Dataset Information

Comparison of Alere q whole blood viral load with DBS and plasma viral load in the classification of HIV virological failure.

ABSTRACT: BACKGROUND:In remote settings, timely plasma separation and transportation to testing laboratories is an impediment to the access of HIV viral load (VL) testing. Potential solutions are whole blood testing through point of care (POC) assays or dried blood spots (DBS). METHODS:We evaluated the performance of a prototype Alere q whole blood VL protocol and compared it against plasma (Abbott RealTime HIV-1) and DBS VL (Abbott RealTime HIV-1 DBS revised prototype protocol and Roche CAP/CTM HIV-1 v2.0 DBS free virus elution protocol). Virological failure (VF) was defined at >1000 copies/ml. RESULTS:Of 299 samples, Alere q correctly classified VF in 61% versus 87% by Abbott DBS and 76% by Roche FVE. Performance varied across plasma VL categories. Alere q showed 100% sensitivity. Below 1000 copies/ml of plasma, Alere q demonstrated over-quantification, with 19% specificity. Abbott DBS had 91% sensitivity and the best overall correlation with plasma (r2 = 0.72). Roche FVE had the best specificity of 99% but reduced sensitivity of 52%, especially between 1000-10,000 copies/ml of plasma. Correlation was best for all assays at >10,000 copies/ml. CONCLUSION:Variability was prominent between the assays. Each method requires optimization to facilitate the implementation of a cut-off with optimal sensitivity and specificity for VF. Although Alere q whole blood assay exhibited excellent sensitivity, the poor specificity of only 19% would lead to unnecessary switching of regimens. Thus any VF detected would need to be confirmed by a more specific assay. Both the Abbott DBS and Roche FVE protocols showed good specificity, however sensitivity was reduced when the plasma VL was 1000-10,000 copies/ml. This could result in delays in detecting VF and accumulation of drug resistance. Field evaluation in settings that have adopted these DBS protocols are necessary.

SUBMITTER: Khan A

PROVIDER: S-EPMC7259604 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Comparison of Alere q whole blood viral load with DBS and plasma viral load in the classification of HIV virological failure.

Khan Aabida A Hans Lucia L Hsiao Nei-Yuan NY

PloS one 20200529 5

<h4>Background</h4>In remote settings, timely plasma separation and transportation to testing laboratories is an impediment to the access of HIV viral load (VL) testing. Potential solutions are whole blood testing through point of care (POC) assays or dried blood spots (DBS).<h4>Methods</h4>We evaluated the performance of a prototype Alere q whole blood VL protocol and compared it against plasma (Abbott RealTime HIV-1) and DBS VL (Abbott RealTime HIV-1 DBS revised prototype protocol and Roche CA ...[more]

PMID: 32469947

Similar Datasets

Project description: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.

Dataset Information

Comparison of Alere q whole blood viral load with DBS and plasma viral load in the classification of HIV virological failure.

Publications

Comparison of Alere q whole blood viral load with DBS and plasma viral load in the classification of HIV virological failure.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets