Performance evaluation of the point-of-care SAMBA I and II HIV-1 Qual whole blood tests.
J Virol Methods
; 237: 143-149, 2016 11.
Article
em En
| MEDLINE
| ID: mdl-27568275
ABSTRACT
The SAMBA HIV-1 Qual Whole Blood Test is a nucleic acid-based amplification assay for the qualitative detection of HIV-1 in whole blood of adults or infants. The test can be run on either the semi-automated SAMBA I system for clinical use or the fully automated, including readout, SAMBA II system for point-of-care use in resource-limited settings. We have assessed the performance characteristics of the SAMBA HIV-1 Qual Whole Blood Test on SAMBA I and SAMBA II. The limit of detection obtained for the two tests were 518IU/ml and 399copies/ml on SAMBA I and 457IU/ml and 433copies/ml on SAMBA II. Test specificity on both systems was 100% with a panel of 503 HIV-1 negative samples. Evaluation of test reproducibility showed 100% concordance with expected gold standard results as well as 100% agreement between operators, days, and runs as well as within runs on both SAMBA I and SAMBA II. Our results thus show that the SAMBA HIV-1 Qual Whole Blood Test performs equivalently on SAMBA I and SAMBA II, and also suggest that the test is suitable for implementation in medium-throughput clinical facilities (SAMBA I) or low-throughput point-of-care (POC) settings (SAMBA II) in resource-poor regions.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Infecções por HIV
/
HIV-1
/
Sistemas Automatizados de Assistência Junto ao Leito
/
Técnicas de Amplificação de Ácido Nucleico
Tipo de estudo:
Diagnostic_studies
/
Evaluation_studies
/
Qualitative_research
/
Screening_studies
Limite:
Adult
/
Humans
/
Infant
Idioma:
En
Ano de publicação:
2016
Tipo de documento:
Article