Choroba chagasa
Diagnostyka i diagnoza

Choroba Chagasa, wywołana przez Trypanosoma cruzi, wymaga różnorodnych metod diagnostycznych dostosowanych do fazy choroby. W ostrej fazie (2-4 tygodnie po zakażeniu) zaleca się bezpośrednie badanie świeżej krwi, rozmazy barwione metodą Giemsy oraz metody zagęszczania (mikrohematokryt, test Strouta) o czułości 80-90%. W fazie przewlekłej, charakteryzującej się niską parazytemią, diagnostyka opiera się na serologii, stosując co najmniej dwa testy o różnych zasadach metodologicznych, np. ELISA (czułość 94-100%, swoistość 96-100%), pośrednią hemaglutynację (czułość 88-99%, swoistość 96-100%) oraz immunofluorescencję (czułość i swoistość ok. 98%). PCR jest użyteczne w fazie ostrej i reaktywacji, jednak w przewlekłej fazie wykrywa pasożyty u 40-70% pacjentów. Szybkie testy diagnostyczne (RDTs) mają czułość 75,5-99% i swoistość 70,9-100%, zalecane są jedynie do badań przesiewowych. Diagnostyka powinna uwzględniać kontekst epidemiologiczny, zwłaszcza u osób z obszarów endemicznych oraz u pacjentów z grup ryzyka, takich jak kobiety w ciąży, osoby z immunosupresją czy biorcy przeszczepów.

Diagnoza choroby Chagasa

Choroba Chagasa (trypanosomoza amerykańska) to zakażenie wywołane przez pasożytniczego pierwotniaka Trypanosoma cruzi. Prawidłowa i wczesna diagnoza tej choroby ma kluczowe znaczenie zarówno dla indywidualnego pacjenta, jak i z przyczyn epidemiologicznych, ponieważ transmisja poprzez transfuzję krwi i przeszczep narządów może występować w krajach endemicznych i nieendemicznych1. Metody diagnostyczne różnią się w zależności od fazy choroby, dostępności zasobów laboratoryjnych i celu badania2.

Diagnostyka ostrej choroby Chagasa

W ostrej fazie choroby Chagasa, która trwa 2-4 tygodnie po początkowym zakażeniu, pasożyty krążą swobodnie w krwiobiegu1. W tym okresie diagnoza opiera się na bezpośrednim wykryciu pasożyta za pomocą metod parazytologicznych2:

  • Badanie świeżej krwi – bezpośrednie badanie świeżej próbki krwi jest bardziej czułe niż barwiony rozmaz i powinno być metodą z wyboru podczas ostrej fazy zakażenia1
  • Badanie mikroskopowe rozmazu krwi – wykonuje się cienkie i grube rozmazy krwi barwione metodą Giemsy w celu wizualizacji pasożytów23
  • Metody zagęszczania (mikrohematokryt lub test Strouta) – mają czułość 80-90% i są zalecane w przypadku pacjentów z podejrzeniem ostrej choroby Chagasa, u których wyniki bezpośredniego badania świeżej krwi są negatywne1

W przypadkach objawowych trwających dłużej niż 30 dni, gdy testy bezpośrednie są negatywne, metody zagęszczania powinny być pierwszym wyborem, ponieważ na tym etapie pasożytemia zaczyna się zmniejszać1. Pracownicy ochrony zdrowia diagnozują ostre zakażenia Chagasa poprzez identyfikację trypomastigotów we krwi przy użyciu mikroskopii2.

Diagnostyka przewlekłej choroby Chagasa

Faza przewlekła, która następuje po ustąpieniu ostrego zakażenia, charakteryzuje się poziomami krążących pasożytów znacznie poniżej progu wykrywalności mikroskopowej oraz pojawieniem się przeciwciał IgG skierowanych przeciwko antygenom Trypanosoma cruzi1. Diagnostyka w tej fazie opiera się głównie na metodach serologicznych2.

Światowa Organizacja Zdrowia (WHO) i Panamerykańska Organizacja Zdrowia (PAHO) zdecydowanie zalecają użycie co najmniej 2 testów serologicznych wykorzystujących różne zasady metodologiczne lub antygeny1:

Według Ministerstwa Zdrowia (2005), diagnoza podczas przewlekłej fazy choroby Chagasa powinna być przeprowadzana przy użyciu testu o wysokiej czułości (ELISA z całkowitym antygenem lub półoczyszczonymi frakcjami pasożyta, IIF lub IHA) w połączeniu z innym równoległym testem o wysokiej swoistości (ELISA, z użyciem specyficznych dla T. cruzi rekombinowanych antygenów). Jeśli wyniki nie są zgodne, diagnoza jest uznawana za niejednoznaczną. W takich przypadkach próbki muszą zostać ponownie przebadane przy użyciu tych samych metod1.

Najczęściej stosowane techniki serologiczne obejmują2:

  • Test immunoenzymatyczny ELISA (czułość = 94-100%, swoistość = 96-100%)1
  • Pośrednią hemaglutynację (HAI, czułość = 88-99%, swoistość = 96-100%)2
  • Pośrednią immunofluorescencję (IFI, czułość = 98%, swoistość = 98%)3

Diagnostyka przewlekłej choroby Chagasa jest wyzwaniem ze względu na różne szczepy T. cruzi, zróżnicowane odpowiedzi immunologiczne na zakażenie i zmienne poziomy przeciwciał podczas fazy przewlekłej1. Nie ma pojedynczego złotego standardu badania, dlatego Światowa Organizacja Zdrowia zaleca diagnozowanie choroby Chagasa za pomocą dwóch testów serologicznych różnych typów2.

Metody molekularne w diagnostyce choroby Chagasa

W ostatnich latach reakcja łańcuchowa polimerazy (PCR) była dominującą techniką molekularną stosowaną w diagnostyce choroby Chagasa1. PCR okazała się użyteczna podczas ostrej fazy lub reaktywacji fazy przewlekłej ze względu na większą czułość w porównaniu do metod mikroskopowych2.

Przydatność PCR w fazie przewlekłej jest dyskusyjna, ponieważ daje pozytywny wynik u 40-70% pacjentów, którzy wcześniej zostali zdiagnozowani konwencjonalnymi metodami serologicznymi, w zależności od stopnia parazytemii, objętości próbki, oczyszczania DNA, regionu docelowego, charakterystyki populacji badanej i dużej zmienności genetycznej między jednostkami typowania pasożytów (DTUs)3.

Molekularna diagnostyka choroby Chagasa jest wykonywana w przypadkach1:

  • Podejrzenia ostrego zakażenia (w tym przeniesienia przez transfuzję lub przeszczep)
  • Wrodzonej choroby Chagasa
  • Monitorowania podejrzewanych ekspozycji laboratoryjnych
  • Reaktywowanych przypadków związanych z immunosupresją2

W CDC (Centrum Kontroli i Zapobiegania Chorobom) molekularne wykrywanie DNA T. cruzi jest wykonywane przy użyciu kombinacji dwóch testów PCR w czasie rzeczywistym (TCZ i MNC). Akceptowalnymi rodzajami próbek są krew EDTA (minimum 2,2 ml), wycinek biopsyjny serca (w soli fizjologicznej lub zatopiony w parafinie) oraz, w przypadkach podejrzenia zajęcia ośrodkowego układu nerwowego, płyn mózgowo-rdzeniowy3.

Inną techniką jest amplifikacja izotermiczna wspomagana pętlą (LAMP), czuła, specyficzna metoda molekularna, która jest prostsza, szybsza i tańsza niż PCR i jej warianty i musi być wykorzystywana w diagnostyce CD1.

Szybkie testy diagnostyczne (RDTs)

W ciągu ostatnich 2 dekad, rozwój komercyjny zaowocował szybkimi testami diagnostycznymi (RDTs) zaprojektowanymi do wykrywania specyficznych dla T. cruzi immunoglobulin G (IgG). RDTs są łatwymi w użyciu diagnostycznymi narzędziami typu point-of-care, które zazwyczaj dostarczają wyniki w ciągu 30 minut1.

Jednak warto zauważyć, że obecnie RDTs są zalecane tylko do celów przesiewowych, a nie do diagnozy indywidualnej. Potwierdzenie serologiczne pacjenta jest obowiązkowe, co potencjalnie może powodować opóźnienie w rozpoczęciu leczenia, gdy jest to zalecane2.

Główne zalety RDTs to przenośność, minimalna objętość próbki krwi i odczynnika, przetwarzanie bez wirowania, tolerancja na wahania temperatury i szybkie wyniki, ułatwiające szybkie i skuteczne podejmowanie decyzji w określonych sytuacjach1.

Badanie 11 komercyjnie dostępnych RDTs przeprowadzone w Kolumbii wykazało, że czułość ocenianych RDTs wahała się od 75,5% do 99,0%, podczas gdy swoistość wahała się od 70,9% do 100%. Większość testów (7/11, 63,6%) miała czułość powyżej 90%, a prawie wszystkie (10/11, 90,9%) miały swoistość powyżej 90%. Pięć RDTs miało zarówno czułość, jak i swoistość powyżej 90%1.

Diagnostyka wrodzonej choroby Chagasa

Wczesne wykrycie pasożyta u kobiet i noworodków jest priorytetem zdrowia publicznego1. Problem polega na braku prostych, szybkich i wiarygodnych testów2.

W regionach endemicznych bardzo przydatny byłby prosty, szybki i czuły test do wykrywania pasożyta u noworodków, kiedy leczenie jest najbardziej skuteczne3. Test molekularny LAMP w połączeniu ze zmodyfikowaną drukarką 3D do ekstrakcji DNA (PrintrLab-LAMP) wykazał czułość wyższą niż mikroskopia i prawie równą PCR4.

Zaletą PrintrLab-LAMP jest to, że powinien być tańszy niż PCR i wymaga minimalnej infrastruktury1. Badania wykazały, że wszystkie zakażone noworodki, u których zastosowano wytyczne kraju dotyczące diagnostyki i leczenia wrodzonej choroby Chagasa, były leczone i wyleczone, co podkreśla znaczenie wczesnego wykrywania i leczenia2.

Czułość badania mikroskopowego krwi z antykoagulantem i PCR jest mniejsza niż 100%. Dlatego u niemowlęcia, które uzyskało wynik negatywny w tych badaniach bezpośrednio po urodzeniu, może w rzeczywistości występować zakażenie T. cruzi1.

Badania diagnostyczne w kontekscie przeszczepu i transfuzji

Selektywne badania przesiewowe są zalecane zarówno u biorców przeszczepów narządów, jak i żywych dawców, u których istnieje ryzyko choroby Chagasa, w celu identyfikacji możliwości przeniesienia lub reaktywacji i złagodzenia potencjalnych poważnych powikłań1.

Amerykańskie Towarzystwo Transplantologiczne (AST) zaleca serologiczne badanie metodą podwójną w celu wykrycia przewlekłego zakażenia Chagasa u każdego kandydata do przeszczepu, który może być narażony na tę chorobę2.

Badania przesiewowe krwi i przeszkodów narządów są powszechnie stosowane w krajach endemicznych Ameryki Łacińskiej1. Ryzyko nabycia zakażenia T. cruzi po transfuzji zakażonej jednostki szacuje się na 10–25%2.

Algorytmy diagnostyczne i wyzwania

Nie ma konsensusu co do algorytmów diagnostycznych dla wielu scenariuszy zakażenia Trypanosoma cruzi, co utrudnia ustanowienie wytycznych rządowych w krajach endemicznych i nieendemicznych1.

Złożoność choroby Chagasa i jej faz uniemożliwia posiadanie jednego testu dla obu faz i wielu różnych scenariuszy epidemiologicznych1. Obecnie serologia jest standardową techniką referencyjną; okazjonalnie wyniki są niejednoznaczne i potrzebna jest inna technika diagnostyczna2.

Badania przesiewowe w kierunku choroby Chagasa

Badania przesiewowe w kierunku choroby Chagasa są kluczowe dla wczesnego wykrycia i leczenia tej choroby pasożytniczej1. Według szacunków, choroba Chagasa dotyka około 326 000-347 000 osób w Stanach Zjednoczonych i jest poważnie niedodiagnozowana2. Brak świadomości i jasności w zakresie badań przesiewowych i diagnostyki stanowi kluczową barierę3.

Grupy ryzyka wymagające badań przesiewowych

Osoby, które urodziły się lub przebywały przez dłuższy czas w krajach endemicznych Meksyku oraz Ameryki Środkowej i Południowej, powinny być badane na obecność zakażenia Trypanosoma cruzi, a członkowie rodzin osób z wynikiem pozytywnym powinni zostać poddani badaniom przesiewowym1.

Szacuje się, że 99% pacjentów nie wie o zakażeniu, dlatego zaleca się rutynowe badania przesiewowe dorosłych, którzy mieszkali w endemicznych krajach Ameryki Łacińskiej1. Inne grupy, takie jak osoby spędzające znaczną ilość czasu na kempingu/polowaniu/pracy na świeżym powietrzu w endemicznych stanach południowych USA, również mogą odnieść korzyści z badań przesiewowych2.

Testy diagnostyczne powinny być wykonywane u wszystkich pacjentów z obszarów endemicznych choroby Chagasa i pacjentów z czynnikami ryzyka epidemiologicznego zakażenia (np. byłe miejsce zamieszkania w obszarze endemicznym, historia matczyna choroby Chagasa, niemonitorowana transfuzja krwi)1.

Strategie badań przesiewowych

W Stanach Zjednoczonych zaleca się badania przesiewowe wszystkich osób, które mieszkały w Meksyku lub Ameryce Środkowej lub Południowej przez ponad 6 miesięcy1. Jest to szczególnie ważne dla osób z HIV ze względu na ryzyko reaktywacji choroby2.

Każdy, kto mieszkał na obszarach endemicznych, powinien zostać przebadany w kierunku choroby Chagasa, szczególnie jeśli jest w ciąży, aby zidentyfikować zakażenie matki i możliwe ryzyko zakażenia u jej potomstwa1.

Należy oferować badania przesiewowe przed poczęciem kobietom migrantkom z Ameryki Łacińskiej w wieku rozrodczym. Badania przesiewowe przed poczęciem z leczeniem mogą również zmniejszyć ryzyko zakażenia wrodzonego1.

Należy oferować badania serologiczne kobietom w ciąży, które są migrantkami z Ameryki Łacińskiej. Chociaż leczenie choroby Chagasa podczas ciąży jest przeciwwskazane, identyfikacja jest ważna w celu wykrycia i leczenia zakażenia wrodzonego1.

Należy oferować badania przesiewowe osobom z obniżoną odpornością (szczególnie tym z zakażeniem HIV, poddawanym przeszczepom lub chemioterapii nowotworowej), ponieważ mogą być one narażone na ryzyko reaktywacji zakażenia i związanych z tym powikłań2.

Kompleksowe podejście do diagnostyki choroby Chagasa

Kompleksowe podejście do diagnostyki choroby Chagasa wymaga uwzględnienia kontekstu klinicznego, epidemiologicznego oraz odpowiednich badań laboratoryjnych1.

Badania kliniczne i laboratoryjne

Pracownik służby zdrowia przeprowadza badanie fizykalne, pytając o objawy i wszystko, co naraziło cię na ryzyko choroby Chagasa1. Jeśli masz objawy choroby Chagasa, dwa lub więcej badań krwi mogą potwierdzić diagnozę2.

Jeśli zdiagnozowano u ciebie chorobę Chagasa, prawdopodobnie będziesz miał więcej badań. Te badania mogą pokazać, czy choroba stała się przewlekła i spowodowała powikłania sercowe lub trawienne3.

Badania mogą obejmować1:

  • Echokardiogram
  • Elektrokardiogram (EKG)
  • Zdjęcie rentgenowskie lub tomografię komputerową
  • Biopsję serca
  • Endoskopię górnego odcinka przewodu pokarmowego
  • Kolonoskopię

Kluczowe czynniki diagnostyczne obejmują obecność czynników ryzyka, przedłużoną gorączkę, kołatanie serca, omdlenia lub stany przedomdleniowe, powiększenie wątroby i śledziony, powiększone węzły chłonne, tachykardię, niedociśnienie, powiększenie serca, dysfagię, regurgitację/aspirację, odynofagię, dyskomfort zamostkowy, przedłużone zaparcia, ostry ból brzucha, wzdęcie brzucha, obrzęk wokół miejsca inokulacji, żółtaczkę, tkliwość brzucha przy odbiciu, kliniczne objawy podrażnienia opon mózgowych i kliniczne objawy zmiany masowej w mózgu1.

Rozpoznanie różnicowe

Choroba Chagasa jest elementem diagnostyki różnicowej u psów z arytmiami, dysfunkcją mięśnia sercowego i zastoinową niewydolnością serca. Może prezentować objawy podobne do kardiomiopatii rozstrzeniowej (idiopatycznej, niedoboru składników odżywczych), arytmogennej kardiomiopatii prawej komory, innych form zakaźnego zapalenia mięśnia sercowego i wrodzonej dysplazji zastawki trójdzielnej1.

W przypadku podejrzenia choroby Chagasa u pacjentów leczonych z powodu HIV, koinfekcja z T. cruzi i choroba reaktywacyjna powinny być brane pod uwagę w diagnostyce różnicowej zmian masowych OUN, zapalenia opon mózgowych i mózgu, zaburzeń rytmu serca lub niewydolności serca1.

Faza choroby Metody diagnostyczne Czułość Zalecenia
Ostra Bezpośrednie badanie mikroskopowe świeżej krwi Wysoka w ostrej fazie Metoda z wyboru w ostrej fazie
Ostra Rozmaz krwi barwiony metodą Giemsy Niższa niż badanie świeżej krwi Alternatywa dla badania świeżej krwi
Ostra Metody zagęszczania (mikrohematokryt lub test Strouta) 80-90% Zalecane przy negatywnych wynikach bezpośrednich
Przewlekła ELISA 94-100% Zalecane w połączeniu z innym testem
Przewlekła Pośrednia hemaglutynacja (HAI) 88-99% Zalecane w połączeniu z innym testem
Przewlekła Pośrednia immunofluorescencja (IFI) 98% Zalecane w połączeniu z innym testem
Ostra i przewlekła PCR Zmienna (40-70% w fazie przewlekłej) Użyteczna w ostrej fazie i reaktywacji
Przesiewowe Szybkie testy diagnostyczne (RDTs) 75,5-99,0% Zalecane tylko do celów przesiewowych

Wyzwania w diagnostyce choroby Chagasa

Diagnoza choroby Chagasa ma ograniczenia, głównie ze względu na wielką złożoność czynników, które jej dotyczą, a także niską czułość technik parazytologicznych i niską swoistość testów immunologicznych1.

Brak powszechnie dostępnej standardowej referencyjnej próby serologicznej do diagnozy zakażenia T. cruzi skłonił do opracowania nowych testów, które wymagają dalszej oceny, więc rozwój metod diagnostycznych do wykrywania zakażeń T. cruzi, po ponad stu latach od jego odkrycia, pozostaje wyzwaniem, które zależy głównie od dostępności specyficznych antygenów o wysokim powinowactwie1.

Algorytm wykorzystujący szybkie testy diagnostyczne (RDTs) wykazał dużą zgodność ze standardowym algorytmem, z czułością 94,6% i swoistością 98,6%. Wyniki te mają kluczowe znaczenie dla inicjatyw zdrowia publicznego, ponieważ potwierdzają połączone stosowanie RDTs i konwencjonalnej serologii, algorytmu zaproponowanego przez paragwajskie władze zdrowotne dla środowisk o ograniczonych zasobach1.

Wyzwaniem pozostaje przejście od zaleceń do wdrożenia praktyki i w tym sensie kluczowe jest dostosowanie tych zaleceń do każdych szczególnych ram na poziomie krajowym1.

Nowe kierunki w diagnostyce choroby Chagasa

Rozwój nowych metod diagnostycznych dla choroby Chagasa jest obszarem intensywnych badań, mających na celu przezwyciężenie ograniczeń istniejących technik1.

Innowacyjne podejścia diagnostyczne

Naukowcy stworzyli lepszy sposób diagnozowania tej choroby zakaźnej, co mogłoby znacznie poprawić wyniki u pacjentów1. Diagnozowanie choroby Chagasa może być trudne, ponieważ pasożyty, które powodują chorobę, mają tendencję do różnienia się w zależności od miejsca ich występowania2.

„Choroba Chagasa to prawdziwa zagadka, jeśli chodzi o diagnozę. Pacjenci w ostrej fazie zazwyczaj nie mają objawów, gdy obciążenie pasożytami jest najwyższe w krwiobiegu. Ale gdy objawy pojawiają się w fazie przewlekłej, obciążenie pasożytami jest znacznie niższe i trudniejsze do wykrycia w próbkach krwi” – wyjaśnił pierwszy autor badania Priscila Silva Grijo Farani3.

Nowa metoda wykorzystuje kulki magnetyczne, które wiążą się z DNA. Po chemicznym otwarciu komórek we krwi, kulki magnetyczne mogą być zastosowane do próbki. Kulki wychwytują więcej DNA o wyższej jakości w porównaniu ze starą metodą. W ten sposób nowa metoda przedstawia lepszą, bardziej czułą metodę wykrywania1.

Farani wyjaśniła, że w porównaniu z kolumnami krzemionkowymi, kulki magnetyczne dawały większą ilość czystego DNA i znacznie zwiększały czułość wykrywania pasożytów we krwi, co czyni je bardziej wiarygodnym wskaźnikiem obecności pasożytów we krwi1.

Nowe testy molekularne i serologiczne

Eurofins Viracor, LLC, wiodący dostawca specjalistycznych badań diagnostycznych, z przyjemnością ogłasza wprowadzenie innowacyjnego ilościowego testu PCR do wykrywania Trypanosoma cruzi (T. cruzi), pasożytniczej przyczyny choroby Chagasa1.

Test Chagas (T. cruzi) qPCR jest kluczowym narzędziem do dokładnego wykrywania zakażenia Trypanosoma cruzi, choroby, która często pozostaje niezdiagnozowana ze względu na swój bezobjawowy charakter we wczesnych stadiach2.

Nowy test oferuje1:

  • Czuły, ilościowy test PCR z szybkim czasem realizacji, dostarczający wyniki w ciągu 48 godzin od otrzymania próbki

Laboratorium Biologii Molekularnej i Chorób Endemicznych IOC przygotowuje również protokół dla PCR w czasie rzeczywistym, jeszcze bardziej czułej odmiany metody, do diagnozowania różnych linii T. cruzi i umożliwienia monitorowania parazytemii u pacjentów poddawanych schematom terapeutycznym1.

Testy serologiczne o wysokiej wydajności do diagnostyki przewlekłej choroby Chagasa zostały wygenerowane poprzez włączenie dziesięciu specyficznych dla T. cruzi epitopów do pętli struktur β-baryłki białek fluorescencyjnych1.

Pierwszy projekt białka deca-epitopowego, DxCruziV1, okazał się łatwy do ekspresji w bakteriach. Co więcej, wykazał 100% czułości i 100% swoistości, co było trudnym do osiągnięcia wynikiem dla odczynników immunologicznych do diagnozowania choroby Chagasa2.

Podsumowanie i przyszłe kierunki

Dokładna i czuła diagnoza choroby Chagasa jest ważna dla skutecznego leczenia i przyjęcia środków kontroli przeciwko chorobie1. To badanie wykazało, że technika ELISA wykazała lepszą wydajność diagnostyczną w przewlekłej i ostrej fazie choroby Chagasa w porównaniu do innych technik serologicznych (HmT i IFAT) i molekularnych (PCR i qPCR), sugerując jej wykonalność do stosowania w czułej i specyficznej diagnostyce choroby Chagasa2.

Mimo to, sytuacja ujawnia pilną potrzebę opracowania nowych narzędzi diagnostycznych do diagnozowania choroby3. PATH zidentyfikowała cztery przypadki użycia diagnostyki choroby Chagasa: diagnostyka przypadków, wykrywanie przypadków wrodzonych, monitorowanie leczenia oraz badania przesiewowe dawców krwi i organów1.

Na podstawie tych ustaleń, oferują następujące zalecenia2:

  • Ustanowienie bardziej znormalizowanych polityk i praktyk dotyczących diagnozy i leczenia choroby Chagasa poprzez generowanie dowodów na temat skuteczności obecnych narzędzi w różnych warunkach i budowanie konsensusu wokół standardów wśród globalnych i regionalnych interesariuszy
  • Opracowanie diagnostycznego narzędzia point-of-care do wykrywania zakażeń wrodzonych, co umożliwiłoby wczesne rozpoczęcie leczenia i wyraźne powiązanie z opieką poporodową
  • Opracowanie narzędzia diagnostycznego do monitorowania skuteczności leczenia, które informowałoby o podejmowaniu decyzji klinicznych podczas leczenia i wspierałoby rozwój lepszych leków1

Wyzwaniem pozostaje przejście od zaleceń do wdrożenia praktyki, i w tym sensie kluczowe jest dostosowanie tych zaleceń do każdych szczególnych ram na poziomie krajowym1.

Kolejne rozdziały

Zapraszamy do dalszego czytania naszego leksykonu.

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

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

Materiały źródłowe

  • #1 SciELO Brazil – Diagnosis of Chagas disease: what has been achieved? What remains to be done with regard to diagnosis and follow up studies? Diagnosis of Chagas disease: what has been achieved? What remains to be done with regard to diagnosis and follow
    https://www.scielo.br/j/mioc/a/7YskN7vmgRkfTfsPfFkqQKb/
    The chronic phase of the disease, which follows the resolution of the acute infection, is characterised by levels of circulating parasites far below the threshold for microscopic detection and also by the appearance of IgG antibodies directed against the antigens of Trypanosoma cruzi. Diagnosis in this phase is based primarily on conventional serology (CS), IIF, IHA, enzyme-linked immunosorbent assay-ELISA) or indirect parasitological methods (XD and haemoculture). Although specific, these indirect parasitological methods have low sensitivity (20-50%). In view of the low sensitivity of parasitological tests, diagnosis during the chronic phase is at present essentially serological. Accurate diagnosis at this stage is important for the individual and also for epidemiological reasons, because transmission by way of blood transfusion and organ transplantation occurs in endemic and non-endemic countries.
  • #1 Center of Excellence for Chagas Disease | Slymar, CA | Chagas Diagnosis
    https://chagasus.org/diagnosis/
    Diagnosis of Chagas disease differs depending on the phase of the disease. It is very rare to encounter acute cases, since acute symptoms are easily confused with flu-like illnesses and seldom associated with triatomines. Diagnosis typically occurs during the chronic phase. […] It is estimated that 99% of patients are unaware they have the infection, which is why we recommend routine screening for adults who have lived in endemic Latin American countries. Other groups, such as people who spend significant time camping/hunting/working outdoors in endemic states of the southern U.S. might also benefit from screening. […] In the acute phase, which lasts 2-4 weeks after the initial infection, Trypanosoma cruzi can be observed swimming freely in the bloodstream. Diagnosis can be made by observing the parasite under a microscope in a blood smear.
  • #1 SciELO Brazil – Diagnosis of Chagas disease: what has been achieved? What remains to be done with regard to diagnosis and follow up studies? Diagnosis of Chagas disease: what has been achieved? What remains to be done with regard to diagnosis and follow
    https://www.scielo.br/j/mioc/a/7YskN7vmgRkfTfsPfFkqQKb/
    In the acute phase of Chagas disease, parasites circulate in the bloodstream. During this phase, laboratory diagnosis is based on observation of the parasite in the infected blood of individuals using a parasitological fresh-blood test, as well as smear and thick drop blood tests. The direct test using fresh blood is more sensitive than the stained smear test and should be the method of choice during the acute phase of infection. If these tests are negative, concentration tests must be carried out. Concentration tests (microhematocrit or Strout test) have a sensitivity of 80-90% and are recommended in the case of patients strongly suspected of having acute Chagas disease and returning negative results for the direct fresh-blood exam. In symptomatic cases lasting more than 30 days, for direct negative tests, concentration tests should be the first choice, as parasitaemia begins to decline at this stage.
  • #1 The use of rapid diagnostic tests for chronic Chagas disease: An expert meeting report | PLOS Neglected Tropical Diseases
    https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0012340
    Chagas disease, caused by Trypanosoma cruzi, affects millions of people globally and is associated with significant underdiagnosis and undertreatment. Current diagnostic algorithms face challenges in remote regions. We aimed to review the potential of rapid diagnostic tests (RDTs) for screening or diagnosing chronic Chagas disease in endemic areas. […] The results indicate that RDTs play a crucial role in surveillance and screening, although limitations in sensitivity and specificity exist. […] Despite these challenges, RDTs present a promising avenue for improving Chagas disease diagnosis in resource-limited settings. Future research and a collaborative approach are deemed essential for effective implementation. […] In line with international recommendations from the Pan American Health Organization (PAHO), the diagnosis of T. cruzi infection in the chronic phase of Chagas disease is made using serological tests. WHO and PAHO strongly recommend the use of at least 2 serological tests representing different methodological principles or antigens: one with high sensitivity (for instance, immunoenzymatic test referred to as the enzyme-linked immunosorbent assay) and one with high specificity (for instance, indirect hemagglutination). […] Despite its effectiveness, this algorithm requires time, laboratory infrastructure, and expertise often unavailable in many rural and hard-to-reach regions, resulting in the underdiagnosis and underreporting of infected individuals.
  • #1 SciELO Brazil – Diagnosis of Chagas disease: what has been achieved? What remains to be done with regard to diagnosis and follow up studies? Diagnosis of Chagas disease: what has been achieved? What remains to be done with regard to diagnosis and follow
    https://www.scielo.br/j/mioc/a/7YskN7vmgRkfTfsPfFkqQKb/
    According to the MS (2005), diagnosis during the chronic phase of Chagas disease should be carried out using a test with high sensitivity (ELISA with total antigen or semi-purified fractions of the parasite, IIF or IHA) in combination with another parallel test with high specificity (ELISA, using T. cruzi-specific, recombinant antigens). If the results do not concur, the diagnosis is deemed inconclusive. In such cases, the samples must be retested using the same methods. […] The World Health Organization (WHO) has long emphasised the need to employ defined antigens as a way of improving the serodiagnosis of Chagas disease. Several research groups have therefore used recombinant/synthetic and biochemically purified antigens. In order to be useful, these antigens must meet several criteria: (i) they should be present in T. cruzi isolates from different endemic areas, and absent from other infectious disease agents; (ii) they should be highly immunogenic in populations with different genetic backgrounds, irrespective of the clinical phase of Chagas disease and (iii) they should be stable and easily amenable to quality-control tests, to guarantee reproducibility.
  • #1 More than a Hundred Years in the Search for an Accurate Diagnosis for Chagas Disease: Current Panorama and Expectations | IntechOpen
    https://www.intechopen.com/chapters/67456
    Diagnostic methods for T. cruzi can be included in three main groups: parasitological, serological, and molecular. Parasitological methods aim to visualize the presence of parasites, and their sensitivity varies depending on the stage of infection. For diagnosis of the disease in the phase where the parasitemia is very low, immunological methods (serological) are based primarily on the search for G antibodies (IgG) anti-T. cruzi in the blood of patients and their colorimetric reaction visible in the case that the blood of the patients contains the antibodies. The most commonly used methods are ELISA test (sensitivity = 94-100%, specificity = 96-100%), indirect hemagglutination (HAI, sensitivity = 88-99%, specificity = 96-100%), and indirect immunofluorescence (IFI, sensitivity = 98%, specificity = 98%). Despite being highly sensitive and specific, serological tests can have some cross-reactivity.
  • #1 Center of Excellence for Chagas Disease | Slymar, CA | Chagas Diagnosis
    https://chagasus.org/diagnosis/
    Different strains of T. cruzi, differential immune responses to infection, and variable levels of antibodies during the chronic phase can make Chagas disease challenging to detect. There is no single gold standard assay. Rather, the World Health Organization recommends diagnosis of Chagas disease with two serologic assays of different types.
  • #1 Molecular diagnosis of Chagas disease: a systematic review and meta-analysis | Infectious Diseases of Poverty | Full Text
    https://idpjournal.biomedcentral.com/articles/10.1186/s40249-023-01143-7
    CD diagnosis depends on the phase (acute or chronic) in which a patient is found to be infected. […] For decades, serology has been a useful tool in the diagnosis of the chronic phase in CD, detecting anti-T. cruzi IgG antibodies. […] In recent years, PCR (polymerase chain reaction) has been the predominant molecular technique used. PCR has proven useful during acute-phase or chronic-phase reactivations due to its greater sensitivity compared to microscopy methods. […] The viability of PCR use during the chronic phase is debatable because it yields a positive result in 40-70% of patients who have previously been diagnosed by conventional serological methods, depending on the degree of parasitemia, sample volume, DNA purification, target region, study population characteristics, and great genetic variability between the parasites discrete typing units (DTUs).
  • #1 CDC – DPDx – American Trypanosomiasis
    https://www.cdc.gov/dpdx/trypanosomiasisamerican/index.html
    Molecular diagnosis of Chagas disease is performed for cases of suspected acute infection (including transfusion or transplant transmission), congenital Chagas disease, and for monitoring of suspected laboratory exposures. For chronic Chagas disease, serology is generally most appropriate, although molecular detection may be performed for re-activated cases associated with immunosuppression. […] At CDC molecular detection of T. cruzi DNA is performed using a combination of two real-time PCR assays (TCZ and MNC). Acceptable specimen types are EDTA blood (minimum of 2.2 ml), heart biopsy tissue (in saline or paraffin-embedded) and, in cases of suspected central nervous system involvement, CSF.
  • #1 Molecular diagnosis of Chagas disease: a systematic review and meta-analysis | Infectious Diseases of Poverty | Full Text
    https://idpjournal.biomedcentral.com/articles/10.1186/s40249-023-01143-7
    Another technique is loop-mediated isothermal amplification (LAMP), a sensitive, specific molecular method which is simpler, faster, and cheaper than PCR and its variants and must thus be used in CD diagnosis. […] There is no consensus regarding the most effective molecular protocol for the diagnosis of CD. […] Despite the availability of so many tests, there is no consensus on establishing reference techniques, and no single test is considered the gold standard for confirming the diagnosis of infection by this parasite due to complexity of Chagas disease. […] The diagnostic effectiveness of molecular techniques in the chronic phase presents a low sensitivity (cumulative sensitivity of 67%, 95% CI 65.4-68.5) for use as a routine diagnostic tool. This depends on the number of circulating parasites. Furthermore, in the chronic phase, parasitemia is low and intermittent. Therefore, in the processing of the sample from collection to the development of the test, there may be insufficiently high concentrations of parasitic DNA to be amplified. A possible solution to this limitation is the collection of several serial samples from the same patient at different times or an increase in the volume of blood drawn. […] The entire international community agrees that the most recommendable approach is the combination of both types of diagnosis.
  • #1 The use of rapid diagnostic tests for chronic Chagas disease: An expert meeting report | PLOS Neglected Tropical Diseases
    https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0012340
    Over the past 2 decades, commercial development has yielded rapid diagnostic tests (RDTs) designed for detecting T. cruzi-specific immunoglobulin G (IgG). RDTs are easy-to-use point-of-care diagnostic tools that typically provide results within 30 minutes. […] However, it is important to note that, at present, RDTs are recommended only for screening purposes and not for individual diagnosis. Serological confirmation of a patient is mandatory, potentially causing a delay in initiating treatment when recommended. […] The objective of the present discussion was to review the existing evidence supporting the use of RDTs for screening or diagnosing chronic Chagas disease. Additionally, the aim was to discuss the implications of eventually adopting and implementing these tests as a strategy for diagnosing Chagas disease, considering their current reported accuracy and sustainability as a public health response in Latin America.
  • #1 The use of rapid diagnostic tests for chronic Chagas disease: An expert meeting report | PLOS Neglected Tropical Diseases
    https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0012340
    While RDTs are not utilized for treatment decisions, evidence suggests that they facilitate and potentially enhance access to diagnosis. […] The group emphasized key advantages of RDTs, including portability, minimal blood sample and reagent volume, centrifugation-free processing, tolerance to temperature fluctuations, and rapid results, facilitating swift and effective decision-making in specific situations. […] In conclusion, experts unanimously advocate that discussions on the future development of RDTs should be guided by the actual diagnostic needs of national health systems, patients, and users in general. The most effective RDTs will be those that align with real diagnostic needs or objectives set by providers of public health services.
  • #1 Laboratory evaluation of eleven rapid diagnostic tests for serological diagnosis of Chagas disease in Colombia | PLOS Neglected Tropical Diseases
    https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0011547
    Chagas disease is a public health challenge in Colombia, where only an estimated 1.2% of people at risk have accessed diagnosis, while less than 0.5% of affected people have obtained treatment. […] Rapid diagnostic tests (RDTs) for Chagas disease could simplify diagnosis, but their performance in the epidemiological context of Colombia is not well known. […] Eleven RDTs were assessed, ten using 585 serum samples and one using 551 serum samples. Employing the current national diagnostic algorithm as a reference standard for serological diagnosis of chronic infection, the sensitivity of the assessed RDTs ranged from 75.5% to 99.0% (95% CI 70.5100), while specificity ranged from 70.9% to 100% (95% CI 65.3100). Most tests (7/11, 63.6%) had sensitivity above 90%, and almost all (10/11, 90.9%) had specificity above 90%. Five RDTs had both sensitivity and specificity above 90%.
  • #1 Chagas Disease Diagnosis in Newborns – ISGLOBAL
    https://www.isglobal.org/en/-/diagnostico-de-chagas-en-recien-nacidos
    The LAMP molecular diagnostic test, coupled with a modified 3D printer to extract DNA, has a sensitivity comparable to PCR, and can be used in laboratories with limited resources. […] An innovative test that combines a DNA extraction system inspired by a modified 3D printer (PrintrLab) with loop-mediated isothermal molecular amplification (LAMP) could be used to detect T. cruzi infection -responsible for Chagas disease- in newborns. […] Early detection of the parasite in women and newborns is therefore a public health priority. […] The problem is the lack of simple, rapid and reliable tests. […] In endemic regions, it would be very useful to have a simple, rapid and sensitive test to detect the parasite in newborns, when treatment is most effective. […] This shows that the sensitivity of PrintrLab-LAMP is higher than that of microscopy and almost equal to that of PCR.
  • #1 Chagas Disease Diagnosis in Newborns – ISGLOBAL
    https://www.isglobal.org/en/-/diagnostico-de-chagas-en-recien-nacidos
    The advantage is that PrintrLab should be cheaper than PCR and requires minimal infrastructure. […] Following the country’s guidelines for diagnosis and treatment of congenital Chagas disease, all infected newborns were treated and cured, highlighting the importance of early detection and treatment. […] The research team points out that this was a proof of concept to demonstrate the feasibility of the PrintrLab-LAMP test, and that it now needs to be tested on a larger scale and in a larger number of centres.
  • #1 Chagas Disease (American Trypanosomiasis) Workup: Approach Considerations, Laboratory Studies, Imaging Studies
    https://emedicine.medscape.com/article/214581-workup
    The usefulness of specific drug treatment in adults with chronic Trypanosoma cruzi infections has not been clearly demonstrated and is a matter of ongoing debate. […] The parasitologic cure rate in babies with congenital Chagas disease approaches 100% when a full course of treatment is given during the first year of life. […] The sensitivities of microscopic examination of anticoagulated blood and PCR are less than 100%. Thus, the occasional baby who tests negative in these approaches immediately after birth may actually be infected with T cruzi.
  • #1 Trypanosoma cruzi – Chagas Disease | Choose the Right Test
    https://arupconsult.com/content/trypanosoma-cruzi
    Therefore, during the chronic phase, serology is necessary to diagnose Chagas disease. […] Laboratory testing for Chagas disease is indicated in individuals who are at risk when clinical findings point to acute- or chronic-phase infection. […] Accurate diagnosis of Chagas disease requires the use of appropriate testing for the suspected stage of infection (either acute or chronic), which corresponds to detectable parasitemia. […] Blood smear and PCR testing may be used when acute-phase Chagas disease is suspected, whereas serology is preferred to detect chronic-phase infection. […] Because no single serologic test is adequately sensitive or specific to diagnose Chagas disease, two or more serologic methods are needed to confirm infection. […] Selective screening is recommended for both organ transplant recipients and living donors who are at risk for Chagas disease to identify the possibility of transmission or reactivation and mitigate potential serious complications. […] The American Society of Transplantation (AST) recommends dual-method serologic testing to screen for chronic Chagas infection in any transplant candidate who may be at risk for the disease.
  • #1 Diagnosis and clinical management of Chagas disease | RRTM
    https://www.dovepress.com/diagnosis-and-clinical-management-of-chagas-disease-an-increasing-chal-peer-reviewed-fulltext-article-RRTM
    Serology is used for primary diagnosis in the indeterminate or chronic stage. […] In untreated seropositive individuals, PCR should also be requested to detect and establish the level of parasitemia, particularly relevant in pregnant women, for whom detectable DNA carries an increased risk of mother-to-child transmission. […] The most commonly used approach is the screening with serology of at-risk pregnant women, aiming to diagnose infection in the newborn and, if present, offer treatment, which is highly successful in young children. […] Antenatal screening is a clear recommendation from the PAHO and the WHO, also in non-endemic countries. […] The implementation of antenatal screening programs requires the engagement from professionals and mothers. […] Detecting cases of infection by T. cruzi in this setting requires a high level of clinical suspicion, awareness of the variety of clinical presentations and prospective laboratory monitoring, as there is little guidance out of endemic countries. […] The risk of acquiring T. cruzi infection after transfusion of an infected unit is estimated to be 10 to 25%. […] Serological screening of blood donations is practised extensively in endemic Latin American countries.
  • #1 SciELO Brazil – Parasitological, serological and molecular diagnosis of acute and chronic Chagas disease: from field to laboratory Parasitological, serological and molecular diagnosis of acute and chronic Chagas disease: from field to laboratory
    https://www.scielo.br/j/mioc/a/WmNV3ywZFmXZfvPHmX4JzCx/
    There is no consensus on the diagnostic algorithms for many scenarios of Trypanosoma cruzi infection, which hinders the establishment of governmental guidelines in endemic and non-endemic countries. […] In the acute phase, parasitological methods are currently employed, and standardised surrogate molecular tests are being introduced to provide higher sensitivity and less operator-dependence. […] In the chronic phase, IgG-based serological assays are currently used, but if a single assay does not reach the required accuracy, PAHO/WHO recommends at least two immunological tests with different technical principles. […] Specific algorithms are applied to diagnose congenital infection, screen blood and organ donors or conduct epidemiological surveys. […] Detecting Chagas disease reactivation in immunosuppressed individuals is an area of increasing interest.
  • #1 Molecular diagnosis of Chagas disease: a systematic review and meta-analysis | Infectious Diseases of Poverty | Full Text
    https://idpjournal.biomedcentral.com/articles/10.1186/s40249-023-01143-7
    The complexity of the Chagas disease and its phases is impossible to have a unique test for both phases and a lot of different epidemiological scenarios. Currently, serology is the reference standard technique; occasionally, results are inconclusive, and a different diagnostic technique is needed. Some guidelines recommend molecular testing. A systematic review and meta-analysis of available molecular tools/techniques for the diagnosis of Chagas disease was performed to measure their heterogeneity and efficacy in detecting Trypanosoma cruzi infection in blood samples. […] The results described in this meta-analysis (qualitative and quantitative analyses) do not allow the selection of the optimal protocol of molecular method for the study of Trypanosoma cruzi infection in any of its phases, among other reasons due to the complexity of this infection. Continuous analysis and optimization of the different molecular techniques is crucial to implement this efficient diagnosis in endemic areas.
  • #1 Recommendations for Screening and Diagnosis of Chagas Disease in the United States
    https://pmc.ncbi.nlm.nih.gov/articles/PMC9071346/
    Chagas disease affects an estimated 326,000-347,000 people in the United States and is severely underdiagnosed. Lack of awareness and clarity regarding screening and diagnosis is a key barrier. This article provides straightforward recommendations, with the goal of simplifying identification and testing of people at risk for US healthcare providers. […] Individuals who were born or resided for prolonged time periods in endemic countries of Mexico and Central and South America should be tested for Trypanosoma cruzi infection, and family members of people who test positive should be screened. […] Diagnostic testing for chronic T. cruzi infection should be conducted using 2 distinct assays. […] Increasing provider-directed screening for T. cruzi infection is key to addressing this neglected public health challenge in the United States.
  • #1 Diagnosis – InfoChagas
    https://infochagas.org/en/diagnosis/
    Diagnostic tests should be performed in all patients from Chagas disease endemic areas and patients with epidemiologic risk factors for infection (e.g. former residence in an endemic area, maternal history of Chagas disease, unmonitored blood transfusion). […] Depending on the stage of disease, Chagas disease can be diagnosed using direct or indirect parasitological methods. […] A person is considered to have T. cruzi infection when there is laboratory confirmation of infection and a compatible epidemiological history.
  • #1 Chagas Disease: Adult and Adolescent OIs | NIH
    https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/chagas-disease
    Chagas disease (American trypanosomiasis) is caused by the protozoan parasite Trypanosoma cruzi. It is transmitted to humans by infected triatomine bugs (kissing bugs), and less commonly by transfusion, organ transplant, from mother to infant, and, in rare instances, by ingestion of contaminated food or drink. […] Screening with serological testing is recommended for all individuals who have lived in Mexico or Central or South America for greater than 6 months. […] Most persons infected with T. cruzi are in the chronic phase and are typically unaware of their infection. Screening for infection to identify persons with the indeterminate or early clinical forms of chronic Chagas disease is important to identify those who might benefit from antiparasitic treatment and counseling regarding potential transmission of T. cruzi to others (e.g., blood donation, organ donation). This is particularly important for people with HIV because of the risk of reactivation disease.
  • #1 Chagas Disease: Adult and Adolescent OIs | NIH
    https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/chagas-disease
    Anyone who has lived in endemic areas should be screened for Chagas disease, particularly if pregnant, to identify maternal infection and possible risk of infection in their offspring. […] All infants born to women with T. cruzi should undergo appropriate testing for congenitally acquired T. cruzi infection and be treated promptly if infection is confirmed.
  • #1
    https://www.gov.uk/guidance/chagas-disease-migrant-health-guide
    Chagas disease is increasingly reported in Latin American migrants who have settled in Europe. It has rarely been reported in the UK due to lack of testing and awareness. […] Offer serological testing for Chagas disease to Latin American migrants: […] If the disease is suspected, request serology for Chagas disease (clotted blood sample). […] If positive, and dependent upon the individual clinical presentation, refer the patient for: […] definitive serological confirmation of the diagnosis and consideration of anti-parasitic treatment by an expert parasitology centre in the UK: […] Treatment is generally considered to be more effective: […] Offer pre-conception screening to Latin American migrant women of child-bearing age. Pre-conception screening with treatment can also reduce the risk of congenital infection.
  • #1
    https://www.gov.uk/guidance/chagas-disease-migrant-health-guide
    Offer serological testing to pregnant women who are migrants from Latin America. While treatment of Chagas during pregnancy is contraindicated, identification is important to detect and treat congenital infection. Treatment of infants is highlight effective and well tolerated. Failure to identify and treat infected infants poses risk of morbidity and premature mortality from chronic Chagas later in life. […] Offer screening to immunosuppressed individuals (particularly those with HIV infection, undergoing transplantation or cancer chemotherapy) as they may be at risk of reactivation of infection and associated complications.
  • #1 Chagas disease – PAHO/WHO | Pan American Health Organization
    https://www.paho.org/en/topics/chagas-disease
    Chagas diagnosis is always clinical, epidemiological and based on laboratory testing (parasitology and serology). […] During the acute phase, Chagas disease can be diagnosed through parasitological methods, given the large number of parasites circulating in the blood. In the acute stage, the studies focus on the search and recognition of Trypanosoma cruzi in direct examination and staining of blood smears (methodology: direct parasitological), and in determining the seropostivity of serology tests. […] For chronic stage of the disease, Diagnosis is based on clinical assessment, serology and epidemiological history. The definitive diagnosis of T. cruzi infection depends on the positive result of at least two different serologic tests (ELISA, indirect immunofluorescence and indirect hemagglutination) that detect specific antibodies in patient sera.
  • #1 Chagas disease – Diagnosis & treatment – Mayo Clinic
    https://www.mayoclinic.org/diseases-conditions/chagas-disease/diagnosis-treatment/drc-20356218
    Your healthcare professional does a physical exam, asking about your symptoms and anything that put you at risk of Chagas disease. If you have symptoms of Chagas disease, two or more blood tests can confirm the diagnosis. […] If you’re diagnosed with Chagas disease, you’re likely to have more tests. These tests can show whether the disease has become chronic and caused heart or digestive complications. Tests may include: […] Treatment for Chagas disease is to kill the parasite and ease symptoms. […] For Chagas disease, some basic questions to ask include: […] What tests do I need? […] Your healthcare professional is likely to ask questions, including: […] What, if anything, makes your symptoms worse? Have you lived or traveled anywhere, such as Mexico, where the triatomine bug or Chagas disease is common?
  • #1 Chagas Disease: Causes, Symptoms & Treatment
    https://my.clevelandclinic.org/health/diseases/21876-chagas-disease
    Chagas disease (American trypanosomiasis) is a parasitic infection spread by triatomine bugs, or kissing bugs. Antiparasitics can treat it, but theyre more effective in early stages. […] Healthcare providers diagnose a Chagas infection with a blood test to look for antibodies to the parasite. If you have symptoms of heart or digestive issues, you may also need additional tests, including: Echocardiogram, Electrocardiogram (EKG/ECG), X-ray or CT scan, Cardiac biopsy, Upper endoscopy, Colonoscopy. […] Providers use antiparasitic medications to treat Chagas, including benznidazole and nifurtimox. These are most effective when used in the acute phase or early in the chronic phase. […] If you treat Chagas early, you have a better chance of getting rid of the parasites before they can cause serious complications. Youll need to take medications for a month or more. Antiparasitics may be less effective at curing chronic infections, but they might reduce your risk of severe complications.
  • #1 Chagas disease – Symptoms, diagnosis and treatment | BMJ Best Practice
    https://bestpractice.bmj.com/topics/en-gb/1160
    The term Chagas disease is used for the general disease, whereas the term Chagas cardiomyopathy encompasses all cases of Chagas disease with cardiac involvement. […] Key diagnostic factors include presence of risk factors, prolonged fever, palpitations, syncope or presyncope, hepatosplenomegaly, enlarged lymph nodes, tachycardia, hypotension, cardiomegaly, dysphagia, regurgitation/aspiration, odynophagia, substernal discomfort, prolonged constipation, acute abdominal pain, abdominal distension, swelling around the site of inoculation, jaundice, abdominal rebound tenderness, clinical evidence of meningeal irritation, and clinical signs of a cerebral mass lesion. […] Diagnostic investigations include FBC, LFTs, serum electrolytes, urea nitrogen, and creatinine, microscopy (fresh blood, concentration methods, thick blood smear), enzyme-linked immunosorbent assay based on parasite lysate, immunofluorescent antibody test, indirect haemagglutination antibody test, chemiluminescence, radio-immunoprecipitation assay, western blot, polymerase chain reaction (PCR), urinalysis, serum or urine beta-hCG, ECG with a 30-second lead II rhythm strip, chest x-ray, barium swallow, and barium enema. […] Emerging tests include immunochromatography and commercial polymerase chain reaction (PCR) kits.
  • #1 Chagas Disease in Dogs: Transmission, Diagnosis, Treatment, and Prevention
    https://todaysveterinarypractice.com/parasitology/chagas-disease-dogs/
    Chagas disease is a diagnostic differential for dogs with arrhythmias, myocardial dysfunction, and congestive heart failure. It can present with findings similar to those of dilated cardiomyopathy (idiopathic, nutritional deficiency), arrhythmogenic right ventricular cardiomyopathy, other forms of infectious myocarditis, and congenital tricuspid valve dysplasia. The index of suspicion for Chagas disease increases in dogs from an endemic location or that have originated from, traveled to, or are currently living in an area where Chagas disease has been reported. Testing should be considered for dogs with a mother, littermate, or housemate (dog or cat) that has tested positive for T. cruzi infection. As there is no gold standard test, the sensitivity and specificity of the available tests are unknown.
  • #1 Chagas Disease: Adult and Adolescent OIs | NIH
    https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/chagas-disease
    Diagnosis of chronic infection relies on serological methods to detect immunoglobulin G antibodies to T. cruzi, most commonly enzyme-linked immunosorbent assay (ELISA) and immunofluorescent antibody assay (IFA). No available assay has sufficient sensitivity and specificity to be used alone; a single positive result does not constitute a confirmed diagnosis. […] In people with HIV and epidemiologic risk factors for Chagas disease, coinfection with T. cruzi and reactivation disease should be considered in the differential diagnosis of CNS mass lesions, meningoencephalitis, arrhythmias or heart failure. […] Testing to identify T. cruzi should be considered in all at-risk individuals with suspected reactivation of chronic Chagas disease. Initial assessment can be done by evaluation of a peripheral blood smear.
  • #1 Chagas disease: an overview of diagnosis – MedCrave online
    https://medcraveonline.com/JMEN/chagas-disease-an-overview-of-diagnosis.html
    The use of a quantitative method such as immunoblotting (Western blot) can be very useful on inconclusive results, mainly in countries with endemic presence of other trypanosomatids such as Leishmania spp. […] The utilization of this technique to diagnostic purposes remains limited since it implies a higher cost than the conventional serological tools and requires trained and specialized staff. […] The diagnosis of Chagas disease has limitations, mainly due to the great complexity of the factors that involve it, as well as to the low sensitivity of the parasitological techniques and the low specificity of the immunological tests. […] Molecular techniques, such as the polymerase chain reaction (PCR), which detect specific and repeated DNA sequences of the parasite, represent a suitable alternative for diagnosis in some situations, particularly in acute cases, in congenital transmission and in the evaluation and control of treatment.
  • #1 More than a Hundred Years in the Search for an Accurate Diagnosis for Chagas Disease: Current Panorama and Expectations | IntechOpen
    https://www.intechopen.com/chapters/67456
    The lack of a reference standard serological assay for the diagnosis of T. cruzi infection has prompted the development of new tests, which require further evaluation, so that the development of diagnostic methods for detecting T. cruzi infections, after more than a hundred years of its discovery, remains a challenge which depends mainly on the availability of specific high-affinity antigens. The diagnosis of Chagas disease has limitations, mainly due to the great complexity of the factors that involve it, as well as to the low sensitivity of the parasitological techniques and the low specificity of the immunological tests.
  • #1 Chagas disease study in Paraguay supports use of rapid tests to improve access to diagnosis
    https://medicalxpress.com/news/2025-02-chagas-disease-paraguay-rapid-access.html
    Rapid tests could be used to diagnose Chagas disease in resource-limited areas, according to a study led by the Barcelona Institute for Global Health (ISGlobal). The results of this research, published in PLOS Neglected Tropical Diseases, show that the prevalence of Chagas in an indigenous community in Paraguay is six times higher than in the country’s capital. […] Chagas is primarily diagnosed by serological techniques—the detection of antibodies to T. cruzi in the blood—during the chronic phase of the disease. To improve diagnostic access, Paraguayan health authorities proposed a new algorithm for resource-limited settings: a combination of rapid diagnostic tests (RDTs) followed by conventional serological tests, such as enzyme-linked immunosorbent assay (ELISA). […] The algorithm using rapid diagnostic tests (RDTs) showed high agreement with the standard algorithm, with a sensitivity of 94.6% and a specificity of 98.6%. These results are crucial for public health initiatives, as they validate the combined use of RDTs and conventional serology, an algorithm proposed by Paraguayan health authorities for resource-limited settings.
  • #1 WHF IASC Roadmap on Chagas Disease | Global Heart
    https://globalheartjournal.com/articles/10.5334/gh.484
    The diagnostic process is cumbersome, with suboptimal test performance that requires confirmatory testing. […] The efficacy of treatment in the acute phase is almost immediately demonstrable by negative parasitemia with direct or indirect parasitological testing. […] Anti-parasitic treatment should be provided as soon as possible following detection of acute T. cruzi infection. […] The absence of parasitemia, demonstrated by direct methods such as Strout or micro method, and negative PCR results always precede the reduction of antibodies. […] In the absence of a gold standard, serological tests to confirm cure and molecular tests to demonstrate failure are the best available tools to assess response to antiparasitic treatment in the chronic phase. […] The challenge remains of how to move from recommendations to practice implementation, and in that sense, it is crucial to adapt these recommendations to each particular framework at the national level.
  • #1 A Better Way to Diagnose Chagas Disease | Clinical And Molecular Dx
    https://www.labroots.com/trending/clinical-and-molecular-dx/28748/diagnose-chagas-disease?srsltid=AfmBOoqIN-BSY0ZEXMdRiJwKcirgf8rmi8f8B-pex0asdG5DQI15wajd
    Chagas disease is considered a neglected tropical disease; it is caused by a protozoan parasite (Trypanosoma cruzi), which is harbored by many different wild animals in the Americas, including the kissing bug. […] Now, scientists have created a better way to diagnose this infectious disease, which could significantly improve outcomes for patients. […] Since Chagas disease has to be diagnosed and treated early, and before severe complications arise, a good testing method is crucial to effectively controlling the illness. […] Diagnosing Chagas can be challenging because the parasites that cause the disease tend to vary depending on where they live, noted first study author Priscila Silva Grijo Farani, Ph.D., a postdoctoral fellow at The University of Texas at El Paso. […] „Chagas disease is a real conundrum when it comes to diagnosis. Patients in the acute phase typically do not have symptoms when the parasitic load is highest in the bloodstream. But when the symptoms do manifest in the chronic phase, the parasitic load is much lower and harder to detect in blood samples,” Farani explained.
  • #1 A Better Way to Diagnose Chagas Disease | Clinical And Molecular Dx
    https://www.labroots.com/trending/clinical-and-molecular-dx/28748/diagnose-chagas-disease?srsltid=AfmBOoqIN-BSY0ZEXMdRiJwKcirgf8rmi8f8B-pex0asdG5DQI15wajd
    In this study, the investigators compared the test they developed to existing tests for Chagas disease. […] The new method uses magnetic beads that bind to DNA. Once cells in blood samples have been broken open with a chemical treatment, the magnetic beads can be applied to the sample. The beads capture more DNA that is of a higher quality compared to the old method. This way, the new method presents a better, more sensitive detection method. […] „Dr. Farani’s more sensitive approach to DNA extraction represents a significant advancement in Chagas disease diagnostics. Her work has the potential to greatly enhance early detection and improve patient therapeutic outcomes, particularly for those in the chronic phase when accurate diagnosis is most challenging,” said co-corresponding study author Igor Almeida, Ph.D., a UTEP Professor.
  • #1 Researchers Test New, More Reliable Method to Detect Chagas Disease | Today’s Clinical Lab
    https://www.clinicallab.com/researchers-test-new-more-reliable-method-to-detect-chagas-disease-28220
    Farani explained that, compared to the silica columns, the magnetic beads yielded a higher quantity of pure DNA and significantly enhanced the sensitivity of parasite detection in blood samples, making them a more reliable indicator of parasites in the blood. […] This research marks a significant advancement, especially for patients in the chronic phase, where reliable parasite detection remains a major challenge, Farani said. […] „Dr. Faranis more sensitive approach to DNA extraction represents a significant advancement in Chagas disease diagnostics. Her work has the potential to greatly enhance early detection and improve patient therapeutic outcomes, particularly for those in the chronic phase when accurate diagnosis is most challenging,” said Almeida.
  • #1 New PCR Assay for Chagas Disease Diagnosis | Eurofins Viracor
    https://www.eurofins-viracor.com/news-and-events/posts/2025/january/eurofins-viracor-launches-new-quantitative-pcr-assay-for-chagas-disease-t-cruzi-diagnosis/
    New PCR Assay for Chagas Disease Diagnosis […] Eurofins Viracor, LLC a leading provider of specialty diagnostic testing, and part of the global network of Eurofins companies, is pleased to announce the launch of an innovative quantitative PCR assay for the detection of Trypanosoma cruzi (T. cruzi), the parasitic cause of Chagas disease. […] The Chagas (T. cruzi) qPCR test is a crucial tool for the accurate detection of Trypanosoma cruzi infection, a disease that often goes undiagnosed due to its asymptomatic nature in its early stages. […] With an estimated 300,000 people infected with Trypanosoma cruzi in the United States this test is vital for identifying individuals at risk particularly transplant recipients, who may face potential transmission from donor organs, or immunocompromised patients, who are at risk of reactivation of a prior infection. Many infection cases have the potential of going undiagnosed due to the limitations of traditional diagnostic methods. Eurofins Viracor’s new assay addresses this critical gap by providing:
  • #1 New PCR Assay for Chagas Disease Diagnosis | Eurofins Viracor
    https://www.eurofins-viracor.com/news-and-events/posts/2025/january/eurofins-viracor-launches-new-quantitative-pcr-assay-for-chagas-disease-t-cruzi-diagnosis/
    A sensitive, quantitative PCR assay with rapid turnaround times, delivering results within 48 hours of receipt of sample. […] The launch of a quantitative PCR assay for Chagas disease underscores Eurofins Viracor’s commitment to improving diagnostic solutions for underserved conditions. The company believes that, with this assay, healthcare providers can gain a powerful tool to better diagnose, monitor, and manage Chagas disease, ultimately improving patient outcomes. […] The new assay is now available for order from Eurofins Viracor.
  • #1 Accurate diagnosis for Chagas disease | Oswaldo Cruz Institute
    https://www.ioc.fiocruz.br/en/noticias/diagnostico-preciso-para-doenca-de-chagas
    We observed an international mobilization for the development of diagnostic methods and monitoring the effectiveness of therapeutic regimens for Chagas disease through the application of the PCR technique, which is adopted by laboratories around the world. Defining a consensual protocol for the use of molecular testing is essential for the advancement of research and global scientific knowledge in the area. […] For the biologist, the application of PCR in the hospital outpatient routine and in blood banks, assisting in the screening of donors, with the purpose of solving the problem of false-positive serological results and the consequent disposal of uncontaminated blood, would be ways of contain the spread of Chagas disease. […] Another contribution of PCR highlighted by ConstanÅ£a is the potential in monitoring the effectiveness of therapeutic schemes, as it helps in the accuracy of diagnoses and can therefore help in the formation of criteria for controlling the cure of patients. […] The Laboratory of Molecular Biology and Endemic Diseases of the IOC is also preparing a protocol for Real Time PCR, an even more sensitive modality of the method, to diagnose the different lineages of the T. cruzi and enable the monitoring of parasitemia in patients undergoing therapeutic regimens.
  • #1 Chagas Disease Diagnosis with Trypanosoma cruzi-Exclusive Epitopes in GFP
    https://www.mdpi.com/2076-393X/12/9/1029
    Chagas Disease Diagnosis with Trypanosoma cruzi-Exclusive Epitopes in GFP […] Serological tests are critical tools in the fight against infectious disease. They detect antibodies produced during an adaptive immune response against a pathogen with an immunological reagent, whose antibody binding characteristics define the specificity and sensitivity of the assay. […] The period immediately after an infection, the acute phase, is generally asymptomatic. […] After this transition, direct parasitological methods for diagnosis are unreliable and elevate the detection of antibodies, principally IgG, against T. cruzi antigens via serological methods as more appropriate. […] Several immunological tests based on different technological platforms are available for CD diagnosis including indirect hemagglutination assays, indirect immunofluorescence assays, enzyme-linked immunosorbent assays (ELISA), and chemiluminescent assays. […] Currently, the WHO and the Brazilian Ministry of Health recommend the use of two independent serological tests to reach a conclusive diagnosis. […] The nonexistence of a gold standard assay increases the time and cost of diagnosis, which limits the detection of chronically infected individuals. […] While recombinant DNA techniques have expanded our ability to prepare different antigens for use in the immunological diagnosis of CD, major difficulties remain with regard to sensitivity and cross-reactivity, especially with other protozoan parasites such as Leishmania spp. and Trypanosoma rangeli. […] The performance of a serological test is most directly related to the antibody binding characteristics of the defining capture reagent. […] The first deca-epitope protein design, DxCruziV1, proved to be easily expressed in bacteria. Moreover, it displayed 100% sensitivity and 100% specificity, which has been an elusive achievement for immunological reagents to diagnose Chagas disease. […] By performing a spot synthesis analysis, it was possible to observe the effective contribution of each linear epitope to the production of a signal. […] The analytical sensitivity of DxCruziV2 is clearly higher than that of DxCruziV1 and easily meets the recommended target dilution factor of 1:64. […] High-performance immunological reagents for the diagnosis of chronic Chagas disease have been generated through the incorporation of ten T. cruzi-specific epitopes into the loops of the β-barrel structures of fluorescent proteins.
  • #1 Accuracy of Diagnostic Tests for the Detection of Chagas Disease: A Systematic Review and Meta-Analysis
    https://www.mdpi.com/2075-4418/12/11/2752
    This situation reveals the urgent need for the development of new diagnostic tools for disease diagnosis. […] The accurate and sensitive diagnosis of CD is important for effective treatment and the adoption of control measures against the disease. This study found that the ELISA technique showed better diagnostic performance in the chronic and acute phases of CD compared to other serological (HmT and IFAT) and molecular (PCR and qPCR) techniques, suggesting its feasibility to be used for sensitive and specific CD diagnosis.
  • #1 Diagnostic Gaps and Recommendations for Chagas Disease | PATH
    https://www.path.org/our-impact/resources/diagnostic-gaps-chagas-disease/
    PATH identified four use cases for Chagas diagnostics: case diagnosis, congenital case detection, treatment monitoring, and screening of blood and organ donations. Our analysis found that access to and adoption of current tools remain a barrier to their effective use in Chagas disease control efforts in many endemic settings. This may be due in part to insufficient evidence to support their implementation. Additionally, because of the reliance on serologic tests and inadequate markers of active infection, current tools available to detect congenital infections and monitor treatment are not yet sufficient to fully support needs in these use cases. Based on these findings, we offer the following recommendations: […] Establish more standardized policies and practices for Chagas diagnosis and treatment by generating evidence around the efficacy of current tools in diverse settings and building consensus around standards among global and regional stakeholders.
  • #1 Diagnostic Gaps and Recommendations for Chagas Disease | PATH
    https://www.path.org/our-impact/resources/diagnostic-gaps-chagas-disease/
    Develop a point-of-care diagnostic tool to detect congenital infections, which would enable early initiation of treatment and a clear linkage to postnatal care. […] Develop a diagnostic tool to monitor treatment efficacy, which would inform clinical decision-making during treatment and support the development of better drugs.
  • #2 More than a Hundred Years in the Search for an Accurate Diagnosis for Chagas Disease: Current Panorama and Expectations | IntechOpen
    https://www.intechopen.com/chapters/67456
    Chagas disease, or American trypanosomiasis, is a parasitic disease of the Americas. Currently, Chagas disease affects approximately 67 million people worldwide, and the process of urbanization in Latin America and migratory movements from endemic countries have led to Chagas disease being diagnosed in areas where the infection is not endemic. There are several methods for diagnosing Chagas disease. According to the World Health Organization (WHO), chronic Chagas disease diagnosis is based on two serological techniques. To establish a definitive diagnosis, the results must be concordant. In the case of discordances, the WHO proposes repeating serology in a new sample, and if results remain inconclusive, a confirmatory test should be performed. This chapter shows aspects of the diagnosis of Chagas disease, which varies in its sensitivity and specificity, and its use depends on the geographical location, the available resources, and the purpose of the diagnosis.
  • #2 SciELO Brazil – Parasitological, serological and molecular diagnosis of acute and chronic Chagas disease: from field to laboratory Parasitological, serological and molecular diagnosis of acute and chronic Chagas disease: from field to laboratory
    https://www.scielo.br/j/mioc/a/WmNV3ywZFmXZfvPHmX4JzCx/
    There is no consensus on the diagnostic algorithms for many scenarios of Trypanosoma cruzi infection, which hinders the establishment of governmental guidelines in endemic and non-endemic countries. […] In the acute phase, parasitological methods are currently employed, and standardised surrogate molecular tests are being introduced to provide higher sensitivity and less operator-dependence. […] In the chronic phase, IgG-based serological assays are currently used, but if a single assay does not reach the required accuracy, PAHO/WHO recommends at least two immunological tests with different technical principles. […] Specific algorithms are applied to diagnose congenital infection, screen blood and organ donors or conduct epidemiological surveys. […] Detecting Chagas disease reactivation in immunosuppressed individuals is an area of increasing interest.
  • #2 Clinical Testing and Diagnosis for Chagas Disease | Parasites – American Trypanosomiasis (also known as Chagas Disease) | CDC
    https://www.cdc.gov/chagas/hcp/diagnosis-testing/index.html
    Acute Chagas disease can be identified by spotting parasites in blood using microscopy. […] In the acute phase of infection, healthcare providers might observe parasites circulating in the blood. They can diagnose Chagas disease by detecting these parasites in a blood smear through microscopic examination. This involves preparing and staining both thick and thin blood smears to visualize the parasites. […] To diagnose chronic Chagas disease, healthcare providers should assess the patient’s clinical findings and infection likelihood, including factors like a history of residence in a Chagas-prevalent area. Typically, this diagnosis requires testing for parasite-specific antibodies. […] Healthcare providers diagnose acute Chagas infections by identifying trypomastigotes in blood using microscopy.
  • #2 Clinical Testing and Diagnosis for Chagas Disease | Parasites – American Trypanosomiasis (also known as Chagas Disease) | CDC
    https://www.cdc.gov/chagas/hcp/diagnosis-testing/index.html
    For chronic Chagas disease, healthcare providers detect antibodies against the parasite using serologic tests. […] No single test is sufficiently sensitive and specific for diagnosis. […] Use two or more tests that detect antibodies to different antigens. […] Common techniques include enzyme-linked immunosorbent assay (ELISA) and immunofluorescent antibody test (IFA). […] Assessing the patient’s history for infection risks is also helpful.
  • #2 The use of rapid diagnostic tests for chronic Chagas disease: An expert meeting report | PLOS Neglected Tropical Diseases
    https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0012340
    Chagas disease, caused by Trypanosoma cruzi, affects millions of people globally and is associated with significant underdiagnosis and undertreatment. Current diagnostic algorithms face challenges in remote regions. We aimed to review the potential of rapid diagnostic tests (RDTs) for screening or diagnosing chronic Chagas disease in endemic areas. […] The results indicate that RDTs play a crucial role in surveillance and screening, although limitations in sensitivity and specificity exist. […] Despite these challenges, RDTs present a promising avenue for improving Chagas disease diagnosis in resource-limited settings. Future research and a collaborative approach are deemed essential for effective implementation. […] In line with international recommendations from the Pan American Health Organization (PAHO), the diagnosis of T. cruzi infection in the chronic phase of Chagas disease is made using serological tests. WHO and PAHO strongly recommend the use of at least 2 serological tests representing different methodological principles or antigens: one with high sensitivity (for instance, immunoenzymatic test referred to as the enzyme-linked immunosorbent assay) and one with high specificity (for instance, indirect hemagglutination). […] Despite its effectiveness, this algorithm requires time, laboratory infrastructure, and expertise often unavailable in many rural and hard-to-reach regions, resulting in the underdiagnosis and underreporting of infected individuals.
  • #2 More than a Hundred Years in the Search for an Accurate Diagnosis for Chagas Disease: Current Panorama and Expectations | IntechOpen
    https://www.intechopen.com/chapters/67456
    Diagnostic methods for T. cruzi can be included in three main groups: parasitological, serological, and molecular. Parasitological methods aim to visualize the presence of parasites, and their sensitivity varies depending on the stage of infection. For diagnosis of the disease in the phase where the parasitemia is very low, immunological methods (serological) are based primarily on the search for G antibodies (IgG) anti-T. cruzi in the blood of patients and their colorimetric reaction visible in the case that the blood of the patients contains the antibodies. The most commonly used methods are ELISA test (sensitivity = 94-100%, specificity = 96-100%), indirect hemagglutination (HAI, sensitivity = 88-99%, specificity = 96-100%), and indirect immunofluorescence (IFI, sensitivity = 98%, specificity = 98%). Despite being highly sensitive and specific, serological tests can have some cross-reactivity.
  • #2 Center of Excellence for Chagas Disease | Slymar, CA | Chagas Diagnosis
    https://chagasus.org/diagnosis/
    Different strains of T. cruzi, differential immune responses to infection, and variable levels of antibodies during the chronic phase can make Chagas disease challenging to detect. There is no single gold standard assay. Rather, the World Health Organization recommends diagnosis of Chagas disease with two serologic assays of different types.
  • #2 Molecular diagnosis of Chagas disease: a systematic review and meta-analysis | Infectious Diseases of Poverty | Full Text
    https://idpjournal.biomedcentral.com/articles/10.1186/s40249-023-01143-7
    CD diagnosis depends on the phase (acute or chronic) in which a patient is found to be infected. […] For decades, serology has been a useful tool in the diagnosis of the chronic phase in CD, detecting anti-T. cruzi IgG antibodies. […] In recent years, PCR (polymerase chain reaction) has been the predominant molecular technique used. PCR has proven useful during acute-phase or chronic-phase reactivations due to its greater sensitivity compared to microscopy methods. […] The viability of PCR use during the chronic phase is debatable because it yields a positive result in 40-70% of patients who have previously been diagnosed by conventional serological methods, depending on the degree of parasitemia, sample volume, DNA purification, target region, study population characteristics, and great genetic variability between the parasites discrete typing units (DTUs).
  • #2 CDC – DPDx – American Trypanosomiasis
    https://www.cdc.gov/dpdx/trypanosomiasisamerican/index.html
    Molecular diagnosis of Chagas disease is performed for cases of suspected acute infection (including transfusion or transplant transmission), congenital Chagas disease, and for monitoring of suspected laboratory exposures. For chronic Chagas disease, serology is generally most appropriate, although molecular detection may be performed for re-activated cases associated with immunosuppression. […] At CDC molecular detection of T. cruzi DNA is performed using a combination of two real-time PCR assays (TCZ and MNC). Acceptable specimen types are EDTA blood (minimum of 2.2 ml), heart biopsy tissue (in saline or paraffin-embedded) and, in cases of suspected central nervous system involvement, CSF.
  • #2 The use of rapid diagnostic tests for chronic Chagas disease: An expert meeting report | PLOS Neglected Tropical Diseases
    https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0012340
    Over the past 2 decades, commercial development has yielded rapid diagnostic tests (RDTs) designed for detecting T. cruzi-specific immunoglobulin G (IgG). RDTs are easy-to-use point-of-care diagnostic tools that typically provide results within 30 minutes. […] However, it is important to note that, at present, RDTs are recommended only for screening purposes and not for individual diagnosis. Serological confirmation of a patient is mandatory, potentially causing a delay in initiating treatment when recommended. […] The objective of the present discussion was to review the existing evidence supporting the use of RDTs for screening or diagnosing chronic Chagas disease. Additionally, the aim was to discuss the implications of eventually adopting and implementing these tests as a strategy for diagnosing Chagas disease, considering their current reported accuracy and sustainability as a public health response in Latin America.
  • #2 Chagas Disease Diagnosis in Newborns – ISGLOBAL
    https://www.isglobal.org/en/-/diagnostico-de-chagas-en-recien-nacidos
    The LAMP molecular diagnostic test, coupled with a modified 3D printer to extract DNA, has a sensitivity comparable to PCR, and can be used in laboratories with limited resources. […] An innovative test that combines a DNA extraction system inspired by a modified 3D printer (PrintrLab) with loop-mediated isothermal molecular amplification (LAMP) could be used to detect T. cruzi infection -responsible for Chagas disease- in newborns. […] Early detection of the parasite in women and newborns is therefore a public health priority. […] The problem is the lack of simple, rapid and reliable tests. […] In endemic regions, it would be very useful to have a simple, rapid and sensitive test to detect the parasite in newborns, when treatment is most effective. […] This shows that the sensitivity of PrintrLab-LAMP is higher than that of microscopy and almost equal to that of PCR.
  • #2 Chagas Disease Diagnosis in Newborns – ISGLOBAL
    https://www.isglobal.org/en/-/diagnostico-de-chagas-en-recien-nacidos
    The advantage is that PrintrLab should be cheaper than PCR and requires minimal infrastructure. […] Following the country’s guidelines for diagnosis and treatment of congenital Chagas disease, all infected newborns were treated and cured, highlighting the importance of early detection and treatment. […] The research team points out that this was a proof of concept to demonstrate the feasibility of the PrintrLab-LAMP test, and that it now needs to be tested on a larger scale and in a larger number of centres.
  • #2 Trypanosoma cruzi – Chagas Disease | Choose the Right Test
    https://arupconsult.com/content/trypanosoma-cruzi
    Therefore, during the chronic phase, serology is necessary to diagnose Chagas disease. […] Laboratory testing for Chagas disease is indicated in individuals who are at risk when clinical findings point to acute- or chronic-phase infection. […] Accurate diagnosis of Chagas disease requires the use of appropriate testing for the suspected stage of infection (either acute or chronic), which corresponds to detectable parasitemia. […] Blood smear and PCR testing may be used when acute-phase Chagas disease is suspected, whereas serology is preferred to detect chronic-phase infection. […] Because no single serologic test is adequately sensitive or specific to diagnose Chagas disease, two or more serologic methods are needed to confirm infection. […] Selective screening is recommended for both organ transplant recipients and living donors who are at risk for Chagas disease to identify the possibility of transmission or reactivation and mitigate potential serious complications. […] The American Society of Transplantation (AST) recommends dual-method serologic testing to screen for chronic Chagas infection in any transplant candidate who may be at risk for the disease.
  • #2 Diagnosis and clinical management of Chagas disease | RRTM
    https://www.dovepress.com/diagnosis-and-clinical-management-of-chagas-disease-an-increasing-chal-peer-reviewed-fulltext-article-RRTM
    Serology is used for primary diagnosis in the indeterminate or chronic stage. […] In untreated seropositive individuals, PCR should also be requested to detect and establish the level of parasitemia, particularly relevant in pregnant women, for whom detectable DNA carries an increased risk of mother-to-child transmission. […] The most commonly used approach is the screening with serology of at-risk pregnant women, aiming to diagnose infection in the newborn and, if present, offer treatment, which is highly successful in young children. […] Antenatal screening is a clear recommendation from the PAHO and the WHO, also in non-endemic countries. […] The implementation of antenatal screening programs requires the engagement from professionals and mothers. […] Detecting cases of infection by T. cruzi in this setting requires a high level of clinical suspicion, awareness of the variety of clinical presentations and prospective laboratory monitoring, as there is little guidance out of endemic countries. […] The risk of acquiring T. cruzi infection after transfusion of an infected unit is estimated to be 10 to 25%. […] Serological screening of blood donations is practised extensively in endemic Latin American countries.
  • #2 Molecular diagnosis of Chagas disease: a systematic review and meta-analysis | Infectious Diseases of Poverty | Full Text
    https://idpjournal.biomedcentral.com/articles/10.1186/s40249-023-01143-7
    The complexity of the Chagas disease and its phases is impossible to have a unique test for both phases and a lot of different epidemiological scenarios. Currently, serology is the reference standard technique; occasionally, results are inconclusive, and a different diagnostic technique is needed. Some guidelines recommend molecular testing. A systematic review and meta-analysis of available molecular tools/techniques for the diagnosis of Chagas disease was performed to measure their heterogeneity and efficacy in detecting Trypanosoma cruzi infection in blood samples. […] The results described in this meta-analysis (qualitative and quantitative analyses) do not allow the selection of the optimal protocol of molecular method for the study of Trypanosoma cruzi infection in any of its phases, among other reasons due to the complexity of this infection. Continuous analysis and optimization of the different molecular techniques is crucial to implement this efficient diagnosis in endemic areas.
  • #2 Recommendations for Screening and Diagnosis of Chagas Disease in the United States
    https://pmc.ncbi.nlm.nih.gov/articles/PMC9071346/
    Chagas disease affects an estimated 326,000-347,000 people in the United States and is severely underdiagnosed. Lack of awareness and clarity regarding screening and diagnosis is a key barrier. This article provides straightforward recommendations, with the goal of simplifying identification and testing of people at risk for US healthcare providers. […] Individuals who were born or resided for prolonged time periods in endemic countries of Mexico and Central and South America should be tested for Trypanosoma cruzi infection, and family members of people who test positive should be screened. […] Diagnostic testing for chronic T. cruzi infection should be conducted using 2 distinct assays. […] Increasing provider-directed screening for T. cruzi infection is key to addressing this neglected public health challenge in the United States.
  • #2 Center of Excellence for Chagas Disease | Slymar, CA | Chagas Diagnosis
    https://chagasus.org/diagnosis/
    Diagnosis of Chagas disease differs depending on the phase of the disease. It is very rare to encounter acute cases, since acute symptoms are easily confused with flu-like illnesses and seldom associated with triatomines. Diagnosis typically occurs during the chronic phase. […] It is estimated that 99% of patients are unaware they have the infection, which is why we recommend routine screening for adults who have lived in endemic Latin American countries. Other groups, such as people who spend significant time camping/hunting/working outdoors in endemic states of the southern U.S. might also benefit from screening. […] In the acute phase, which lasts 2-4 weeks after the initial infection, Trypanosoma cruzi can be observed swimming freely in the bloodstream. Diagnosis can be made by observing the parasite under a microscope in a blood smear.
  • #2 Chagas Disease: Adult and Adolescent OIs | NIH
    https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/chagas-disease
    Chagas disease (American trypanosomiasis) is caused by the protozoan parasite Trypanosoma cruzi. It is transmitted to humans by infected triatomine bugs (kissing bugs), and less commonly by transfusion, organ transplant, from mother to infant, and, in rare instances, by ingestion of contaminated food or drink. […] Screening with serological testing is recommended for all individuals who have lived in Mexico or Central or South America for greater than 6 months. […] Most persons infected with T. cruzi are in the chronic phase and are typically unaware of their infection. Screening for infection to identify persons with the indeterminate or early clinical forms of chronic Chagas disease is important to identify those who might benefit from antiparasitic treatment and counseling regarding potential transmission of T. cruzi to others (e.g., blood donation, organ donation). This is particularly important for people with HIV because of the risk of reactivation disease.
  • #2
    https://www.gov.uk/guidance/chagas-disease-migrant-health-guide
    Offer serological testing to pregnant women who are migrants from Latin America. While treatment of Chagas during pregnancy is contraindicated, identification is important to detect and treat congenital infection. Treatment of infants is highlight effective and well tolerated. Failure to identify and treat infected infants poses risk of morbidity and premature mortality from chronic Chagas later in life. […] Offer screening to immunosuppressed individuals (particularly those with HIV infection, undergoing transplantation or cancer chemotherapy) as they may be at risk of reactivation of infection and associated complications.
  • #2 Chagas disease – Diagnosis & treatment – Mayo Clinic
    https://www.mayoclinic.org/diseases-conditions/chagas-disease/diagnosis-treatment/drc-20356218
    Your healthcare professional does a physical exam, asking about your symptoms and anything that put you at risk of Chagas disease. If you have symptoms of Chagas disease, two or more blood tests can confirm the diagnosis. […] If you’re diagnosed with Chagas disease, you’re likely to have more tests. These tests can show whether the disease has become chronic and caused heart or digestive complications. Tests may include: […] Treatment for Chagas disease is to kill the parasite and ease symptoms. […] For Chagas disease, some basic questions to ask include: […] What tests do I need? […] Your healthcare professional is likely to ask questions, including: […] What, if anything, makes your symptoms worse? Have you lived or traveled anywhere, such as Mexico, where the triatomine bug or Chagas disease is common?
  • #2 A Better Way to Diagnose Chagas Disease | Clinical And Molecular Dx
    https://www.labroots.com/trending/clinical-and-molecular-dx/28748/diagnose-chagas-disease?srsltid=AfmBOoqIN-BSY0ZEXMdRiJwKcirgf8rmi8f8B-pex0asdG5DQI15wajd
    Chagas disease is considered a neglected tropical disease; it is caused by a protozoan parasite (Trypanosoma cruzi), which is harbored by many different wild animals in the Americas, including the kissing bug. […] Now, scientists have created a better way to diagnose this infectious disease, which could significantly improve outcomes for patients. […] Since Chagas disease has to be diagnosed and treated early, and before severe complications arise, a good testing method is crucial to effectively controlling the illness. […] Diagnosing Chagas can be challenging because the parasites that cause the disease tend to vary depending on where they live, noted first study author Priscila Silva Grijo Farani, Ph.D., a postdoctoral fellow at The University of Texas at El Paso. […] „Chagas disease is a real conundrum when it comes to diagnosis. Patients in the acute phase typically do not have symptoms when the parasitic load is highest in the bloodstream. But when the symptoms do manifest in the chronic phase, the parasitic load is much lower and harder to detect in blood samples,” Farani explained.
  • #2 New PCR Assay for Chagas Disease Diagnosis | Eurofins Viracor
    https://www.eurofins-viracor.com/news-and-events/posts/2025/january/eurofins-viracor-launches-new-quantitative-pcr-assay-for-chagas-disease-t-cruzi-diagnosis/
    New PCR Assay for Chagas Disease Diagnosis […] Eurofins Viracor, LLC a leading provider of specialty diagnostic testing, and part of the global network of Eurofins companies, is pleased to announce the launch of an innovative quantitative PCR assay for the detection of Trypanosoma cruzi (T. cruzi), the parasitic cause of Chagas disease. […] The Chagas (T. cruzi) qPCR test is a crucial tool for the accurate detection of Trypanosoma cruzi infection, a disease that often goes undiagnosed due to its asymptomatic nature in its early stages. […] With an estimated 300,000 people infected with Trypanosoma cruzi in the United States this test is vital for identifying individuals at risk particularly transplant recipients, who may face potential transmission from donor organs, or immunocompromised patients, who are at risk of reactivation of a prior infection. Many infection cases have the potential of going undiagnosed due to the limitations of traditional diagnostic methods. Eurofins Viracor’s new assay addresses this critical gap by providing:
  • #2 Chagas Disease Diagnosis with Trypanosoma cruzi-Exclusive Epitopes in GFP
    https://www.mdpi.com/2076-393X/12/9/1029
    Chagas Disease Diagnosis with Trypanosoma cruzi-Exclusive Epitopes in GFP […] Serological tests are critical tools in the fight against infectious disease. They detect antibodies produced during an adaptive immune response against a pathogen with an immunological reagent, whose antibody binding characteristics define the specificity and sensitivity of the assay. […] The period immediately after an infection, the acute phase, is generally asymptomatic. […] After this transition, direct parasitological methods for diagnosis are unreliable and elevate the detection of antibodies, principally IgG, against T. cruzi antigens via serological methods as more appropriate. […] Several immunological tests based on different technological platforms are available for CD diagnosis including indirect hemagglutination assays, indirect immunofluorescence assays, enzyme-linked immunosorbent assays (ELISA), and chemiluminescent assays. […] Currently, the WHO and the Brazilian Ministry of Health recommend the use of two independent serological tests to reach a conclusive diagnosis. […] The nonexistence of a gold standard assay increases the time and cost of diagnosis, which limits the detection of chronically infected individuals. […] While recombinant DNA techniques have expanded our ability to prepare different antigens for use in the immunological diagnosis of CD, major difficulties remain with regard to sensitivity and cross-reactivity, especially with other protozoan parasites such as Leishmania spp. and Trypanosoma rangeli. […] The performance of a serological test is most directly related to the antibody binding characteristics of the defining capture reagent. […] The first deca-epitope protein design, DxCruziV1, proved to be easily expressed in bacteria. Moreover, it displayed 100% sensitivity and 100% specificity, which has been an elusive achievement for immunological reagents to diagnose Chagas disease. […] By performing a spot synthesis analysis, it was possible to observe the effective contribution of each linear epitope to the production of a signal. […] The analytical sensitivity of DxCruziV2 is clearly higher than that of DxCruziV1 and easily meets the recommended target dilution factor of 1:64. […] High-performance immunological reagents for the diagnosis of chronic Chagas disease have been generated through the incorporation of ten T. cruzi-specific epitopes into the loops of the β-barrel structures of fluorescent proteins.
  • #2 Accuracy of Diagnostic Tests for the Detection of Chagas Disease: A Systematic Review and Meta-Analysis
    https://www.mdpi.com/2075-4418/12/11/2752
    This situation reveals the urgent need for the development of new diagnostic tools for disease diagnosis. […] The accurate and sensitive diagnosis of CD is important for effective treatment and the adoption of control measures against the disease. This study found that the ELISA technique showed better diagnostic performance in the chronic and acute phases of CD compared to other serological (HmT and IFAT) and molecular (PCR and qPCR) techniques, suggesting its feasibility to be used for sensitive and specific CD diagnosis.
  • #2 Diagnostic Gaps and Recommendations for Chagas Disease | PATH
    https://www.path.org/our-impact/resources/diagnostic-gaps-chagas-disease/
    PATH identified four use cases for Chagas diagnostics: case diagnosis, congenital case detection, treatment monitoring, and screening of blood and organ donations. Our analysis found that access to and adoption of current tools remain a barrier to their effective use in Chagas disease control efforts in many endemic settings. This may be due in part to insufficient evidence to support their implementation. Additionally, because of the reliance on serologic tests and inadequate markers of active infection, current tools available to detect congenital infections and monitor treatment are not yet sufficient to fully support needs in these use cases. Based on these findings, we offer the following recommendations: […] Establish more standardized policies and practices for Chagas diagnosis and treatment by generating evidence around the efficacy of current tools in diverse settings and building consensus around standards among global and regional stakeholders.
  • #3 Chagas disease – Wikipedia
    https://en.wikipedia.org/wiki/Chagas_disease
    Chagas disease is diagnosed by finding the parasite in the blood using a microscope or detecting its DNA by polymerase chain reaction. […] Chronic disease is diagnosed by finding antibodies for T. cruzi in the blood. […] During the acute phase of infection, it can be detected by microscopic examination of fresh anticoagulated blood, or its buffy coat, for motile parasites; or by preparation of thin and thick blood smears stained with Giemsa, for direct visualization of parasites. […] In chronic Chagas disease, the concentration of parasites in the blood is too low to be reliably detected by microscopy or PCR, so the diagnosis is usually made using serological tests, which detect immunoglobulin G antibodies against T. cruzi in the blood. […] Two positive serology results, using different test methods, are required to confirm the diagnosis.
  • #3 More than a Hundred Years in the Search for an Accurate Diagnosis for Chagas Disease: Current Panorama and Expectations | IntechOpen
    https://www.intechopen.com/chapters/67456
    Diagnostic methods for T. cruzi can be included in three main groups: parasitological, serological, and molecular. Parasitological methods aim to visualize the presence of parasites, and their sensitivity varies depending on the stage of infection. For diagnosis of the disease in the phase where the parasitemia is very low, immunological methods (serological) are based primarily on the search for G antibodies (IgG) anti-T. cruzi in the blood of patients and their colorimetric reaction visible in the case that the blood of the patients contains the antibodies. The most commonly used methods are ELISA test (sensitivity = 94-100%, specificity = 96-100%), indirect hemagglutination (HAI, sensitivity = 88-99%, specificity = 96-100%), and indirect immunofluorescence (IFI, sensitivity = 98%, specificity = 98%). Despite being highly sensitive and specific, serological tests can have some cross-reactivity.
  • #3 Molecular diagnosis of Chagas disease: a systematic review and meta-analysis | Infectious Diseases of Poverty | Full Text
    https://idpjournal.biomedcentral.com/articles/10.1186/s40249-023-01143-7
    CD diagnosis depends on the phase (acute or chronic) in which a patient is found to be infected. […] For decades, serology has been a useful tool in the diagnosis of the chronic phase in CD, detecting anti-T. cruzi IgG antibodies. […] In recent years, PCR (polymerase chain reaction) has been the predominant molecular technique used. PCR has proven useful during acute-phase or chronic-phase reactivations due to its greater sensitivity compared to microscopy methods. […] The viability of PCR use during the chronic phase is debatable because it yields a positive result in 40-70% of patients who have previously been diagnosed by conventional serological methods, depending on the degree of parasitemia, sample volume, DNA purification, target region, study population characteristics, and great genetic variability between the parasites discrete typing units (DTUs).
  • #3 CDC – DPDx – American Trypanosomiasis
    https://www.cdc.gov/dpdx/trypanosomiasisamerican/index.html
    Molecular diagnosis of Chagas disease is performed for cases of suspected acute infection (including transfusion or transplant transmission), congenital Chagas disease, and for monitoring of suspected laboratory exposures. For chronic Chagas disease, serology is generally most appropriate, although molecular detection may be performed for re-activated cases associated with immunosuppression. […] At CDC molecular detection of T. cruzi DNA is performed using a combination of two real-time PCR assays (TCZ and MNC). Acceptable specimen types are EDTA blood (minimum of 2.2 ml), heart biopsy tissue (in saline or paraffin-embedded) and, in cases of suspected central nervous system involvement, CSF.
  • #3 Chagas Disease Diagnosis in Newborns – ISGLOBAL
    https://www.isglobal.org/en/-/diagnostico-de-chagas-en-recien-nacidos
    The LAMP molecular diagnostic test, coupled with a modified 3D printer to extract DNA, has a sensitivity comparable to PCR, and can be used in laboratories with limited resources. […] An innovative test that combines a DNA extraction system inspired by a modified 3D printer (PrintrLab) with loop-mediated isothermal molecular amplification (LAMP) could be used to detect T. cruzi infection -responsible for Chagas disease- in newborns. […] Early detection of the parasite in women and newborns is therefore a public health priority. […] The problem is the lack of simple, rapid and reliable tests. […] In endemic regions, it would be very useful to have a simple, rapid and sensitive test to detect the parasite in newborns, when treatment is most effective. […] This shows that the sensitivity of PrintrLab-LAMP is higher than that of microscopy and almost equal to that of PCR.
  • #3 Recommendations for Screening and Diagnosis of Chagas Disease in the United States
    https://pmc.ncbi.nlm.nih.gov/articles/PMC9071346/
    Chagas disease affects an estimated 326,000-347,000 people in the United States and is severely underdiagnosed. Lack of awareness and clarity regarding screening and diagnosis is a key barrier. This article provides straightforward recommendations, with the goal of simplifying identification and testing of people at risk for US healthcare providers. […] Individuals who were born or resided for prolonged time periods in endemic countries of Mexico and Central and South America should be tested for Trypanosoma cruzi infection, and family members of people who test positive should be screened. […] Diagnostic testing for chronic T. cruzi infection should be conducted using 2 distinct assays. […] Increasing provider-directed screening for T. cruzi infection is key to addressing this neglected public health challenge in the United States.
  • #3 Chagas disease – Diagnosis & treatment – Mayo Clinic
    https://www.mayoclinic.org/diseases-conditions/chagas-disease/diagnosis-treatment/drc-20356218
    Your healthcare professional does a physical exam, asking about your symptoms and anything that put you at risk of Chagas disease. If you have symptoms of Chagas disease, two or more blood tests can confirm the diagnosis. […] If you’re diagnosed with Chagas disease, you’re likely to have more tests. These tests can show whether the disease has become chronic and caused heart or digestive complications. Tests may include: […] Treatment for Chagas disease is to kill the parasite and ease symptoms. […] For Chagas disease, some basic questions to ask include: […] What tests do I need? […] Your healthcare professional is likely to ask questions, including: […] What, if anything, makes your symptoms worse? Have you lived or traveled anywhere, such as Mexico, where the triatomine bug or Chagas disease is common?
  • #3 A Better Way to Diagnose Chagas Disease | Clinical And Molecular Dx
    https://www.labroots.com/trending/clinical-and-molecular-dx/28748/diagnose-chagas-disease?srsltid=AfmBOoqIN-BSY0ZEXMdRiJwKcirgf8rmi8f8B-pex0asdG5DQI15wajd
    Chagas disease is considered a neglected tropical disease; it is caused by a protozoan parasite (Trypanosoma cruzi), which is harbored by many different wild animals in the Americas, including the kissing bug. […] Now, scientists have created a better way to diagnose this infectious disease, which could significantly improve outcomes for patients. […] Since Chagas disease has to be diagnosed and treated early, and before severe complications arise, a good testing method is crucial to effectively controlling the illness. […] Diagnosing Chagas can be challenging because the parasites that cause the disease tend to vary depending on where they live, noted first study author Priscila Silva Grijo Farani, Ph.D., a postdoctoral fellow at The University of Texas at El Paso. […] „Chagas disease is a real conundrum when it comes to diagnosis. Patients in the acute phase typically do not have symptoms when the parasitic load is highest in the bloodstream. But when the symptoms do manifest in the chronic phase, the parasitic load is much lower and harder to detect in blood samples,” Farani explained.
  • #3 Accuracy of Diagnostic Tests for the Detection of Chagas Disease: A Systematic Review and Meta-Analysis
    https://www.mdpi.com/2075-4418/12/11/2752
    This situation reveals the urgent need for the development of new diagnostic tools for disease diagnosis. […] The accurate and sensitive diagnosis of CD is important for effective treatment and the adoption of control measures against the disease. This study found that the ELISA technique showed better diagnostic performance in the chronic and acute phases of CD compared to other serological (HmT and IFAT) and molecular (PCR and qPCR) techniques, suggesting its feasibility to be used for sensitive and specific CD diagnosis.
  • #4 Chagas Disease Diagnosis in Newborns – ISGLOBAL
    https://www.isglobal.org/en/-/diagnostico-de-chagas-en-recien-nacidos
    The LAMP molecular diagnostic test, coupled with a modified 3D printer to extract DNA, has a sensitivity comparable to PCR, and can be used in laboratories with limited resources. […] An innovative test that combines a DNA extraction system inspired by a modified 3D printer (PrintrLab) with loop-mediated isothermal molecular amplification (LAMP) could be used to detect T. cruzi infection -responsible for Chagas disease- in newborns. […] Early detection of the parasite in women and newborns is therefore a public health priority. […] The problem is the lack of simple, rapid and reliable tests. […] In endemic regions, it would be very useful to have a simple, rapid and sensitive test to detect the parasite in newborns, when treatment is most effective. […] This shows that the sensitivity of PrintrLab-LAMP is higher than that of microscopy and almost equal to that of PCR.