Comparative evaluation of immunoassays to improve access to diagnosis for Chagas disease in Colombia
| Autor: | Carlos A. Valencia-Hernández, Ricardo Andrés Caicedo Díaz, Oscar Bernal, Mauricio Javier Vera, Colin Forsyth, Eduin Pachón Abril, Mauricio Beltrán Duran, Andrea Marchiol, Astrid Carolina Flórez Sánchez, Carolina Batista, Rafael Herazo |
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| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Microbiology (medical) Chagas disease medicine.medical_specialty Trypanosoma cruzi 030106 microbiology Antibodies Protozoan Colombia Reference laboratory Sensitivity and Specificity lcsh:Infectious and parasitic diseases Standard procedure Comparative evaluation 03 medical and health sciences 0302 clinical medicine Internal medicine parasitic diseases medicine Humans lcsh:RC109-216 Chagas Disease 030212 general & internal medicine Immunoassay biology Capture elisa business.industry General Medicine medicine.disease biology.organism_classification Six million Infectious Diseases business |
| Zdroj: | International Journal of Infectious Diseases, Vol 87, Iss, Pp 100-108 (2019) |
| ISSN: | 1201-9712 |
| Popis: | Objective: Chagas disease affects over six million people, but less than 1% are diagnosed and treated. Complicated diagnostic processes are a major barrier. Colombia’s previous diagnostic algorithm, using in-house tests, was difficult to scale up, creating significant access barriers for patients. A new algorithm using commercially manufactured immunoassays would potentially improve access, but these tests’ performance in Colombian patients with Chagas disease is not well known. Methods: We assessed seven commercially available assays. Samples (n = 501), 93.8% originating from Colombia, were characterized as positive or negative based on standard procedure at the National Reference Laboratory. Performance characteristics were calculated for individual assays and hypothetical test pairings, then compared to the existing algorithm. Results: Five of seven assays exhibited sensitivity >98% while six showed specificity >97%. A total antigen ELISA paired with a recombinant assay provided similar performance to the current diagnostic process. Six of six assays tested proved capable of detecting different Trypanosoma cruzi genetic lineages. Conclusions: The study indicated that several commercial assays accurately detect T. cruzi infection in Colombian patients. A simplified testing process with two commercial assays could perform comparably to the previous process, reducing cost and accessibility barriers and facilitating national scale-up. Keywords: Trypanosoma cruzi, Chagas disease, Enzyme-linked immunosorbent assays, Diagnostic barriers, Access to healthcare, Neglected tropical diseases (NTDs) |
| Databáze: | OpenAIRE |
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