Performance of the xpert HIV-1 viral load assay

A systematic review and meta-analysis

Madlen Nash, Sophie Huddart, Sayema Badar, Shrikala Baliga, Kavitha Saravu, Madhukar Paia

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Viral load (VL) is the preferred treatment-monitoring approach for HIV-positive patients. However, more rapid, near-patient, and low-complexity assays are needed to scale up VL testing. The Xpert HIV-1 VL assay (Cepheid, Sunnyvale, CA) is a new, automated molecular test, and it can leverage the GeneXpert systems that are being used widely for tuberculosis diagnosis. We systematically reviewed the evidence on the performance of this new tool in comparison to established reference standards. A total of 12 articles (13 studies) in which HIV patient VLs were compared between Xpert HIV VL assay and a reference standard VL assay were identified. Study quality was generally high, but substantial variability was observed in the number and type of agreement measures reported. Correlation coefficients between Xpert and reference assays were high, with a pooled Pearson correlation (n 8) of 0.94 (95% confidence interval [CI], 0.89, 0.97) and Spearman correlation (n 3) of 0.96 (95% CI, 0.86, 0.99). Bland-Altman metrics (n 11) all were within 0.35 log copies/ml of perfect agreement. Overall, Xpert HIV-1 VL performed well compared to current reference tests. The minimal training and infrastructure requirements for the Xpert HIV-1 VL assay make it attractive for use in resource-constrained settings, where point-of-care VL testing is most needed.

Original languageEnglish
Article numbere01673
JournalJournal of Clinical Microbiology
Volume56
Issue number4
DOIs
Publication statusPublished - 01-04-2018

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Viral Load
Meta-Analysis
HIV-1
HIV
Point-of-Care Systems
Confidence Intervals
Tuberculosis

All Science Journal Classification (ASJC) codes

  • Microbiology (medical)

Cite this

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abstract = "Viral load (VL) is the preferred treatment-monitoring approach for HIV-positive patients. However, more rapid, near-patient, and low-complexity assays are needed to scale up VL testing. The Xpert HIV-1 VL assay (Cepheid, Sunnyvale, CA) is a new, automated molecular test, and it can leverage the GeneXpert systems that are being used widely for tuberculosis diagnosis. We systematically reviewed the evidence on the performance of this new tool in comparison to established reference standards. A total of 12 articles (13 studies) in which HIV patient VLs were compared between Xpert HIV VL assay and a reference standard VL assay were identified. Study quality was generally high, but substantial variability was observed in the number and type of agreement measures reported. Correlation coefficients between Xpert and reference assays were high, with a pooled Pearson correlation (n 8) of 0.94 (95{\%} confidence interval [CI], 0.89, 0.97) and Spearman correlation (n 3) of 0.96 (95{\%} CI, 0.86, 0.99). Bland-Altman metrics (n 11) all were within 0.35 log copies/ml of perfect agreement. Overall, Xpert HIV-1 VL performed well compared to current reference tests. The minimal training and infrastructure requirements for the Xpert HIV-1 VL assay make it attractive for use in resource-constrained settings, where point-of-care VL testing is most needed.",
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Performance of the xpert HIV-1 viral load assay : A systematic review and meta-analysis. / Nash, Madlen; Huddart, Sophie; Badar, Sayema; Baliga, Shrikala; Saravu, Kavitha; Paia, Madhukar.

In: Journal of Clinical Microbiology, Vol. 56, No. 4, e01673, 01.04.2018.

Research output: Contribution to journalArticle

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