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Performance of the Xpert HIV-1 Viral Load Assay: a Systematic Review and Meta-analysis

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 Gene...

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Autores principales: Nash, Madlen, Huddart, Sophie, Badar, Sayema, Baliga, Shrikala, Saravu, Kavitha, Pai, Madhukar
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Society for Microbiology 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5869835/
https://www.ncbi.nlm.nih.gov/pubmed/29386266
http://dx.doi.org/10.1128/JCM.01673-17
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author Nash, Madlen
Huddart, Sophie
Badar, Sayema
Baliga, Shrikala
Saravu, Kavitha
Pai, Madhukar
author_facet Nash, Madlen
Huddart, Sophie
Badar, Sayema
Baliga, Shrikala
Saravu, Kavitha
Pai, Madhukar
author_sort Nash, Madlen
collection PubMed
description 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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spelling pubmed-58698352018-04-06 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 Pai, Madhukar J Clin Microbiol Virology 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. American Society for Microbiology 2018-03-26 /pmc/articles/PMC5869835/ /pubmed/29386266 http://dx.doi.org/10.1128/JCM.01673-17 Text en Copyright © 2018 Nash et al. https://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Virology
Nash, Madlen
Huddart, Sophie
Badar, Sayema
Baliga, Shrikala
Saravu, Kavitha
Pai, Madhukar
Performance of the Xpert HIV-1 Viral Load Assay: a Systematic Review and Meta-analysis
title Performance of the Xpert HIV-1 Viral Load Assay: a Systematic Review and Meta-analysis
title_full Performance of the Xpert HIV-1 Viral Load Assay: a Systematic Review and Meta-analysis
title_fullStr Performance of the Xpert HIV-1 Viral Load Assay: a Systematic Review and Meta-analysis
title_full_unstemmed Performance of the Xpert HIV-1 Viral Load Assay: a Systematic Review and Meta-analysis
title_short Performance of the Xpert HIV-1 Viral Load Assay: a Systematic Review and Meta-analysis
title_sort performance of the xpert hiv-1 viral load assay: a systematic review and meta-analysis
topic Virology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5869835/
https://www.ncbi.nlm.nih.gov/pubmed/29386266
http://dx.doi.org/10.1128/JCM.01673-17
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