Application of WHO International Biological Reference Standards to evaluate commercial serological tests for chronic Chagas disease



Document title: Application of WHO International Biological Reference Standards to evaluate commercial serological tests for chronic Chagas disease
Journal: Memorias do Instituto Oswaldo Cruz
Database: PERIÓDICA
System number: 000437100
ISSN: 0074-0276
Authors: 1
2
3
1
1
3
2
2
4
Institutions: 1Sociedade Brasileira de Analises Clinicas, Programa Nacional de Controle de Qualidade, Rio de Janeiro. Brasil
2Fundacao Oswaldo Cruz, Instituto Oswaldo Cruz, Rio de Janeiro. Brasil
3Fundacao Oswaldo Cruz, Centro de Desenvolvimento Tecnologico em Saude, Rio de Janeiro. Brasil
4World Health Organization, Department of Control of Neglected Tropical Diseases, Ginebra. Suiza
Year:
Volumen: 115
Country: Brasil
Language: Inglés
Document type: Artículo
Approach: Analítico, descriptivo
English abstract Chagas disease, resulting from Trypanosoma cruzi infections, continues to be a health concern mainly in Latin American countries where the parasite is endemic. The laboratory diagnosis of a chronic infection is determined through serological assays for antibodies against T. cruzi and several tests are available that differ in key components, formats and methodologies. To date, no single test meets the criteria of a gold standard. The situation is further complicated by the difficulties associated with performance comparisons between different immunoassays or methodologies executed at different times and geographical areas. OBJECTIVE To improve the diagnosis of Chagas disease, the WHO coordinated the development of two International Biological Reference Standards for antibodies against anti-T. cruzi: NIBSC 09/186 and NIBSC 09/188 that respectively represent geographical regions with the highest prevalence of TcII and TcI lineages of the parasite. METHODS The principle goal of this study was to verify the behavior of these standards when assayed by several commercially available serological tests that employ different methods to capture and detect human anti-T. cruzi antibodies. FINDINGS AND MAIN CONCLUSIONS The results reinforce the recommendation that these standards be considered for performance evaluations of commercialised immunoassays and should be an integral step in the development of new test components or assay paradigms
Disciplines: Medicina
Keyword: Diagnóstico,
Parasitología,
Enfermedad de Chagas,
Pruebas diagnósticas,
Pruebas serológicas,
Inmunoensayo,
Trypanosoma cruzi
Keyword: Diagnosis,
Parasitology,
Chagas disease,
Trypanosoma cruzi,
Diagnostic tests,
Serological tests,
Immunoassay
Full text: Texto completo (Ver HTML) Texto completo (Ver PDF)