The application of latent class analysis for diagnostic test validation of chronic Trypanosoma cruzi infection in blood donors

Langhi, Dante Mário; Bordin, José Orlando; Castelo, Adauto; Walter, Stephen D.; Moraes-Souza, Hélio; Stumpf, Robert J.

doi:10.1590/s1413-86702002000400005

Cited by 22 publications

(5 citation statements)

References 11 publications

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“…However, when the index test is applied in clinical settings, there will be no such gold standard to monitor the veracity of a test. In other studies [16], [22], initially positive or indeterminate samples were evaluated in duplicate and considered positive only when a repeated test was positive. Therefore, it is important to acknowledge that the reported accuracy in many studies is not that of the index test alone, but rather the accuracy of the entire testing strategy that was implemented.…”

Section: Discussionmentioning

confidence: 99%

A Systematic Review of High Quality Diagnostic Tests for Chagas Disease

2012

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BackgroundThere is significant heterogeneity in reported sensitivities and specificities of diagnostic serological assays for Chagas disease, as might be expected from studies that vary widely according to setting, research design, antigens employed, and reference standard. The purpose of this study is to summarize the reported accuracy of serological assays and to identify sources of heterogeneity including quality of research design. To avoid associated spectrum bias, our analysis was limited to cohort studies.MethodsWe completed a search of PubMed, a bibliographic review of potentially relevant articles, and a review of articles identified by a study author involved in this area of research. Studies were limited to prospective cohort studies of adults published since 1985. Measures of diagnostic accuracy were pooled using a Der Simonian Laird Random Effects Model. A subgroup analysis and meta regression were employed to identify sources of heterogeneity. The QUADAS tool was used to assess quality of included studies and Begg's funnel plot was used to assess publication bias.ResultsEighteen studies and 61 assays were included in the final analysis. Significant heterogeneity was found in all pre-determined subgroups. Overall sensitivity was 90% (95% CI: 89%–91%) and overall specificity was 98% (95% CI: 98%–98%).ConclusionSensitivity and specificity of serological assays for the diagnosis of Chagas disease appear less accurate than previously thought. Suggestions to improve the accuracy of reporting include the enrollment of patients in a prospective manner, double blinding, and providing an explicit method of addressing subjects that have an indeterminate diagnosis by either the reference standard or index test.

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Section: Discussionmentioning

confidence: 99%

A Systematic Review of High Quality Diagnostic Tests for Chagas Disease

2012

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“…Several studies have used LCA for the evaluation of diagnostic tests, such as Langhi Junior et al. (2002) and Andrade and Gontijo (2008) for Chagas’ disease, Girardi et al.…”

Section: Introductionmentioning

confidence: 99%

Latent class analysis of diagnostic tests for visceral leishmaniasis in Brazil

Assis

Rabello

Werneck

2012

Tropical Med Int Health

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Abstractobjective To estimate the sensitivities and specificities of different diagnostic tests for visceral leishmaniasis (VL) using latent class analysis (LCA). conclusions Considering the lack of an adequate reference standard, LCA proved to be a useful tool in validating diagnostic methods for VL. The DAT and the rK39 rapid test showed better performance. Thus, clinically suspected cases of VL in a Brazilian endemic area could be treated based on the positivity of one of these tests.

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“…Individually, the TESA-blot test performed the closest to the gold standard with the lowest FPRs and FNRs and could be used to confirm inconclusive results at blood banks, as already mentioned in the literature 10 , 12 . Unfortunately, it is not currently available.…”

Section: Discussionmentioning

confidence: 67%

“…In addition, IgG subclass analysis using immunofluorescence showed that the levels of immunoglobulin production were IgG1 > IgG3 > IgG2 > IgG4 in patients with chronic Chagas disease with cardiopathy 12 , which justifies the development of serological tests with different subclasses of IgG in ELISA.…”

Section: Introductionmentioning

confidence: 99%

“…These data confirm the persistence of inconclusive results, which, in this study, occurred in both new and returning donors, including those with up to 29 repeatedly non-reactive donations. The search for confirmatory tests, such as the trypomastigote excreted-secreted antigen (TESA)-blot 7 , 8 , 9 , radioimmunoprecipitation assay 10 , 11 and/or application of latent class analysis 12 , that can be routinely used in blood banks to define the exact profile of blood donors with 100% certainty has been the subject of several studies.…”

Section: Introductionmentioning

confidence: 99%

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Chagas disease: Performance analysis of immunodiagnostic tests anti-Trypanosoma cruzi in blood donors with inconclusive screening results

Ferreira-Silva

Pereira

Rodrigues-Júnior

et al. 2021

Hematology, Transfusion and Cell Therapy

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Background The screening of Trypanosoma cruzi -infected blood donors using two serological techniques frequently leads to conflicting results. This fact prompted us to evaluate the diagnostic performance of four “in-house” immunodiagnostic tests and two commercially available enzyme-linked immunosorbent assays (ELISAs). Material and Methods One hundred and seventy-nine blood donors, whose screening for Chagas disease was doubtful, underwent three in-house ELISAs, one in-house immunoblotting test (TESA-blot), and two commercial ELISAs (bioMérieux and Wiener) in an attempt to define the presence or absence of infection. Simultaneously, 29 donors with previous positive results from three conventional serological tests and 30 donors with constant negative results were evaluated. Results The ELISA-Wiener showed the highest rate in sensitivity (98.92%) and the ELISA-bioMérieux, the highest specificity (99.45%), followed by the TESA-blot, which showed superior performance, with lower false-negative (2.18%) and false-positive (1.12%) rates. In series, the combination composed of the TESA-blot and ELISA-bioMérieux showed slightly superior performance, with trifunctional protein deficiency (TFP) = 0.01%. Conclusion Our study confirms the high sensitivity and specificity of commercial kits. To confirm the presence or absence of T. cruzi infection, the combination of TESA-blot and ELISA-bioMérieux may be suggested as the best alternative. Individually, the TESA-blot performed the closest to the gold standard; however, it is not commercially available.

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The application of latent class analysis for diagnostic test validation of chronic Trypanosoma cruzi infection in blood donors

Cited by 22 publications

References 11 publications

A Systematic Review of High Quality Diagnostic Tests for Chagas Disease

A Systematic Review of High Quality Diagnostic Tests for Chagas Disease

Latent class analysis of diagnostic tests for visceral leishmaniasis in Brazil

Chagas disease: Performance analysis of immunodiagnostic tests anti-Trypanosoma cruzi in blood donors with inconclusive screening results

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