TY - JOUR
T1 - Performance of the xpert HIV-1 viral load assay
T2 - A systematic review and meta-analysis
AU - Nash, Madlen
AU - Huddart, Sophie
AU - Badar, Sayema
AU - Baliga, Shrikala
AU - Saravu, Kavitha
AU - Paia, Madhukar
N1 - Funding Information:
This study was supported by a TMA Pai Endowment Chair to M.P. at Manipal University, India, and the Manipal McGill Centre for Infectious Diseases (MAC ID). M.P. is also supported by a Canada Research Chair award. S.H. has a fellowship from the FRQS.
Publisher Copyright:
Copyright © 2018 Nash et al.
PY - 2018/4/1
Y1 - 2018/4/1
N2 - 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.
AB - 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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U2 - 10.1128/JCM.01673-17
DO - 10.1128/JCM.01673-17
M3 - Article
AN - SCOPUS:85044713163
SN - 0095-1137
VL - 56
JO - Journal of Clinical Microbiology
JF - Journal of Clinical Microbiology
IS - 4
M1 - e01673
ER -
