| Literature DB >> 27568275 |
Allyson V Ritchie1, Neha Goel1, Hiroshi Sembongi2, Jesse Lehga3, Laura E Farleigh2, Daniel Edemaga3, Craig A Wisniewski4, Helen H Lee5.
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.Entities:
Keywords: Diagnosis; Early infant diagnosis; HIV-1; Point-of-care
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Year: 2016 PMID： 27568275 DOI： 10.1016/j.jviromet.2016.08.017
Source DB: PubMed Journal: J Virol Methods ISSN： 0166-0934 Impact factor: 2.014