular asymptomatic testing is voluntary, but staff should be strongly encouraged to be involved in LFD testing to protect themselves, colleagues and patients. Asymptomatic staff testing is an important component of Infection Prevention and Control, which all organisations and staff have a duty to adhere to.
  • #21 Daily Lateral Flow and PPE Care Homes | NHS Lanarkshire
    https://www.nhslanarkshire.scot.nhs.uk/novel-corona-virus-covid-19/nhsl-staff/daily-lateral-flow-and-ppe-care-homes/
    COVID-19 Lateral Flow Device testing (LFD) […] As a matter of urgency, in response to the Omicron variant of Covid-19 and growing concerns around transmission and prevalence, we are asking you to follow the latest Scottish Government advice by carrying out an LFD test every day as well as still carrying out weekly PCR testing. […] This step is being taken to protect your residents as clinical evidence suggests the Omicron variant can be very easily transmitted between people. […] We are encouraging all social care staff to take a LFD test on a daily basis, and particularly on the days they are working with potentially vulnerable people. […] We ask that staff record their result (positive and negative) on the following portal for work based testing kits (issued from care home) Welcome COVID Testing Portal (service-now.com) and the following portal for kits collected at a pharmacy or test site Report a COVID-19 rapid lateral flow test result GOV.UK (www.gov.uk) Staff can select their profession in both portals.
  • #22 Daily Lateral Flow and PPE Care Homes | NHS Lanarkshire
    https://www.nhslanarkshire.scot.nhs.uk/novel-corona-virus-covid-19/nhsl-staff/daily-lateral-flow-and-ppe-care-homes/
    COVID-19 Lateral Flow Device testing (LFD) […] As a matter of urgency, in response to the Omicron variant of Covid-19 and growing concerns around transmission and prevalence, we are asking you to follow the latest Scottish Government advice by carrying out an LFD test every day as well as still carrying out weekly PCR testing. […] This step is being taken to protect your residents as clinical evidence suggests the Omicron variant can be very easily transmitted between people. […] We are encouraging all social care staff to take a LFD test on a daily basis, and particularly on the days they are working with potentially vulnerable people. […] We ask that staff record their result (positive and negative) on the following portal for work based testing kits (issued from care home) Welcome COVID Testing Portal (service-now.com) and the following portal for kits collected at a pharmacy or test site Report a COVID-19 rapid lateral flow test result GOV.UK (www.gov.uk) Staff can select their profession in both portals.
  • #23 Daily Lateral Flow and PPE Care Homes | NHS Lanarkshire
    https://www.nhslanarkshire.scot.nhs.uk/novel-corona-virus-covid-19/nhsl-staff/daily-lateral-flow-and-ppe-care-homes/
    COVID-19 Lateral Flow Device testing (LFD) […] As a matter of urgency, in response to the Omicron variant of Covid-19 and growing concerns around transmission and prevalence, we are asking you to follow the latest Scottish Government advice by carrying out an LFD test every day as well as still carrying out weekly PCR testing. […] This step is being taken to protect your residents as clinical evidence suggests the Omicron variant can be very easily transmitted between people. […] We are encouraging all social care staff to take a LFD test on a daily basis, and particularly on the days they are working with potentially vulnerable people. […] We ask that staff record their result (positive and negative) on the following portal for work based testing kits (issued from care home) Welcome COVID Testing Portal (service-now.com) and the following portal for kits collected at a pharmacy or test site Report a COVID-19 rapid lateral flow test result GOV.UK (www.gov.uk) Staff can select their profession in both portals.
  • #24 Daily Lateral Flow and PPE Care Homes | NHS Lanarkshire
    https://www.nhslanarkshire.scot.nhs.uk/novel-corona-virus-covid-19/nhsl-staff/daily-lateral-flow-and-ppe-care-homes/
    COVID-19 Lateral Flow Device testing (LFD) […] As a matter of urgency, in response to the Omicron variant of Covid-19 and growing concerns around transmission and prevalence, we are asking you to follow the latest Scottish Government advice by carrying out an LFD test every day as well as still carrying out weekly PCR testing. […] This step is being taken to protect your residents as clinical evidence suggests the Omicron variant can be very easily transmitted between people. […] We are encouraging all social care staff to take a LFD test on a daily basis, and particularly on the days they are working with potentially vulnerable people. […] We ask that staff record their result (positive and negative) on the following portal for work based testing kits (issued from care home) Welcome COVID Testing Portal (service-now.com) and the following portal for kits collected at a pharmacy or test site Report a COVID-19 rapid lateral flow test result GOV.UK (www.gov.uk) Staff can select their profession in both portals.
  • #25 Coronavirus » Lateral flow antigen tests for asymptomatic staff testing: frequently asked questions for – primary care (organisations and staff)
    https://www.england.nhs.uk/coronavirus/documents/lateral-flow-antigen-tests-for-asymptomatic-staff-testing-frequently-asked-questions-for-primary-care-organisations-and-staff/
    All test results must be reported whether they are positive, negative or invalid/void and this is for every test completed. Primary care employers should encourage staff members to test twice weekly and register all results (positive, negative and invalid/void) at www.gov.uk/report-covid19-result themselves. It is a statutory requirement to report results every time a self-test is completed.
  • #26 Lateral flow testing introduced for antenatal care | Hull University Teaching Hospitals NHS Trust
    https://www.hey.nhs.uk/news/2021/06/10/lateral-flow-testing-introduced-for-antenatal-care/
    People attending antenatal appointments and scans are being asked to start self-screening for Covid-19. […] Pregnant women and their birth partners are advised to carry out the test twice a week during pregnancy for their own peace of mind, and to ensure any Covid infection is picked up early and managed. […] Now from Friday 11th June, women and support partners attending antenatal appointments and scans at Hull Women and Childrens Hospital will be asked to bring proof of a negative lateral flow test with them to their appointment. […] For planned appointments such as scans and clinic appointments, women should self-administer a Covid test 24 to 48 hours before an appointment. […] Proof of a negative test result should be brought to the antenatal clinic or scan appointment. […] In line with national guidance, all hospitals will be asking women and their support person to carry out a lateral flow test before coming to hospital for routine antenatal care.
  • #27 Lateral flow testing introduced for antenatal care | Hull University Teaching Hospitals NHS Trust
    https://www.hey.nhs.uk/news/2021/06/10/lateral-flow-testing-introduced-for-antenatal-care/
    People attending antenatal appointments and scans are being asked to start self-screening for Covid-19. […] Pregnant women and their birth partners are advised to carry out the test twice a week during pregnancy for their own peace of mind, and to ensure any Covid infection is picked up early and managed. […] Now from Friday 11th June, women and support partners attending antenatal appointments and scans at Hull Women and Childrens Hospital will be asked to bring proof of a negative lateral flow test with them to their appointment. […] For planned appointments such as scans and clinic appointments, women should self-administer a Covid test 24 to 48 hours before an appointment. […] Proof of a negative test result should be brought to the antenatal clinic or scan appointment. […] In line with national guidance, all hospitals will be asking women and their support person to carry out a lateral flow test before coming to hospital for routine antenatal care.
  • #28 Lateral flow testing introduced for antenatal care | Hull University Teaching Hospitals NHS Trust
    https://www.hey.nhs.uk/news/2021/06/10/lateral-flow-testing-introduced-for-antenatal-care/
    People attending antenatal appointments and scans are being asked to start self-screening for Covid-19. […] Pregnant women and their birth partners are advised to carry out the test twice a week during pregnancy for their own peace of mind, and to ensure any Covid infection is picked up early and managed. […] Now from Friday 11th June, women and support partners attending antenatal appointments and scans at Hull Women and Childrens Hospital will be asked to bring proof of a negative lateral flow test with them to their appointment. […] For planned appointments such as scans and clinic appointments, women should self-administer a Covid test 24 to 48 hours before an appointment. […] Proof of a negative test result should be brought to the antenatal clinic or scan appointment. […] In line with national guidance, all hospitals will be asking women and their support person to carry out a lateral flow test before coming to hospital for routine antenatal care.
  • #29 Lateral flow testing introduced for antenatal care | Hull University Teaching Hospitals NHS Trust
    https://www.hey.nhs.uk/news/2021/06/10/lateral-flow-testing-introduced-for-antenatal-care/
    People attending antenatal appointments and scans are being asked to start self-screening for Covid-19. […] Pregnant women and their birth partners are advised to carry out the test twice a week during pregnancy for their own peace of mind, and to ensure any Covid infection is picked up early and managed. […] Now from Friday 11th June, women and support partners attending antenatal appointments and scans at Hull Women and Childrens Hospital will be asked to bring proof of a negative lateral flow test with them to their appointment. […] For planned appointments such as scans and clinic appointments, women should self-administer a Covid test 24 to 48 hours before an appointment. […] Proof of a negative test result should be brought to the antenatal clinic or scan appointment. […] In line with national guidance, all hospitals will be asking women and their support person to carry out a lateral flow test before coming to hospital for routine antenatal care.
  • #30 Lateral flow testing introduced for antenatal care | Hull University Teaching Hospitals NHS Trust
    https://www.hey.nhs.uk/news/2021/06/10/lateral-flow-testing-introduced-for-antenatal-care/
    This will help us identify people who may be Covid positive and unaware of it, so that we can manage their care appropriately, but it should also prevent them attending hospital and so reduce the risk of transmission to others. […] Completing a quick lateral flow test just prior to the appointment date is an easy way to show you care and reduce the risk for everyone.
  • #31 Lateral flow tests are 95% effective at detecting Covid-19 when used at the onset of symptoms | University of Oxford
    https://www.ox.ac.uk/news/2021-07-14-lateral-flow-tests-are-95-effective-detecting-covid-19-when-used-onset-symptoms
    Lateral flow tests are 95% effective at detecting Covid-19 when used at the onset of symptoms. […] 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 per cent of the cases found by PCR, and correctly identified 89 per cent of cases as negative. […] In our study, both shorter duration of symptoms and higher viral load were significantly associated with a positive lateral flow tests. This highlights the necessity of testing at early infection with lateral flow tests, and shows that in patients who are newly symptomatic, the two testing methods have similar levels of accuracy. […] 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.
  • #32 Lateral flow tests are 95% effective at detecting Covid-19 when used at the onset of symptoms | University of Oxford
    https://www.ox.ac.uk/news/2021-07-14-lateral-flow-tests-are-95-effective-detecting-covid-19-when-used-onset-symptoms
    Lateral flow tests are 95% effective at detecting Covid-19 when used at the onset of symptoms. […] 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 per cent of the cases found by PCR, and correctly identified 89 per cent of cases as negative. […] In our study, both shorter duration of symptoms and higher viral load were significantly associated with a positive lateral flow tests. This highlights the necessity of testing at early infection with lateral flow tests, and shows that in patients who are newly symptomatic, the two testing methods have similar levels of accuracy. […] 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.
  • #33 Lateral flow tests are 95% effective at detecting Covid-19 when used at the onset of symptoms | University of Oxford
    https://www.ox.ac.uk/news/2021-07-14-lateral-flow-tests-are-95-effective-detecting-covid-19-when-used-onset-symptoms
    Lateral flow tests are 95% effective at detecting Covid-19 when used at the onset of symptoms. […] 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 per cent of the cases found by PCR, and correctly identified 89 per cent of cases as negative. […] In our study, both shorter duration of symptoms and higher viral load were significantly associated with a positive lateral flow tests. This highlights the necessity of testing at early infection with lateral flow tests, and shows that in patients who are newly symptomatic, the two testing methods have similar levels of accuracy. […] 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.
  • #34 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 many places, rapid antigen tests have opened access to testing for many more people, with and without symptoms, and in locations other than healthcare settings. […] 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.
  • #35 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 many places, rapid antigen tests have opened access to testing for many more people, with and without symptoms, and in locations other than healthcare settings. […] 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.
  • #36 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 many places, rapid antigen tests have opened access to testing for many more people, with and without symptoms, and in locations other than healthcare settings. […] 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.
  • #37 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner
    https://www.nature.com/articles/s44222-022-00007-3
    In England, 20 million tests were used in less than 12 months, outpacing RT-PCR testing. […] 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. […] Self-tests have been used in population surveillance studies, such as the Real-time Assessment of Community Transmission (REACT)-2 study in the UK, and have been widely accepted and preferred for self-testing in Europe and the USA, demonstrating safe and error-free use, as well as correct interpretation of results. […] 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 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%.
  • #38 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner
    https://www.nature.com/articles/s44222-022-00007-3
    In England, 20 million tests were used in less than 12 months, outpacing RT-PCR testing. […] 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. […] Self-tests have been used in population surveillance studies, such as the Real-time Assessment of Community Transmission (REACT)-2 study in the UK, and have been widely accepted and preferred for self-testing in Europe and the USA, demonstrating safe and error-free use, as well as correct interpretation of results. […] 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 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%.
  • #39 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
    Different brands of tests varied in accuracy. […] No test met this standard when evaluated in people without symptoms. […] 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 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. […] The variable sensitivity of antigen tests means that people who test negative may still be infected. […] Many commercially available rapid antigen tests have not been evaluated in independent validation studies.
  • #40 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. […] 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. […] 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.
  • #41 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. […] 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. […] 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.
  • #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. […] 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. […] 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.
  • #43 How do I get free home rapid lateral flow test kits?
    https://bwc.nhs.uk/how-do-i-get-free-home-rapid-lateral-flow-test-kits/
    Free testing for coronavirus (COVID-19) from the NHS has ended for most people in England. […] You may need to get tested if you’re due to have surgery or a procedure. […] You are eligible for free tests if you’re: NHS patient-facing staff, staff who deliver NHS services through an independent healthcare provider, and have direct contact with NHS patients, a social worker, a personal assistant, a Shared Lives carer, a Care Quality Commission (CQC) inspector. […] If you work in care homes, domiciliary care, extra care and supported living services, and adult day care centres, you can also get free NHS tests.
  • #44 How do I get free home rapid lateral flow test kits?
    https://bwc.nhs.uk/how-do-i-get-free-home-rapid-lateral-flow-test-kits/
    Free testing for coronavirus (COVID-19) from the NHS has ended for most people in England. […] You may need to get tested if you’re due to have surgery or a procedure. […] You are eligible for free tests if you’re: NHS patient-facing staff, staff who deliver NHS services through an independent healthcare provider, and have direct contact with NHS patients, a social worker, a personal assistant, a Shared Lives carer, a Care Quality Commission (CQC) inspector. […] If you work in care homes, domiciliary care, extra care and supported living services, and adult day care centres, you can also get free NHS tests.
  • #45 How do I get free home rapid lateral flow test kits?
    https://bwc.nhs.uk/how-do-i-get-free-home-rapid-lateral-flow-test-kits/
    Free testing for coronavirus (COVID-19) from the NHS has ended for most people in England. […] You may need to get tested if you’re due to have surgery or a procedure. […] You are eligible for free tests if you’re: NHS patient-facing staff, staff who deliver NHS services through an independent healthcare provider, and have direct contact with NHS patients, a social worker, a personal assistant, a Shared Lives carer, a Care Quality Commission (CQC) inspector. […] If you work in care homes, domiciliary care, extra care and supported living services, and adult day care centres, you can also get free NHS tests.
  • #46 COVID-19 Rapid Lateral Flow Testing | Mayfair Specialist Nursing
    https://mayfair-nurses.co.uk/news/covid-19-rapid-lateral-flow-testing
    COVID-19 Rapid Lateral Flow Tests for Healthcare Workers […] All healthcare workers are required to apply for their COVID-19 lateral flow testing kits. Use this service to order free packs of rapid lateral flow tests to be sent to your home. Testing kits will no longer be supplied by the organisation Herefordshire and Worcestershire Health and Care trust. […] It is a statutory duty that all test results must be reported, whether they are positive, negative or invalid/void. This must happen every time an LFD test is completed. […] When staff receive their box of tests, if any of the items supplied are missing, broken, or if the device is damaged or breaks during use, if the user of the test has any concerns about the performance of the test, or if any adverse incident with the test occurs, then these incidents should be reported. Users should report this information directly to the Medicines and Healthcare products Regulatory Agency (MHRA) via their reporting portal: coronavirus-yellowcard.mhra.gov.uk. […] NHS staff can get their testing kit from their nearest test site. You may have to make an appointment before going. […] Various Workplaces and pharmacies might offer COVID-19 rapid flow test kits. Find out which workplaces and pharmacies have the test available online.
  • #47 COVID-19 Rapid Lateral Flow Testing | Mayfair Specialist Nursing
    https://mayfair-nurses.co.uk/news/covid-19-rapid-lateral-flow-testing
    COVID-19 Rapid Lateral Flow Tests for Healthcare Workers […] All healthcare workers are required to apply for their COVID-19 lateral flow testing kits. Use this service to order free packs of rapid lateral flow tests to be sent to your home. Testing kits will no longer be supplied by the organisation Herefordshire and Worcestershire Health and Care trust. […] It is a statutory duty that all test results must be reported, whether they are positive, negative or invalid/void. This must happen every time an LFD test is completed. […] When staff receive their box of tests, if any of the items supplied are missing, broken, or if the device is damaged or breaks during use, if the user of the test has any concerns about the performance of the test, or if any adverse incident with the test occurs, then these incidents should be reported. Users should report this information directly to the Medicines and Healthcare products Regulatory Agency (MHRA) via their reporting portal: coronavirus-yellowcard.mhra.gov.uk. […] NHS staff can get their testing kit from their nearest test site. You may have to make an appointment before going. […] Various Workplaces and pharmacies might offer COVID-19 rapid flow test kits. Find out which workplaces and pharmacies have the test available online.
  • #48 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. […] 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.
  • #49 Rapid Antigen Test vs Lateral Flow Test for Covid-19 | Nomad Health
    https://www.nomadtravel.co.uk/blog/travel-health/rapid-antigen-test-vs-lateral-flow
    The rapid lateral flow test kit includes a hand-held device with an absorbent pad at one end and a reading window at the other. The user applies a swab sample to the absorbent pad on the device. The device contains is a strip of test paper that changes colour in the presence of COVID-19 antigens. Your test will be complete within 20 minutes, with easy to interpret results that don’t require laboratory processing. […] Nomad offer several rapid lateral flow test options that cost from 15. We offer both at-home self testing kits (15 18) and in-clinic testing (39) undertaken by a Nomad clinician.
  • #50 CareStart™ COVID-19 Antigen Home Test – Access Bio
    https://accessbio.net/products/covid-19-detection-kits/carestart-covid-19-antigen-home-test
    The CareStart COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2. […] This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. […] Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. […] Individuals who test positive with the CareStart COVID-19 Antigen Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary. […] Negative results should be treated as presumptive and confirmation with a molecular assay for patient management, may be performed if necessary.
  • #51 How reliable are lateral flow COVID-19 tests? – The Pharmaceutical Journal
    https://pharmaceutical-journal.com/article/feature/how-reliable-are-lateral-flow-covid-19-tests
    We take a look at whether the widely used lateral flow tests help detect COVID-19, and the evidence for their accuracy. […] The benefit of lateral flow tests is that most tests generate easy-to-understand results in under half an hour and can be used at the point of care rather than sent to a lab to process. […] If you get a positive result from a lateral flow test, it is extremely likely you are currently infected with COVID-19 and risk infecting others. […] The MHRA has stated that “no test is 100% reliable”, even those that meet regulatory standards for performance and safety. […] Therefore, it has emphasised that lateral flow tests are only authorised to be used as a “red light” test in order to find infectious people and ensure they self-isolate quickly, and not as a “green light” for people who test negative to enjoy greater freedoms.
  • #52 CareStart™ COVID-19 Antigen Home Test – Access Bio
    https://accessbio.net/products/covid-19-detection-kits/carestart-covid-19-antigen-home-test
    The CareStart COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2. […] This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. […] Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. […] Individuals who test positive with the CareStart COVID-19 Antigen Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary. […] Negative results should be treated as presumptive and confirmation with a molecular assay for patient management, may be performed if necessary.
  • #53 CareStart™ COVID-19 Antigen Home Test – Access Bio
    https://accessbio.net/products/covid-19-detection-kits/carestart-covid-19-antigen-home-test
    The CareStart COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2. […] This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. […] Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. […] Individuals who test positive with the CareStart COVID-19 Antigen Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary. […] Negative results should be treated as presumptive and confirmation with a molecular assay for patient management, may be performed if necessary.
  • #54 CareStart™ COVID-19 Antigen Home Test – Access Bio
    https://accessbio.net/products/covid-19-detection-kits/carestart-covid-19-antigen-home-test
    The CareStart COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2. […] This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. […] Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. […] Individuals who test positive with the CareStart COVID-19 Antigen Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary. […] Negative results should be treated as presumptive and confirmation with a molecular assay for patient management, may be performed if necessary.
  • #55 CareStart™ COVID-19 Antigen Home Test – Access Bio
    https://accessbio.net/products/covid-19-detection-kits/carestart-covid-19-antigen-home-test
    Individuals who test negative and continue to experience COVID-like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care from their healthcare provider. […] The CareStart COVID-19 Antigen Home Test is authorized for non-prescription self-use and/or, as applicable for an adult lay user testing another person aged 2 years or older.
  • #56 COVID-19 testing – NHS
    https://www.nhs.uk/conditions/covid-19-rapid-lateral-flow-test/
    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 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.
  • #57
    https://www.gov.uk/guidance/covid-19-self-test-help
    Find out how to do a rapid lateral flow test for COVID-19. Rapid lateral flow tests show the result on a device that comes with the test. […] You do not need to report a COVID-19 test result unless you are required to do so under Regulation 4A of the Health Protection (Notification) Regulations 2010. Test providers are required to report positive, negative and void lateral flow device (LFD) test results where they have assisted residents to take an LFD test. […] To support care homes in being able to meet their Regulation 4A duty, UKHSAs multiple registration spreadsheet will remain available for settings to report COVID-19 LFD test results. You are able to use this route to report the results of LFD tests that have not been provided to you directly by UKHSA. […] It is important to note the registration of a positive COVID-19 LFD test will not result in the prescribing of a COVID-19 treatment. […] If any part of your test kit is damaged or missing, do not use that test kit. You can still use the other tests in the pack. […] If you’ve been harmed or had a reaction using the test kit, report it as soon as possible.
  • #58
    https://www.gov.uk/guidance/covid-19-self-test-help
    Find out how to do a rapid lateral flow test for COVID-19. Rapid lateral flow tests show the result on a device that comes with the test. […] You do not need to report a COVID-19 test result unless you are required to do so under Regulation 4A of the Health Protection (Notification) Regulations 2010. Test providers are required to report positive, negative and void lateral flow device (LFD) test results where they have assisted residents to take an LFD test. […] To support care homes in being able to meet their Regulation 4A duty, UKHSAs multiple registration spreadsheet will remain available for settings to report COVID-19 LFD test results. You are able to use this route to report the results of LFD tests that have not been provided to you directly by UKHSA. […] It is important to note the registration of a positive COVID-19 LFD test will not result in the prescribing of a COVID-19 treatment. […] If any part of your test kit is damaged or missing, do not use that test kit. You can still use the other tests in the pack. […] If you’ve been harmed or had a reaction using the test kit, report it as soon as possible.
  • #59
    https://www.gov.uk/guidance/covid-19-self-test-help
    Find out how to do a rapid lateral flow test for COVID-19. Rapid lateral flow tests show the result on a device that comes with the test. […] You do not need to report a COVID-19 test result unless you are required to do so under Regulation 4A of the Health Protection (Notification) Regulations 2010. Test providers are required to report positive, negative and void lateral flow device (LFD) test results where they have assisted residents to take an LFD test. […] To support care homes in being able to meet their Regulation 4A duty, UKHSAs multiple registration spreadsheet will remain available for settings to report COVID-19 LFD test results. You are able to use this route to report the results of LFD tests that have not been provided to you directly by UKHSA. […] It is important to note the registration of a positive COVID-19 LFD test will not result in the prescribing of a COVID-19 treatment. […] If any part of your test kit is damaged or missing, do not use that test kit. You can still use the other tests in the pack. […] If you’ve been harmed or had a reaction using the test kit, report it as soon as possible.
  • #60
    https://www.gov.uk/guidance/covid-19-self-test-help
    Find out how to do a rapid lateral flow test for COVID-19. Rapid lateral flow tests show the result on a device that comes with the test. […] You do not need to report a COVID-19 test result unless you are required to do so under Regulation 4A of the Health Protection (Notification) Regulations 2010. Test providers are required to report positive, negative and void lateral flow device (LFD) test results where they have assisted residents to take an LFD test. […] To support care homes in being able to meet their Regulation 4A duty, UKHSAs multiple registration spreadsheet will remain available for settings to report COVID-19 LFD test results. You are able to use this route to report the results of LFD tests that have not been provided to you directly by UKHSA. […] It is important to note the registration of a positive COVID-19 LFD test will not result in the prescribing of a COVID-19 treatment. […] If any part of your test kit is damaged or missing, do not use that test kit. You can still use the other tests in the pack. […] If you’ve been harmed or had a reaction using the test kit, report it as soon as possible.
  • #61 Coronavirus » Lateral flow antigen tests for asymptomatic staff testing: frequently asked questions for – primary care (organisations and staff)
    https://www.england.nhs.uk/coronavirus/documents/lateral-flow-antigen-tests-for-asymptomatic-staff-testing-frequently-asked-questions-for-primary-care-organisations-and-staff/
    All test results must be reported whether they are positive, negative or invalid/void and this is for every test completed. Primary care employers should encourage staff members to test twice weekly and register all results (positive, negative and invalid/void) at www.gov.uk/report-covid19-result themselves. It is a statutory requirement to report results every time a self-test is completed.
  • #62 Coronavirus » Lateral flow antigen tests for asymptomatic staff testing: frequently asked questions – NHS trusts (organisations and staff) including community interest companies
    https://www.england.nhs.uk/coronavirus/documents/lateral-flow-antigen-tests-for-asymptomatic-staff-testing-frequently-asked-questions-nhs-trusts-organisations-and-staff-including-community-interest-companies/
    You should carry out LFD testing twice weekly, so every three to four days to fit with shift patterns and leave requirements: for example, Wednesday and Sunday, or Monday and Thursday. […] The result, whether it is positive, negative or void/invalid, should be reported every time you complete a self-test. It is a statutory requirement to report all results. […] Yes, everyone who has been vaccinated should continue to test. Vaccinated people will have more protection from COVID-19, and there is some early evidence that it can prevent a persons ability to transmit the virus, but it does not yet guarantee that you cannot transmit the virus to patients and staff. […] Regular asymptomatic testing is voluntary, but staff should be strongly encouraged to be involved in LFD testing to protect themselves, colleagues and patients. Asymptomatic staff testing is an important component of Infection Prevention and Control, which all organisations and staff have a duty to adhere to.
  • #63 Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test
    https://www.cardinalhealth.com/en/cmp/ext/med/med-lab/speedy-swab-rapid-covid-19-flu-test.html
    Test type: Lateral flow assay Specimen type: Anterior nasal swab specimens Turnaround time: 15 minutes CLIA complexity: OTC. […] This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA; […] The emergency use of this product is 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.
  • #64 OSOM® COVID-19 Antigen Rapid Test
    https://www.cardinalhealth.com/en/cmp/ext/med/med-lab/osom-covid-19-antigen-rapid-test.html
    OSOM® COVID-19 Antigen Rapid Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in direct mid-turbinate (MT) nasal swab specimens collected by a healthcare provider from individuals suspected of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests and from 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. […] Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet the requirements to perform moderate, high or waived complexity tests.
  • #65 OSOM® COVID-19 Antigen Rapid Test
    https://www.cardinalhealth.com/en/cmp/ext/med/med-lab/osom-covid-19-antigen-rapid-test.html
    This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. […] Test type: Lateral flow chromatographic immunoassay […] Specimen type: Direct mid-turbinate (MT) nasal swab specimens […] Turnaround time: 15-30 minutes […] CLIA complexity: Waived […] FDA Status: Emergency Use Authorization (EUA) granted […] This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories; […] This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, […] The emergency use of this product is 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.
  • #66 OSOM® COVID-19 Antigen Rapid Test
    https://www.cardinalhealth.com/en/cmp/ext/med/med-lab/osom-covid-19-antigen-rapid-test.html
    This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. […] Test type: Lateral flow chromatographic immunoassay […] Specimen type: Direct mid-turbinate (MT) nasal swab specimens […] Turnaround time: 15-30 minutes […] CLIA complexity: Waived […] FDA Status: Emergency Use Authorization (EUA) granted […] This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories; […] This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, […] The emergency use of this product is 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.
  • #67 OSOM® COVID-19 Antigen Rapid Test
    https://www.cardinalhealth.com/en/cmp/ext/med/med-lab/osom-covid-19-antigen-rapid-test.html
    This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. […] Test type: Lateral flow chromatographic immunoassay […] Specimen type: Direct mid-turbinate (MT) nasal swab specimens […] Turnaround time: 15-30 minutes […] CLIA complexity: Waived […] FDA Status: Emergency Use Authorization (EUA) granted […] This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories; […] This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, […] The emergency use of this product is 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.
  • #68 Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test
    https://www.cardinalhealth.com/en/cmp/ext/med/med-lab/speedy-swab-rapid-covid-19-flu-test.html
    The Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens. […] This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older. […] This test is only authorized for individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests. […] Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.
  • #69 Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test
    https://www.cardinalhealth.com/en/cmp/ext/med/med-lab/speedy-swab-rapid-covid-19-flu-test.html
    The Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens. […] This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older. […] This test is only authorized for individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests. […] Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.
  • #70 Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test
    https://www.cardinalhealth.com/en/cmp/ext/med/med-lab/speedy-swab-rapid-covid-19-flu-test.html
    The Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens. […] This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older. […] This test is only authorized for individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests. […] Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.
  • #71 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. However, efforts to ensure correct assay operation and result interpretation rely on hardware that cannot be easily scaled or image processing approaches requiring large training datasets, necessitating large numbers of tests and expert labeling with validated specimens for every new test kit format. […] 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. […] It can be difficult to correctly interpret the results of rapid diagnostic tests that give a visual readout, such as COVID rapid tests. We developed a computational algorithm to interpret rapid test results using an image taken by a smartphone camera. 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. […] A large and diverse number of POC diagnostics, including lateral-flow assays (LFAs), are becoming widely used by the public and endorsed by policymakers, but to ensure patient safety and enable public health monitoring, assurance of correct assay operation and interpretation of results—two standardized quality-controlled processes for diagnostic tests in a centralized laboratory—are critical but not currently performed in decentralized settings. […] 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, and the FDA requiring rapid test makers to “facilitate results reporting by both the healthcare provider and the individual.” […] 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. […] Here, we demonstrate an approach that can rapidly adapt to interpreting new POC diagnostic tests, such that large, diverse, and dynamic sets of rapid tests can be interpreted accurately without extensive procurement of specific test kits, validated specimens, and experts for labeling. […] 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 automated and modular analysis of bands (instead of entire test kits), along with encoding and decoding of edge-filtered images for self-supervised learning, are crucial to the universality and accuracy of the approach. […] 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.
  • #72 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. However, efforts to ensure correct assay operation and result interpretation rely on hardware that cannot be easily scaled or image processing approaches requiring large training datasets, necessitating large numbers of tests and expert labeling with validated specimens for every new test kit format. […] 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. […] It can be difficult to correctly interpret the results of rapid diagnostic tests that give a visual readout, such as COVID rapid tests. We developed a computational algorithm to interpret rapid test results using an image taken by a smartphone camera. 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. […] A large and diverse number of POC diagnostics, including lateral-flow assays (LFAs), are becoming widely used by the public and endorsed by policymakers, but to ensure patient safety and enable public health monitoring, assurance of correct assay operation and interpretation of results—two standardized quality-controlled processes for diagnostic tests in a centralized laboratory—are critical but not currently performed in decentralized settings. […] 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, and the FDA requiring rapid test makers to “facilitate results reporting by both the healthcare provider and the individual.” […] 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. […] Here, we demonstrate an approach that can rapidly adapt to interpreting new POC diagnostic tests, such that large, diverse, and dynamic sets of rapid tests can be interpreted accurately without extensive procurement of specific test kits, validated specimens, and experts for labeling. […] 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 automated and modular analysis of bands (instead of entire test kits), along with encoding and decoding of edge-filtered images for self-supervised learning, are crucial to the universality and accuracy of the approach. […] 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.
  • #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. However, efforts to ensure correct assay operation and result interpretation rely on hardware that cannot be easily scaled or image processing approaches requiring large training datasets, necessitating large numbers of tests and expert labeling with validated specimens for every new test kit format. […] 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. […] It can be difficult to correctly interpret the results of rapid diagnostic tests that give a visual readout, such as COVID rapid tests. We developed a computational algorithm to interpret rapid test results using an image taken by a smartphone camera. 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. […] A large and diverse number of POC diagnostics, including lateral-flow assays (LFAs), are becoming widely used by the public and endorsed by policymakers, but to ensure patient safety and enable public health monitoring, assurance of correct assay operation and interpretation of results—two standardized quality-controlled processes for diagnostic tests in a centralized laboratory—are critical but not currently performed in decentralized settings. […] 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, and the FDA requiring rapid test makers to “facilitate results reporting by both the healthcare provider and the individual.” […] 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. […] Here, we demonstrate an approach that can rapidly adapt to interpreting new POC diagnostic tests, such that large, diverse, and dynamic sets of rapid tests can be interpreted accurately without extensive procurement of specific test kits, validated specimens, and experts for labeling. […] 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 automated and modular analysis of bands (instead of entire test kits), along with encoding and decoding of edge-filtered images for self-supervised learning, are crucial to the universality and accuracy of the approach. […] 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.
  • #74 COVID-19 rapid test using CRISPR & HybriDetect
    https://www.milenia-biotec.com/en/covid-19-rapid-test-development/
    The HybriDetect is a lateral flow dipstick (LFD), which is capable to detect different molecules, including gene amplification products, proteins and antibodies. […] Results can be reported within 5 minutes after lines become visible on the test strip. […] With the currently available rapid Antigen tests, a result is available after 15 minutes outside the lab. But the Antigen tests are detecting viral proteins, and are therefore less sensitive as a test on DNA level. […] The so-called STOP (S HERLOCK T esting in O ne P ot) 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.
  • #75 COVID-19 rapid test using CRISPR & HybriDetect
    https://www.milenia-biotec.com/en/covid-19-rapid-test-development/
    The HybriDetect is a lateral flow dipstick (LFD), which is capable to detect different molecules, including gene amplification products, proteins and antibodies. […] Results can be reported within 5 minutes after lines become visible on the test strip. […] With the currently available rapid Antigen tests, a result is available after 15 minutes outside the lab. But the Antigen tests are detecting viral proteins, and are therefore less sensitive as a test on DNA level. […] The so-called STOP (S HERLOCK T esting in O ne P ot) 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.
  • #76 COVID-19 rapid test using CRISPR & HybriDetect
    https://www.milenia-biotec.com/en/covid-19-rapid-test-development/
    The HybriDetect is a lateral flow dipstick (LFD), which is capable to detect different molecules, including gene amplification products, proteins and antibodies. […] Results can be reported within 5 minutes after lines become visible on the test strip. […] With the currently available rapid Antigen tests, a result is available after 15 minutes outside the lab. But the Antigen tests are detecting viral proteins, and are therefore less sensitive as a test on DNA level. […] The so-called STOP (S HERLOCK T esting in O ne P ot) 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.
  • #77 COVID-19 rapid test using CRISPR & HybriDetect
    https://www.milenia-biotec.com/en/covid-19-rapid-test-development/
    The HybriDetect is a lateral flow dipstick (LFD), which is capable to detect different molecules, including gene amplification products, proteins and antibodies. […] Results can be reported within 5 minutes after lines become visible on the test strip. […] With the currently available rapid Antigen tests, a result is available after 15 minutes outside the lab. But the Antigen tests are detecting viral proteins, and are therefore less sensitive as a test on DNA level. […] The so-called STOP (S HERLOCK T esting in O ne P ot) 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.
  • #78 COVID-19 rapid test using CRISPR & HybriDetect
    https://www.milenia-biotec.com/en/covid-19-rapid-test-development/
    The inventors of STOPCovid are constantly improving the Covid-19 detection method for rapid testing. […] Scientists who are interested in testing the protocol can get more information and test kits at STOPCovid.science. […] Broughton et al. already published a paper, how to detect SARS_CoV-2 using LAMP, Cas12 and our HybriDetect within 30 minutes. […] In summary, rapid testing is being expanded to stop the spread of Covid 19. 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.
  • #79 COVID-19 rapid test using CRISPR & HybriDetect
    https://www.milenia-biotec.com/en/covid-19-rapid-test-development/
    The inventors of STOPCovid are constantly improving the Covid-19 detection method for rapid testing. […] Scientists who are interested in testing the protocol can get more information and test kits at STOPCovid.science. […] Broughton et al. already published a paper, how to detect SARS_CoV-2 using LAMP, Cas12 and our HybriDetect within 30 minutes. […] In summary, rapid testing is being expanded to stop the spread of Covid 19. 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.
  • #80 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
    Countries around the world require accurate Covid-19 testing, in order to keep their citizens safe and protect economies. […] Lateral flow-based diagnostics can address some of these drawbacks, thanks to their rapid results, relatively low cost and portability. […] 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 robust nature of the diagnostic platform would make it ideal for use in ambulances or the emergency room, quickly diagnosing heart attacks and allowing for earlier intervention when needed. […] 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, but Brightline DX is looking to explore further.
  • #81 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. […] Professional use and self-tests have enabled LFT-based testing to be expanded beyond healthcare facilities and into community settings and homes. […] 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).
  • #82 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. […] Professional use and self-tests have enabled LFT-based testing to be expanded beyond healthcare facilities and into community settings and homes. […] 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).
  • #83 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner
    https://www.nature.com/articles/s44222-022-00007-3
    In England, 20 million tests were used in less than 12 months, outpacing RT-PCR testing. […] 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. […] Self-tests have been used in population surveillance studies, such as the Real-time Assessment of Community Transmission (REACT)-2 study in the UK, and have been widely accepted and preferred for self-testing in Europe and the USA, demonstrating safe and error-free use, as well as correct interpretation of results. […] 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 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%.
  • #84 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
    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. […] Some countries, such as Slovakia and the UK are using lateral flow tests as a means of screening whole populations. […] The hope is that this will enable more people who are infected, but asymptomatic, to be identified and quarantined, reducing transmission of the virus.
  • #85 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
    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. […] Some countries, such as Slovakia and the UK are using lateral flow tests as a means of screening whole populations. […] The hope is that this will enable more people who are infected, but asymptomatic, to be identified and quarantined, reducing transmission of the virus.
  • #86 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. […] Opportune detection, confinement, and early treatment of infected cases present the first step in combating COVID-19. […] 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. […] 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. […] 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.
  • #87 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. […] Opportune detection, confinement, and early treatment of infected cases present the first step in combating COVID-19. […] 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. […] 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. […] 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.
  • #88 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
    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. […] Some countries, such as Slovakia and the UK are using lateral flow tests as a means of screening whole populations. […] The hope is that this will enable more people who are infected, but asymptomatic, to be identified and quarantined, reducing transmission of the virus.
  • #89 Point-of-care COVID-19 diagnostics powered by lateral flow assay – PMC Lock
    https://pmc.ncbi.nlm.nih.gov/articles/PMC8487324/
    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. […] 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.
  • #90 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner
    https://www.nature.com/articles/s44222-022-00007-3
    LFT testing has enabled healthcare workers to return to work, schools and workplaces to reopen, and economic recovery, including mass gatherings, border testing and travel testing. […] 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. […] 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 COVID-19 pandemic has revealed enormous inequities in access to tests, vaccines and therapeutics.
  • #91 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner
    https://www.nature.com/articles/s44222-022-00007-3
    LFT testing has enabled healthcare workers to return to work, schools and workplaces to reopen, and economic recovery, including mass gatherings, border testing and travel testing. […] 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. […] 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 COVID-19 pandemic has revealed enormous inequities in access to tests, vaccines and therapeutics.
  • #92 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner
    https://www.nature.com/articles/s44222-022-00007-3
    LFT testing has enabled healthcare workers to return to work, schools and workplaces to reopen, and economic recovery, including mass gatherings, border testing and travel testing. […] 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. […] 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 COVID-19 pandemic has revealed enormous inequities in access to tests, vaccines and therapeutics.
  • #93 Lateral flow test engineering and lessons learned from COVID-19 | Nature Reviews BioengineeringClose bannerClose banner
    https://www.nature.com/articles/s44222-022-00007-3
    LFT testing has enabled healthcare workers to return to work, schools and workplaces to reopen, and economic recovery, including mass gatherings, border testing and travel testing. […] 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. […] 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 COVID-19 pandemic has revealed enormous inequities in access to tests, vaccines and therapeutics.
  • #94 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 Access to COVID-19 Tools (ACT)-Accelerator diagnostic pillar (ACT-A Dx), part of the ACT-A mechanism, was established to increase equitable access to COVID-19 testing globally. […] The simplicity of LFTs comes with technical limitations and usage trade-offs. […] Innovations in ultra-sensitive nanomaterials, clustered regularly interspaced short palindromic repeats (CRISPR)-based detection, mobile app connectivity and deep learning have greatly improved LFT technology.
  • #95 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 Access to COVID-19 Tools (ACT)-Accelerator diagnostic pillar (ACT-A Dx), part of the ACT-A mechanism, was established to increase equitable access to COVID-19 testing globally. […] The simplicity of LFTs comes with technical limitations and usage trade-offs. […] Innovations in ultra-sensitive nanomaterials, clustered regularly interspaced short palindromic repeats (CRISPR)-based detection, mobile app connectivity and deep learning have greatly improved LFT technology.
  • #96 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 Access to COVID-19 Tools (ACT)-Accelerator diagnostic pillar (ACT-A Dx), part of the ACT-A mechanism, was established to increase equitable access to COVID-19 testing globally. […] The simplicity of LFTs comes with technical limitations and usage trade-offs. […] Innovations in ultra-sensitive nanomaterials, clustered regularly interspaced short palindromic repeats (CRISPR)-based detection, mobile app connectivity and deep learning have greatly improved LFT technology.
  • #97 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
    Bioengineering efforts could improve specimen preparation, incorporating nucleic acid-based amplification and detection, enabling multiplexing, digital connection with mobile-Health (m-Health) databases and healthcare systems, and green manufacture of products to create simple next-generation LFTs with high accuracy, ease of use, cost-effectiveness, and rapid testing with improved digital connectivity, especially for identifying infections caused by antibiotic-resistant microbes. […] Next-generation LFTs would target antigens, antibodies, and molecules, with AMR (antimicrobial resistance) panels and quick response (QR) codes, for use not only for self-testing, clinical diagnosis, screening and surveillance testing but also for environmental monitoring, using ultra-sensitive materials such as enzymatic nanoparticles, and nanodiamonds, with digitalized result capturing. […] 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.
  • #98 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
    Bioengineering efforts could improve specimen preparation, incorporating nucleic acid-based amplification and detection, enabling multiplexing, digital connection with mobile-Health (m-Health) databases and healthcare systems, and green manufacture of products to create simple next-generation LFTs with high accuracy, ease of use, cost-effectiveness, and rapid testing with improved digital connectivity, especially for identifying infections caused by antibiotic-resistant microbes. […] Next-generation LFTs would target antigens, antibodies, and molecules, with AMR (antimicrobial resistance) panels and quick response (QR) codes, for use not only for self-testing, clinical diagnosis, screening and surveillance testing but also for environmental monitoring, using ultra-sensitive materials such as enzymatic nanoparticles, and nanodiamonds, with digitalized result capturing. […] 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.
  • #99 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. […] The LFA technique for the early diagnosis has great potential for preventing, monitoring, and controlling COVID-19, especially in the post-pandemic era. […] 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.
  • #100 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
    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 detection of SARS-CoV-2 usually includes quantitative detection of different types of virus-specific IgG and IgM or the total level of IgG/IgM. […] LFAs are a powerful means of antibody determination in the POCT setting. Recently, antibody detection based on LFAs for SARS-CoV-2 has been widely reported. […] The purpose of antigen detection is to directly determine the viral proteins of SARS-CoV-2, such as N or S proteins. […] 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. […] A series of experiments were performed to evaluate the sensitivity and specificity of the SARS-CoV-2 antigen diagnostic test. […] Generally, antibody-based LFAs are sensitive and accurate. […] For infection monitoring and epidemiology studies, it can be a crucial tool in the post-pandemic era.
  • #101 Rapid tests for COVID-19 now, other diseases later the goal for Kourentzi | UH Cullen College of Engineering
    https://www.egr.uh.edu/news/202009/rapid-tests-covid-19-now-other-diseases-later-goal-kourentzi
    Kourentzi noted that the test needs to be reliable not missing any positives as well as specific not misidentifying a negative as a positive. […] Kourentzi stressed that while the current focus is on detecting the coronavirus, the testing platform could be used for other things as well. […] We expect the technology to be broadly useful in other areas of molecular diagnostics and biomedical research, she said.
  • #102 Rapid tests for COVID-19 now, other diseases later the goal for Kourentzi | UH Cullen College of Engineering
    https://www.egr.uh.edu/news/202009/rapid-tests-covid-19-now-other-diseases-later-goal-kourentzi
    Kourentzi noted that the test needs to be reliable not missing any positives as well as specific not misidentifying a negative as a positive. […] Kourentzi stressed that while the current focus is on detecting the coronavirus, the testing platform could be used for other things as well. […] We expect the technology to be broadly useful in other areas of molecular diagnostics and biomedical research, she said.
  • #103 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
    LFT feasibility and acceptability for large-scale SARS-CoV-2 testing to improve population health have been observed during the coronavirus disease 2019 (COVID-19) pandemic. […] In the present review, researchers described the evolution of LFT testing, the advantages and disadvantages of LFTs, and identified roadblocks in developing next-generation LFTs based on the lessons learnt from the COVID-19 pandemic. […] The COVID-19 period accelerated LFT development, during which cases of unknown-cause pneumonia were reported in Wuhan, genetic sequencing information was shared, and the World Health Organization (WHO) released interim guidelines on rapid antigen test usage. […] During COVID-19, LFTs used SARS-CoV-2 antigens, and their use was expanded to surveillance efforts. […] LFT sensitivity is reportedly lesser than RT-PCR analysis, in the range of 34.0% to 88.0% in detecting SARS-CoV-2 and 99.6% specificity.
  • #104 Coronavirus » Lateral flow antigen tests for asymptomatic staff testing: frequently asked questions for – primary care (organisations and staff)
    https://www.england.nhs.uk/coronavirus/documents/lateral-flow-antigen-tests-for-asymptomatic-staff-testing-frequently-asked-questions-for-primary-care-organisations-and-staff/
    Yes, everyone who has been vaccinated should continue to test. Vaccinated people will have more protection from COVID-19, and there is some early evidence that it can prevent a persons ability to transmit the virus, but it does not yet give guarantee that you cannot transmit the virus to patients and staff. […] Regular asymptomatic testing is voluntary, but staff should be strongly encouraged to be involved in LFD testing to protect themselves, colleagues and patients. Asymptomatic staff testing is an important component of Infection Prevention and Control, which all organisations and staff have a duty to adhere to. […] All asymptomatic staff who are delivering NHS services in primary care across all four contractor groups (medical, dental, optometry, and community pharmacy) in England are encouraged to test.
  • #105 Coronavirus » Lateral flow antigen tests for asymptomatic staff testing: frequently asked questions for – primary care (organisations and staff)
    https://www.england.nhs.uk/coronavirus/documents/lateral-flow-antigen-tests-for-asymptomatic-staff-testing-frequently-asked-questions-for-primary-care-organisations-and-staff/
    Yes, everyone who has been vaccinated should continue to test. Vaccinated people will have more protection from COVID-19, and there is some early evidence that it can prevent a persons ability to transmit the virus, but it does not yet give guarantee that you cannot transmit the virus to patients and staff. […] Regular asymptomatic testing is voluntary, but staff should be strongly encouraged to be involved in LFD testing to protect themselves, colleagues and patients. Asymptomatic staff testing is an important component of Infection Prevention and Control, which all organisations and staff have a duty to adhere to. […] All asymptomatic staff who are delivering NHS services in primary care across all four contractor groups (medical, dental, optometry, and community pharmacy) in England are encouraged to test.

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