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Performance evaluation of the point-of-care SAMBA I and II HIV-1 Qual whole blood tests.

Performance evaluation of the point-of-care SAMBA I and II HIV-1 Qual whole blood tests.
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Ritchie AV, Goel N, Sembongi H, Lehga J, Farleigh LE, Edemaga D, Wisniewski CA, Lee HH,


Ritchie AV, Goel N, Sembongi H, Lehga J, Farleigh LE, Edemaga D, Wisniewski CA, Lee HH, (click to view)

Ritchie AV, Goel N, Sembongi H, Lehga J, Farleigh LE, Edemaga D, Wisniewski CA, Lee HH,

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Journal of virological methods 2016 8 24() pii 10.1016/j.jviromet.2016.08.017

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 518 IU/ml and 399 copies/ml on SAMBA I and 457 IU/ml and 433 copies/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.

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