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Chronic Chagas Disease Diagnosis: A Comparative Performance of Commercial Enzyme Immunoassay Tests
Fred Luciano Neves Santos1, Wayner Vieira de Souza2, Michelle da Silva Barros2
1Reference Laboratory for Chagas Disease, Aggeu Magalhães Research Center, Fundação Oswaldo Cruz, Recife, Brazil; Department of Public Health, Aggeu Magalhães Research Center, Fundação Oswaldo Cruz, Recife, Brazil; Carlos Chagas Institute-Molecular Biology Institute of Paraná, Fundação Oswaldo Cruz, Curitiba, Brazil fred.santos@cpqam.fiocruz.br.
Insights
This study evaluated four enzyme-linked immunosorbent assay tests for Chagas disease diagnosis. While all showed good sensitivity, specificity and cross-reactivity varied, especially with leishmaniasis, requiring careful interpretation in endemic areas.
Area of Science:
- Infectious Diseases
- Immunology
- Parasitology
Background:
- Conventional serological assays for Chagas disease exhibit significant heterogeneity and performance issues, leading to inconclusive and misclassified results.
- The diagnosis of Chagas disease relies heavily on serological testing, highlighting the need for accurate and reliable diagnostic tools in both clinical and blood bank settings.
Purpose of the Study:
- To assess the diagnostic quality of four commercially available enzyme-linked immunosorbent assay (ELISA) tests for detecting Trypanosoma cruzi antibodies.
- To evaluate the specificity and cross-reactivity of these ELISA tests using sera from patients with Chagas disease and other unrelated diseases.
Main Methods:
- Analyzed 685 sera samples from patients for Trypanosoma cruzi antibodies using four different ELISA kits.
- Assessed cross-reactivity by testing 748 sera from patients with unrelated diseases, including leishmaniasis.
- Compared the performance of ELISA tests utilizing whole Trypanosoma cruzi extracts versus recombinant proteins.
Main Results:
- All four ELISA tests demonstrated good discriminatory ability and similar sensitivity in detecting Trypanosoma cruzi infection in chronic Chagas disease patients.
- Significant variations in specificity and cross-reactivity were observed among the evaluated tests.
- Higher cross-reactivity levels were noted in tests using whole T. cruzi extracts compared to those using recombinant proteins, particularly with sera from leishmaniasis patients.
Conclusions:
- The evaluated ELISA tests are suitable for laboratory diagnosis and blood screening for Chagas disease, exhibiting generally good performance.
- Caution is advised when interpreting results from these tests in regions where endemic diseases like leishmaniasis are prevalent due to potential cross-reactivity.
- The choice of antigen (whole extract vs. recombinant protein) impacts test specificity and cross-reactivity, suggesting a preference for recombinant antigens in certain contexts.
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 enzyme-linked immunosorbent assay tests for their ability to detect Trypanosoma cruzi antibodies in 685 sera samples. Cross-reactivity 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.
