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Systematic review of the performance of HIV viral load technologies on plasma samples.

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Date
2014
Authors
Sollis, Kimberly A
Smit, Pieter W
Fiscus, Susan
Ford, Nathan
Vitoria, Marco
Essajee, Shaffiq
Barnett, David
Cheng, Ben
Crowe, Suzanne M
Denny, Thomas
Landay, Alan
Stevens, Wendy
Habiyambere, Vincent
Perrins, Jos
Peeling, Rosanna W
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Abstract
BACKGROUND: Viral load (VL) monitoring is the standard of care in developing country settings for detecting HIV treatment failure. Since 2010 the World Health Organization has recommended a phase-in approach to VL monitoring in resource-limited settings. We conducted a systematic review of the accuracy and precision of HIV VL technologies for treatment monitoring. METHODS AND FINDINGS: A search of Medline and Embase was conducted for studies evaluating the accuracy or reproducibility of commercially available HIV VL assays. 37 studies were included for review including evaluations of the Amplicor Monitor HIV-1 v1.5 (n = 25), Cobas TaqMan v2.0 (n = 11), Abbott RealTime HIV-1 (n = 23), Versant HIV-1 RNA bDNA 3.0 (n = 15), Versant HIV-1 RNA kPCR 1.0 (n = 2), ExaVir Load v3 (n = 2), and NucliSens EasyQ v2.0 (n = 1). All currently available HIV VL assays are of sufficient sensitivity to detect plasma virus levels at a lower detection limit of 1,000 copies/mL. Bias data comparing the Abbott RealTime HIV-1, TaqMan v2.0 to the Amplicor Monitor v1.5 showed a tendency of the Abbott RealTime HIV-1 to under-estimate results while the TaqMan v2.0 overestimated VL counts. Compared to the Amplicor Monitor v1.5, 2-26% and 9-70% of results from the Versant bDNA 3.0 and Abbott RealTime HIV-1 differed by greater than 0.5log10. The average intra and inter-assay variation of the Abbott RealTime HIV-1 were 2.95% (range 2.0-5.1%) and 5.44% (range 1.17-30.00%) across the range of VL counts (2log10-7log10). CONCLUSIONS: This review found that all currently available HIV VL assays are of sufficient sensitivity to detect plasma VL of 1,000 copies/mL as a threshold to initiate investigations of treatment adherence or possible treatment failure. Sources of variability between VL assays include differences in technology platform, plasma input volume, and ability to detect HIV-1 subtypes. Monitoring of individual patients should be performed on the same technology platform to ensure appropriate interpretation of changes in VL. Prospero registration # CD42013003603.
Type
Journal article
Subject
Algorithms
Developing Countries
HIV Infections
HIV Seropositivity
HIV-1
Humans
Molecular Diagnostic Techniques
Plasma
Polymerase Chain Reaction
Reagent Kits, Diagnostic
Reproducibility of Results
Sensitivity and Specificity
Serologic Tests
Viral Load
World Health Organization
Permalink
https://hdl.handle.net/10161/14703
Published Version (Please cite this version)
10.1371/journal.pone.0085869
Publication Info
Sollis, Kimberly A; Smit, Pieter W; Fiscus, Susan; Ford, Nathan; Vitoria, Marco; Essajee, Shaffiq; ... Peeling, Rosanna W (2014). Systematic review of the performance of HIV viral load technologies on plasma samples. PLoS One, 9(2). pp. e85869. 10.1371/journal.pone.0085869. Retrieved from https://hdl.handle.net/10161/14703.
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Scholars@Duke

Denny

Thomas Norton Denny

Professor in Medicine
Thomas N. Denny, MSc, M.Phil, is the Chief Operating Officer of the Duke Human Vaccine Institute (DHVI) and the Center for HIV/AIDS Vaccine Immunology (CHAVI), and a Professor of Medicine in the Department of Medicine at Duke University Medical Center. He is also an Affiliate Member of the Duke Global Health Institute. He has recently been appointed to the Duke University Fuqua School of Business Health Sector Advisory Council. Previously, he was an Associate Professor of Pathology, Laboratory M
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