Systematic review of the performance of HIV viral load technologies on plasma samples.
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 articleSubject
AlgorithmsDeveloping 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
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https://hdl.handle.net/10161/14703Published Version (Please cite this version)
10.1371/journal.pone.0085869Publication 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.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
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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