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

Sollis KA, Smit PW, Fiscus S, Ford N, Vitoria M, Essajee S, Barnett D, Cheng B, Crowe SM, Denny T, Landay A, Stevens W, Habiyambere V, Perrins J, Peeling RW - PLoS ONE (2014)

Bottom Line: 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.Prospero registration # CD42013003603.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, United Kingdom.

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.

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Related in: MedlinePlus

Bias between Index Test and Ampicor v1.5 as a comparator (data extracted from references [19], [24], [25], [29], [37], [38], [40], [41], [43], [45], [46], [48], [52], [55]). *No volume specified.
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pone-0085869-g003: Bias between Index Test and Ampicor v1.5 as a comparator (data extracted from references [19], [24], [25], [29], [37], [38], [40], [41], [43], [45], [46], [48], [52], [55]). *No volume specified.

Mentions: Bias was measured between an index test and the Amplicor v1.5 as a reference standard in 14 publications [19], [24], [25], [29], [37], [38], [40], [41], [43], [45], [46], [48], [52], [55]. These included comparisons with the Abbott RealTime (n = 11) [19], [25], [29], [38], [40], [45], [46], [48], [55], TaqMan v2.0 (n = 4) [24], [25], [41], and bDNA 3.0 (n = 4) [37], [43], [52]. There were no bias data available comparing the ExaVir v3, EasyQ v2.0, or the kPCR to the Monitor v1.5. Figure 3 summarizes the range of bias measurements reported and the variability in the limits of agreement reported for each assay when evaluated alongside the Amplicor v1.5.


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

Sollis KA, Smit PW, Fiscus S, Ford N, Vitoria M, Essajee S, Barnett D, Cheng B, Crowe SM, Denny T, Landay A, Stevens W, Habiyambere V, Perrins J, Peeling RW - PLoS ONE (2014)

Bias between Index Test and Ampicor v1.5 as a comparator (data extracted from references [19], [24], [25], [29], [37], [38], [40], [41], [43], [45], [46], [48], [52], [55]). *No volume specified.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3928047&req=5

pone-0085869-g003: Bias between Index Test and Ampicor v1.5 as a comparator (data extracted from references [19], [24], [25], [29], [37], [38], [40], [41], [43], [45], [46], [48], [52], [55]). *No volume specified.
Mentions: Bias was measured between an index test and the Amplicor v1.5 as a reference standard in 14 publications [19], [24], [25], [29], [37], [38], [40], [41], [43], [45], [46], [48], [52], [55]. These included comparisons with the Abbott RealTime (n = 11) [19], [25], [29], [38], [40], [45], [46], [48], [55], TaqMan v2.0 (n = 4) [24], [25], [41], and bDNA 3.0 (n = 4) [37], [43], [52]. There were no bias data available comparing the ExaVir v3, EasyQ v2.0, or the kPCR to the Monitor v1.5. Figure 3 summarizes the range of bias measurements reported and the variability in the limits of agreement reported for each assay when evaluated alongside the Amplicor v1.5.

Bottom Line: 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.Prospero registration # CD42013003603.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, United Kingdom.

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.

Show MeSH
Related in: MedlinePlus