ArticlePloS one2019
Performance and usability of Cepheid GeneXpert HIV-1 qualitative and quantitative assay in Kenya.
Article in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.
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The trial behind it
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.
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Who cites it
22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.
- 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
- Point-of-care tests detecting HIV nucleic acids for diagnosis of HIV-1 or HIV-2 infection in infants and children aged 18 months or less.The Cochrane database of systematic reviews · 2021Pooled it
- Trial
- 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
- Point-of-care HIV viral load and targeted drug resistance mutation testing versus standard care for Kenyan children on antiretroviral therapy (Opt4Kids): an open-label, randomised controlled trial.The Lancet. Child & adolescent health · 2022Trial
- Trial
- Trends of nucleic acid - based point-of-care diagnostics for infectious diseases.Journal of biological engineering · 2026Review
- Closing Diagnostic Gaps in Pediatric HIV: Innovations in Point-of-Care and Digital Monitoring with an Asia-Pacific Implementation Lens-A Systematic Review.Diagnostics (Basel, Switzerland) · 2026Review
- Optimizing hepatitis B diagnosis for mothers in a low-resource setting: A field pilot of Xpert point-of-care viral load testing in Ugandan antenatal clinics.PLOS global public health · 2026Article
- Compact multiplex PCR device for HIV-1 and HIV-2 viral load determination from finger-prick whole blood in resource-limited settings.Biosensors & bioelectronics · 2025Article
- Phenotypic markers misclassify isolates of Salmonella Typhimurium as S. Typhi, but were correctly identified by whole genome sequencing during a septicemia study in western Kenya.PLOS global public health · 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
- A handheld HIV detection platform using paper-based sample preparation and real-time isothermal amplification.Microsystems & nanoengineering · 2024Article
- Real-world performance of point-of-care vs. standard-of-care HIV viral load testing in western Kenya: Secondary analysis of Opt4Kids and Opt4Mamas studies.PLOS global public health · 2024Article
- Impact of point-of-care HIV viral load and targeted drug resistance mutation testing on viral suppression among Kenyan pregnant and postpartum women: results from a prospective cohort study (Opt4Mamas).Journal of the International AIDS Society · 2023Article
- It takes more than a machine: A pilot feasibility study of point-of-care HIV-1 viral load testing at a lower-level health center in rural western Uganda.PLOS global public health · 2023Article
- Translating diagnostics and drug delivery technologies to low-resource settings.Science translational medicine · 2022Review
- Validation of the point-of-care (POC) technologies Xpert HIV-1 Qual and m-PIMA HIV 1/2 detect for early diagnosis of HIV-1 and HIV-2 in Senegal.The Pan African medical journal · 2022Article
- Optimizing viral load suppression in Kenyan children on antiretroviral therapy (Opt4Kids).Contemporary clinical trials communications · 2020Article
- Point-of-care HIV maternal viral load and early infant diagnosis testing around time of delivery at tertiary obstetric units in South Africa: a prospective study of coverage, results return and turn-around times.Journal of the International AIDS Society · 2020Article
Corrections and comments
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn Kenya, access to early infant diagnosis and viral load monitoring services for HIV patients on ART is significantly hampered by sample transportation challenges and long turnaround times. Near patient care testing technologies have the potential to obviate such constraints. The Cepheid GeneXpert was launched in 2010 as a TB assay and in 2014 as a potential point of care HIV viral load assay. Whereas it is widely is used for TB in Kenya, its utility for HIV testing has not been evaluated.
objectiveTo investigate the performance and usability characteristics of the GeneXpert HIV-1 qualitative and quantitative assay.
methodsThis was a cross sectional study among 911 HIV Exposed infants and 310 HIV positive adults. Existing machines used for routine TB diagnosis were used in this study. The diagnostic accuracy of the qualitative assay was assessed using Roche CAP/CTM while the quantitative assay was assessed using with Abbott m2000 as the reference assays respectively. Statistical analysis was done using Stata/MP Version 14 for Mac. Concordance values and misclassification were calculated at the clinical cutoff of 1000 cp/ml.
resultsThe sensitivity, specificity and accuracy of the GeneXpert HIV-1 qualitative assay were 99.23% (95% CI 97.24-99.90%), 98.91% (95% CI 97.76-99.55%) and 99.00% respectively. For the quantitative assay, they were 92.50% (95% CI 79.61-98.43%), 100.00% and 97.00% respectively. All 30 (100%) users reported that the GeneXpert machine was easy to use, workflow was simple and TB diagnosis was not negatively affected. In our hands, the median turn-around time for an individual qualitative and quantitative test was 90 minutes. A total of 58 (4.34%) errors and 28 (2.10%) invalid outcomes were experienced; 44 (3.29%) tests did not run to completion due to power outages.
conclusionGeneXpert HIV-1 qualitative and quantitative assay is an accurate test for the diagnosis of HIV in infants and for viral load monitoring. At the point of care, the GeneXpert machine's simple work flow, ease of use and short test turnaround time present the potential to improve access to HIV testing and viral load monitoring. To integrate HIV diagnosis into the existing GeneXpert platforms for TB Diagnosis, there is need to scale up the infrastructure and to change the way work is done.
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