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Evaluation of SAMBA II: a qualitative and semi-quantitative HIV point-of-care nucleic acid test
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4 15 2022
Source: J Acquir Immune Defic Syndr. 89(5):537-545 -
Alternative Title:J Acquir Immune Defic Syndr
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Personal Author:
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Description:Background:
Point-of-care (POC) nucleic acid tests (NAT) have potential to diagnose acute HIV infection and monitor persons taking pre-exposure prophylaxis (PrEP) or antiretroviral treatment (ART). POC NATs have not yet been evaluated in the US.
Methods:
From June 2018-March 2019, we conducted a cross-sectional evaluation of the SAMBA II POC NAT. PWH and persons testing for HIV were tested with the SAMBA II qualitative (Qual) whole blood (WB) test. From April-September 2019, the Qual test was used on persons who were ART-naïve, and SAMBA II semi-quantitative (Semi-Q) WB was used with ART-experienced PWH. Both were performed on unprocessed venipuncture (VP) and, when indicated by protocol, fingerstick (FS) WB and plasma. SAMBA results were compared to Abbott RealTime HIV-1 PCR results on plasma. We calculated sensitivity, specificity, and concordance between tests.
Results:
SAMBA was used in 330 visits among 280 participants: 202 (61.2%) visits from PWH, and 128 (38.8%) from HIV-negative persons. Qual test sensitivity with ART-naïve participants was 91.4% (32/35, 95% CI: 77.6–97.0%) using VP WB and 100% (27/27, 95% CI: 87.5–100%) using FS WB. Specificity was 100% using both specimen types. Concordance between the gold standard and Semi-Q at 1000 copies/mL among PWH on ART was 97.7% (86/88, 95% CI: 92.1–99.4%) and 100% (30/30, 95% CI: 88.7–100%) using VP and FS WB, respectively.
Conclusion:
The SAMBA II POC NATs showed high sensitivity, specificity, and concordance with the gold-standard assay, indicating its potential use in diagnostics and monitoring. Future work will evaluate POC NAT implementation in the US.
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Pubmed ID:34974473
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Pubmed Central ID:PMC9058199
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