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

ABSTRACT: 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.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).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.

SUBMITTER: Sollis KA

PROVIDER: S-EPMC3928047 | biostudies-other | 2014

REPOSITORIES: biostudies-other

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

Sollis Kimberly A KA Smit Pieter W PW Fiscus Susan S Ford Nathan N Vitoria Marco M Essajee Shaffiq S Barnett David D Cheng Ben B Crowe Suzanne M SM Denny Thomas T Landay Alan A Stevens Wendy W Habiyambere Vincent V Perrins Jos J Peeling Rosanna W RW

PloS one 20140218 2

<h4>Background</h4>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.<h4>Methods and findings</h4>A search of Medline and Embase was conducted for studies evaluating the accuracy or reproducibilit ...[more]

PMID: 24558359

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Project description:IntroductionGuidelines for antiretroviral therapy recommend enhanced adherence counselling be provided to individuals with an initial elevated viral load before making a decision whether to switch antiretroviral regimen. We undertook this systematic review to estimate the proportion of patients with an initial elevated viral load who resuppress following enhanced adherence counselling.MethodsTwo databases and two conference abstract sites were searched from January 2012 to October 2019 for studies reporting the number of patients with an elevated viral load whose viral load was undetectable when subsequently assessed. Data were pooled using random effects meta-analysis.ResultsFifty-eight studies reported outcomes of 45,720 viraemic patients, mostly from Africa (48 studies), and among patients on first-line antiretroviral therapy (43 studies). Almost half (46.1%, 95% CI 42.6% to 49.5%) of patients with an initial elevated viral load resuppressed following an enhanced adherence intervention. Of those on first-line ART with confirmed virological failure (6280 patients, 21 studies), only 53.4% (40.1% to 66.8%) were appropriately switched to a different regimen. Resuppression was higher among studies that provided details of adherence support. The proportion resuppressing was lower among children (31.2%, 21.1% to 41.3%) and adolescents (40.4%, 15.7% to 65.2%) compared to adults (50.4%, 42.6% to 58.3%). No important differences were observed by date of study publication, gender, viral failure threshold, publication status, time between viral loads or treatment regimen. Information on resistance testing among people with an elevated viral load was inconsistently reported.ConclusionsThe findings of this review suggest that in settings with limited resources, current guideline recommendations to provide enhanced adherence counselling can result in resuppression of a substantial number of these patients, avoiding unnecessary drug regimen changes. Appropriate action on viral load results is limited across a range of settings, highlighting the importance of viral load cascade analyses to identify gaps and focus quality improvement to ensure that action is taken on the results of viral load testing.

Project description:Dried blood spot (DBS) may overestimate the viral RNA, mainly in patients with low viral load (VL), due to proviral DNA and intracellular RNA. The Burnett and HemaSpot provide integrated solutions for the collection, separation, and drying of plasma from whole blood. This study aims to evaluate the performance of both devices compared to plasma to identify antiretroviral therapy (ART) failure. The devices were separately evaluated in a cross-sectional design. Patients on ART were included for the studies (Burnett: 611, October 2019 to January 2020) and (HemaSpot: 620, November 2020 to April 2021). VL was tested using CAP/CTM96. The sensitivity and specificity of DBS, Burnett, and HemaSpot were determined, and plasma results were considered as a reference at a threshold of 1,000 copies/ml. For the Burnett study, 2,444 specimens, including plasma, DBS, venous Burnett (vBurnett), and capillary Burnett (cBurnett), were collected. Sensitivity of DBS, vBurnett, and cBurnett was 97.4%, 98.3%, and 97.5%, respectively, whereas specificity was 86.8% for DBS, 96.9% for vBurnett, and 93.9% for cBurnett. For the HemaSpot study, 1,860 specimens were collected, including plasma, DBS, and vHemaSpot. Sensitivity of DBS and vHemaSpot was 95.0% and 91.3%, respectively, whereas specificity was 86.9% for DBS and 94.5% for vHemaSpot. The misclassification rate was more prominent in DBS (4.8%) and HemaSpot (8.4%) but lower in vBurnett (2.0%) and cBurnett (3.2%). The Burnett showed better performance than DBS, whereas HemaSpot showed poorer performance than DBS. Nevertheless, both Burnett and HemaSpot have high rate of non-reportable results. In the current format, neither of the two devices is feasible for VL scale-up in resource-limited settings.IMPORTANCEBurnett and HemaSpot are two novel technologies that allow whole blood collection and plasma separation and stabilization at room temperature without the need of additional equipment. Hence, these devices are potential alternatives to fresh plasma as a suitable specimen for viral load scale-up to monitor antiretroviral therapy in resource-limited settings.

Project description:BackgroundAccurate routine HIV viral load testing is essential for assessing the efficacy of antiretroviral treatment (ART) regimens and the emergence of drug resistance. While the use of plasma specimens is the standard for viral load testing, its use is restricted by the limited ambient temperature stability of viral load biomarkers in whole blood and plasma during storage and transportation and the limited cold chain available between many health care facilities in resource-limited settings. Alternative specimen types and technologies, such as dried blood spots, may address these issues and increase access to viral load testing; however, their technical performance is unclear. To address this, we conducted a meta-analysis comparing viral load results from paired dried blood spot and plasma specimens analyzed with commonly used viral load testing technologies.Methods and findingsStandard databases, conferences, and gray literature were searched in 2013 and 2018. Nearly all studies identified (60) were conducted between 2007 and 2018. Data from 40 of the 60 studies were included in the meta-analysis, which accounted for a total of 10,871 paired dried blood spot:plasma data points. We used random effects models to determine the bias, accuracy, precision, and misclassification for each viral load technology and to account for between-study variation. Dried blood spot specimens produced consistently higher mean viral loads across all technologies when compared to plasma specimens. However, when used to identify treatment failure, each technology compared best to plasma at a threshold of 1,000 copies/ml, the present World Health Organization recommended treatment failure threshold. Some heterogeneity existed between technologies; however, 5 technologies had a sensitivity greater than 95%. Furthermore, 5 technologies had a specificity greater than 85% yet 2 technologies had a specificity less than 60% using a treatment failure threshold of 1,000 copies/ml. The study's main limitation was the direct applicability of findings as nearly all studies to date used dried blood spot samples prepared in laboratories using precision pipetting that resulted in consistent input volumes.ConclusionsThis analysis provides evidence to support the implementation and scale-up of dried blood spot specimens for viral load testing using the same 1,000 copies/ml treatment failure threshold as used with plasma specimens. This may support improved access to viral load testing in resource-limited settings lacking the required infrastructure and cold chain storage for testing with plasma specimens.

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

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

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