WHO comparative evaluation of serologic assays for Chagas disease

Otani, Márcia M.; Vinelli, Elizabeth; Kirchhoff, Louis V.; Pozo, Ana del; Sands, Anita; Vercauteren, G.; Sabino, Éster Cerdeira

doi:10.1111/j.1537-2995.2009.02107.x

Cited by 137 publications

(133 citation statements)

References 13 publications

(13 reference statements)

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“…As shown by the Technical Note N°03/06 from the Brazilian Health Ministry, 19 the ELISA Chagas III showed 99.0% sensibility and 98.0% Sp. Otani and others 25 deduced the same conclusion by showing 99.4% sensibility and 99.6% Sp. Remesar and others 26 used latent class analysis to reach 95.6% Se and 99.8% Sp.…”

Section: Discussionsupporting

confidence: 58%

“…These data are in good agreement with others. 13,14,25,30 In our hands, 5.5% of the unrelated diseases specimens were incorrectly classified as Chagas disease (false positive) and 4.1% were deemed inconclusive. As expected for a test that uses recombinant antigens, the cross-reactivity to leishmaniasis was less frequent with the Imuno-ELISA Chagas.…”

Section: Discussionmentioning

confidence: 96%

“…In the past years, it has been repeatedly reported that chronic Chagas disease is commonly diagnosed by a wide variety of serologic assays that can lead to false-positive results or, perhaps more importantly, failure to detect true positives. [23][24][25] Total or semipurified homogenate of T. cruzi as well as recombinant or chimeric proteins were used as antigen, introducing a source of variability in the final product that can lead to controversial results. For this reason, it is evident the need to identify an optimal antigenic reagent for obtaining an accurate diagnosis.…”

Section: Discussionmentioning

confidence: 99%

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Chronic Chagas Disease Diagnosis: A Comparative Performance of Commercial Enzyme Immunoassay Tests

Santos¹,

Souza²,

Barros³

et al. 2016

The American Journal of Tropical Medicine and Hygiene

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Abstract. There is a significant heterogeneity in reported performance of serological assays for Chagas disease diagnosis. The conventional serology testing in laboratory diagnosis and in blood banks is unsatisfactory because of a high number of inconclusive and misclassified results. We aimed to assess the quality of four commercially available enzymelinked immunosorbent assay tests for their ability to detect Trypanosoma cruzi antibodies in 685 sera samples. Crossreactivity was assessed by using 748 sera from patients with unrelated diseases. Initially, we found that the reactivity index against T. cruzi antigen was statistically higher in sera from Chagas disease patients compared with those from non-chagasic patients, supporting the notion that all evaluated tests have a good discriminatory ability toward the diagnosis of T. cruzi infection in patients in the chronic phase of the disease. Although all tests were similarly sensitive for diagnosing T. cruzi infection, there were significant variations in terms of specificity and cross-reactivity among them. Indeed, we obtained divergent results when testing sera from patient with unrelated diseases, particularly leishmaniasis, with the levels of cross-reactivity being higher in tests using whole T. cruzi extracts compared with those using recombinant proteins. Our data suggest that all four tests may be used for the laboratory diagnosis and routine blood screening diagnose for Chagas disease. We also emphasize that, despite their general good performance, caution is needed when analyzing the results when these tests are performed in areas where other diseases, particularly leishmaniasis, are endemic.

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Section: Discussionsupporting

confidence: 58%

Section: Discussionmentioning

confidence: 96%

Section: Discussionmentioning

confidence: 99%

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Chronic Chagas Disease Diagnosis: A Comparative Performance of Commercial Enzyme Immunoassay Tests

Santos¹,

Souza²,

Barros³

et al. 2016

The American Journal of Tropical Medicine and Hygiene

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“…Entre las múltiples ventajas de la utilización del ELISA Chagas test IICS V.1 está su alta sensibilidad y especificidad 97% y 99% respectivamente evidenciado en un estudio realizado por la Fundação Pró-Sangue/Hemocentro de São Paulo, Brasil en donde se comparó varios kits provenientes de países de América Latina, con sueros caracterizados positivos y negativos por distintos métodos (18), más la garantía de un suministro continúo dado que es de producción local, debemos destacar también que pueden ser utilizados en trabajos de campo, donde no necesita de instrumentación y las lecturas pueden realizarse a simple vista.…”

Section: Elisa Chagas Test Iics V1 Evaluation For the Diagnosis Of Cunclassified

Desempeño del Kit ELISA Chagas IICS V.1 para el diagnóstico de la enfermedad de Chagas

Aria

Acosta

Guillén

et al. 2016

Mem. Inst. Investig. Cienc. Salud

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En Paraguay, el tamizaje serológico para la enfermedad de Chagas en bancos de sangre es necesario, por lo cual es importante un método diagnóstico con alta sensibilidad. El ELISA Chagas test IICS V.1 es un ELISA indirecto sensibilizados con antígeno soluble de epimastigote de T.cruzi de la cepa Ypsilon. El objetivo del presente trabajo fue evaluar el desempeño del ELISA Chagas test IICS V.1 en comparación con kits comerciales, ademásanalizar los resultados de la evaluación externa e interna de calidad del kit. En este estudio observacional de prueba diagnóstica se analizaron 56 muestras de suerospositivos y negativos para antígenos de Trypanosoma cruzi, testados por el ELISA BiosChile, obteniéndose una concordancia excelente entre el ELISA Chagas test IICS V.1y los kits comerciales: Chagatest ELISA-Wiener, con Índice kappa: 0,89 IC de 95% (0,76-1) y Test ELISA para Chagas III-Grupo BiosChile con Índice kappa: 0,92 IC 95% (0,82-1).En la evaluación externa de calidad realizada por la Fundação Pró-Sangue/Hemocentro de São Paulo, Brasil en el periodo 2001 al 2012 se analizaron 450 muestras: 372 negativas y 78 positivas para T. cruzi, obteniéndose en dicha evaluación la calificación "A" que indica ausencia de falsos positivos y negativos. Además, en el mismo periodo los valores del control interno se encontraron dentro del rango permitido de ±2DS. Los resultados obtenidos en el estudio demuestran la alta calidad de este test de producción nacional, que sumado al bajo costo del mismo, pueden ser utilizados en trabajos de campo, donde no necesita de instrumentación y las lecturas pueden realizarse a simple vista, constituyendo una herramienta válida y útil para el apoyo al diagnóstico de la enfermedad de Chagas.Palabras claves: Chagas, T. cruzi, programa de evaluación, control interno. ELISA Chagas test IICS V.1 evaluation for the diagnosis of Chagas disease A B S T R A C TIn Paraguay, the serological screening for Chagas disease is mandatory in pregnant women and blood banks, therefore a high sensitivity diagnostic method is required. The aim of this study was to evaluate the ELISA Chagas test IICS V.1 by comparison with commercial kits and to analyze the external and internal quality evaluation results. In this descriptive observational study, 56 seropositive and seronegative to Trypanosoma cruzi samples were analyzed, obtaining an excellent concordance between the ELISA Chagas test IICS V.1 and these commercial kits: Chagatest Chile (kappa index: 0.92).In the external quality assessment carried out by the Fundação Pró-Sangue /Blood Center of São Paulo, Brazil in the period 2001 to 2012, 450 samples were analyzed: 372 seronegative and 78 seropositive for T. cruzi. In this evaluation, an "A" score was obtained indicating the absence of false positives and negatives. Additionally, in the same period of time the internal control values were within the accepted range of ± 2SD, with a confidence interval of 95%. The results obtained in the present study demonstrate the high quality of this

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“…According to the literature, sensitivity of the most widely used serological tests (eg, CLIA recombinant test 19 ) is virtually 100% and accordingly, some studies recommend that the T cruzi screening should be based on a single unique test when the test done is an ELISA assay. 20 However, it is generally held that the infection should be confirmed with a second serological test: this was the screening strategy in our model. We also considered a 4% presumptive falsepositive cases with the first test, for which a third screening was then required to resolve potential discrepancies between the first and the second test.…”

Section: Disease States and Transition Probabilitiesmentioning

confidence: 99%

Cost-effectiveness of Chagas disease screening in Latin American migrants at primary health-care centres in Europe: a Markov model analysis

Requena‐Méndez

Bussion

Aldasoro

et al. 2017

The Lancet Global Health

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SummaryBackground Chagas disease is currently prevalent in European countries hosting large communities from Latin America. Whether asymptomatic individuals at risk of Chagas disease living in Europe should be screened and treated accordingly is unclear. We performed an economic evaluation of systematic Chagas disease screening of the Latin American population attending primary care centres in Europe.

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WHO comparative evaluation of serologic assays for Chagas disease

Cited by 137 publications

References 13 publications

Chronic Chagas Disease Diagnosis: A Comparative Performance of Commercial Enzyme Immunoassay Tests

Chronic Chagas Disease Diagnosis: A Comparative Performance of Commercial Enzyme Immunoassay Tests

Desempeño del Kit ELISA Chagas IICS V.1 para el diagnóstico de la enfermedad de Chagas

Cost-effectiveness of Chagas disease screening in Latin American migrants at primary health-care centres in Europe: a Markov model analysis

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