11
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

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

      research-article

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          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.

          Related collections

          Most cited references15

          • Record: found
          • Abstract: found
          • Article: not found

          Global and regional distribution of HIV-1 genetic subtypes and recombinants in 2004.

          To estimate the global and regional distribution of HIV-1 subtypes and recombinants in 2004. A study was conducted in which molecular epidemiological data on HIV-1 subtype distribution in individual countries were combined with country-specific estimates of the number of people living with HIV. HIV-1 subtype data were collected for 23 874 HIV-1 samples from 70 countries, which together accounted for 89% of all people living with HIV worldwide in 2004. The proportions of HIV-1 infections due to various subtypes detected in each country were combined with the number of HIV infected people in the respective countries to generate regional and global HIV-1 subtype distribution estimates. Subtype C accounted for 50% of all infections worldwide in 2004. Subtypes A, B, D and G accounted for 12%, 10%, 3% and 6%, respectively. The subtypes F, H, J and K together accounted for 0.94% of infections. The circulating recombinant forms CRF01_AE and CRF02_AG each were responsible for 5% of cases, and CRF03_AB for 0.1%. Other recombinants accounted for the remaining 8% of infections. All recombinant forms taken together were responsible for 18% of infections worldwide. Combining data on HIV-1 subtype distribution in individual countries with country-specific estimates of the number of people living with HIV provided a good method to generate estimates of the global and regional HIV-1 genetic diversity in 2004. The results could serve as an important resource for HIV scientists, public health officials and HIV vaccine developers.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: found
            Is Open Access

            Scale-up of Routine Viral Load Testing in Resource-Poor Settings: Current and Future Implementation Challenges

            Cost and complexity have hindered implementation to date of viral load testing in resource-limited settings. If rapid and timely scale-up is to become a reality, numerous factors will need to be addressed, including health and laboratory system strengthening, pricing, and multiple programmatic and funding challenges.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Point-of-Care Cepheid Xpert HIV-1 Viral Load Test in Rural African Communities Is Feasible and Reliable.

              Routine monitoring of HIV-1 RNA or viral load (VL) in patients on antiretroviral therapy (ART) is important, but there are multiple impediments to VL testing in resource-constrained settings. An accurate point-of-care (POC) HIV-1 VL test could alleviate many of these challenges. We compared the performance of the Cepheid Xpert HIV-1 VL assay against the laboratory-based Abbott m2000sp/m2000rt assay (Abbott assay). ART-naive individuals participating in the Botswana Combination Prevention Project in 20 communities provided EDTA-blood specimens during household surveys. Both the POC Xpert HIV-1 VL and Abbott assays were performed on specimens sampled from 277 individuals. We found a high correlation between the Xpert HIV-1 VL and Abbott assay results (r(2) = 0.92; P 40 copies/ml) at 97.1% (95% CI, 95.5 to 98.7%), with a sensitivity of 99.6% (95% CI, 97.2 to 100%). The POC Cepheid Xpert HIV-1 VL assay showed high agreement and accuracy with a laboratory-based method of HIV-1 RNA testing. The POC Xpert HIV-1 VL assay tended to overestimate HIV-1 VL, although the difference was below a clinically relevant threshold of 0.5 log10 copies/ml. The POC Cepheid Xpert HIV-1 VL assay is a promising tool for monitoring patients on ART in southern Africa.
                Bookmark

                Author and article information

                Contributors
                Role: Editor
                Journal
                J Clin Microbiol
                J. Clin. Microbiol
                jcm
                jcm
                JCM
                Journal of Clinical Microbiology
                American Society for Microbiology (1752 N St., N.W., Washington, DC )
                0095-1137
                1098-660X
                31 January 2018
                26 March 2018
                April 2018
                26 March 2018
                : 56
                : 4
                : e01673-17
                Affiliations
                [a ]Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Canada
                [b ]McGill International TB Centre, McGill University, Montreal, Canada
                [c ]Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, Tulane, New Orleans, Louisiana, USA
                [d ]Department of Microbiology, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, India
                [e ]Manipal McGill Center for Infectious Diseases, Manipal Academy of Higher Education, Manipal, India
                [f ]Department of Medicine, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, India
                Memorial Sloan Kettering Cancer Center
                Author notes
                Address correspondence to Madhukar Pai, madhukar.pai@ 123456mcgill.ca .

                Citation Nash M, Huddart S, Badar S, Baliga S, Saravu K, Pai M. 2018. Performance of the Xpert HIV-1 viral load assay: a systematic review and meta-analysis. J Clin Microbiol 56:e01673-17. https://doi.org/10.1128/JCM.01673-17.

                Article
                01673-17
                10.1128/JCM.01673-17
                5869835
                29386266
                dcd7205b-da54-4dda-82af-7f55f0a9b73c
                Copyright © 2018 Nash et al.

                This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license.

                History
                : 19 October 2017
                : 2 November 2017
                : 26 January 2018
                Page count
                supplementary-material: 1, Figures: 3, Tables: 3, Equations: 0, References: 24, Pages: 8, Words: 4638
                Funding
                Funded by: Gouvernement du Canada | Canadian Institutes of Health Research (CIHR), https://doi.org/10.13039/501100000024;
                Award ID: CRC
                Award Recipient :
                Categories
                Virology
                Custom metadata
                April 2018

                Microbiology & Virology
                hiv,xpert hiv-1,accuracy,diagnosis,viral load
                Microbiology & Virology
                hiv, xpert hiv-1, accuracy, diagnosis, viral load

                Comments

                Comment on this article