Application of WHO International Biological Reference Standards to evaluate commercial serological tests for chronic Chagas disease.
Mem Inst Oswaldo Cruz
; 115: e200214, 2020.
Article
em En
| MEDLINE
| ID: mdl-32725060
ABSTRACT
BACKGROUND 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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Trypanosoma cruzi
/
Testes Sorológicos
/
Doença de Chagas
Tipo de estudo:
Diagnostic_studies
/
Guideline
/
Risk_factors_studies
Limite:
Humans
Idioma:
En
Revista:
Mem Inst Oswaldo Cruz
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Brasil