ArticlePloS one2016
Options to Expand HIV Viral Load Testing in South Africa: Evaluation of the GeneXpert® HIV-1 Viral Load Assay.
Article in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 4 of them syntheses that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
30 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Point-of-care viral load tests to detect high HIV viral load in people living with HIV/AIDS attending health facilities.The Cochrane database of systematic reviews · 2022Pooled it
- Performance of Cepheid Xpert HIV-1 viral load plasma assay to accurately detect treatment failure.AIDS (London, England) · 2019Pooled it
- Systematic review of the performance and clinical utility of point of care HIV-1 RNA testing for diagnosis and care.PloS one · 2019Pooled it
- Performance of the Xpert HIV-1 Viral Load Assay: a Systematic Review and Meta-analysis.Journal of clinical microbiology · 2018Pooled it
- Timeliness of Point-of-Care Viral Load Results Improves Human Immunodeficiency Virus Monitoring in Nigeria.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Trial
- Trial
- Evaluating the accuracy of HIV-1 viral load testing using near point of care Xpert HIV-1 system at Solwezi general hospital, Zambia.BMC research notes · 2025Article
- Rapid diagnosis of acute HIV-1 infection cases: first real-world performance of point-of-care HIV-1 nucleic acid testing in China.Frontiers in public health · 2025Article
- Assessment of the performance of the plasma separation card for HIV-1 viral load monitoring in South Africa.Journal of clinical microbiology · 2024Article
- Quality Assurance for Hepatitis C Virus Point-of-Care Diagnostics in Sub-Saharan Africa.Diagnostics (Basel, Switzerland) · 2023Review
- An Ultracompact Real-Time Fluorescence Loop-Mediated Isothermal Amplification (LAMP) Analyzer.Methods in molecular biology (Clifton, N.J.) · 2022Article
- The Development of a Standardized Quality Assessment Material to Support XpertDiagnostics (Basel, Switzerland) · 2021Article
- Performance of the Roche cobas MTB Assay for the Molecular Diagnosis of Pulmonary Tuberculosis in a High HIV Burden Setting.The Journal of molecular diagnostics : JMD · 2020Article
- SNAPflex: a paper-and-plastic device for instrument-free RNA and DNA extraction from whole blood.Lab on a chip · 2020Article
- Article
- Evaluation of the performance of the Cepheid Xpert HIV-1 Viral Load Assay for quantitative and diagnostic uses.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2020Article
- Determining virological suppression and resuppression by point-of-care viral load testing in a HIV care setting in sub-Saharan Africa.EClinicalMedicine · 2020Article
- Performance Comparison of Xpert HIV-1 Viral Load Assay and Roche Taqman and Abbott M2000 RT in Bamako, Mali.Journal of AIDS & clinical research · 2020Article
- Point-of-Care HIV Viral Load Testing: an Essential Tool for a Sustainable Global HIV/AIDS Response.Clinical microbiology reviews · 2019Review
- The role of point-of-care viral load monitoring in achieving the target of 90% suppression in HIV-infected patients in Nigeria: study protocol for a randomized controlled trial.BMC infectious diseases · 2019Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundExpansion of HIV viral load (VL) testing services are required to meet increased targets for monitoring patients on antiretroviral treatment. South Africa currently tests >4million VLs per annum in 16 highly centralised, automated high-throughput laboratories. The Xpert HIV-1 VL assay (Cepheid) was evaluated against in-country predicates, the Roche Cobas Taqmanv2 and Abbott HIV-1RT, to investigate options for expanding VL testing using GeneXpert's random access, polyvalent capabilities and already established footprint in South Africa with the Xpert MTB/RIF assay (207 sites). Additionally, the performance of Xpert HIV-1VL on alternative, off-label specimen types, Dried Blood Spots (DBS) and whole blood, was investigated.
methodPrecision, accuracy (agreement) and clinical misclassification (1000cp/ml) of Xpert HIV-1VL plasma was compared to Taqmanv2 (n = 155) and Abbott HIV-1 RT (n = 145). Misclassification of Xpert HIV-1VL was further tested on DBS (n = 145) and whole blood (n = 147).
resultsXpert HIV-1VL demonstrated 100% concordance with predicate platforms on a standardised frozen, plasma panel (n = 42) and low overall percentage similarity CV of 1.5% and 0.9% compared to Taqmanv2 and Abbott HIV-1 RT, respectively. On paired plasma clinical specimens, Xpert HIV-1VL had low bias (SD 0.32-0.37logcp/ml) and 3% misclassification at the 1000cp/ml threshold compared to Taqmanv2 (fresh) and Abbott HIV-1 RT (frozen), respectively. Xpert HIV-1VL on whole blood and DBS increased misclassification (upward) by up to 14% with increased invalid rate. All specimen testing was easy to perform and compatible with concurrent Xpert MTB/RIF Tuberculosis testing on the same instrument.
conclusionThe Xpert HIV-1VL on plasma can be used interchangeably with existing predicate platforms in South Africa. Whole blood and DBS testing requires further investigation, but polyvalency of the GeneXpert offers a solution to extending VL testing services.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.