ArticleJournal of clinical microbiology2016
Evaluation of the Whole-Blood Alere Q NAT Point-of-Care RNA Assay for HIV-1 Viral Load Monitoring in a Primary Health Care Setting in Mozambique.
Article in Journal of clinical microbiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 2 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
34 citing papers in PubMed, 2 syntheses or guidelines pooled it, 41 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
- Systematic review of the performance and clinical utility of point of care HIV-1 RNA testing for diagnosis and care.PloS one · 2019Pooled it
- Impact of Point-of-Care Birth Test-and-Treat on Clinical Outcomes Among Infants With HIV: A Cluster-Randomized Trial in Mozambique and Tanzania.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Trial
- Point-of-care HIV viral load testing combined with task shifting to improve treatment outcomes (STREAM): findings from an open-label, non-inferiority, randomised controlled trial.The lancet. HIV · 2020Trial
- Trial
- Increases in total HIV-1 nucleic acid in whole blood precede plasma RNA rebound during pediatric analytical treatment interruption.AIDS (London, England) · 2026Article
- The Critical Importance of Clinical Use Case to Inform Point-of-Care Technology Development: A Case Study of HIV Nucleic Acid Assays in the United States.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- A luminescence-based point-of-care HIV viral load test for antiretroviral therapy monitoring.Lab on a chip · 2025Article
- Study design and procedures for a hybrid effectiveness-implementation incomplete stepped-wedge cluster-randomized trial to evaluate a differentiated point-of-care HIV diagnosis and management model for the prevention of vertical transmission of HIV in Malawi: The PAC-Man trial protocol.Implementation science communications · 2025Article
- An Ultracompact Real-Time Fluorescence Loop-Mediated Isothermal Amplification (LAMP) Analyzer.Methods in molecular biology (Clifton, N.J.) · 2022Article
- Current state of commercial point-of-care nucleic acid tests for infectious diseases.The Analyst · 2021Review
- Study To Evaluate the Performance of a Point-of-Care Whole-Blood HIV Viral Load Test (SAMBA II HIV-1 Semi-Q Whole Blood).Journal of clinical microbiology · 2021Article
- HIV infection in Eastern and Southern Africa: Highest burden, largest challenges, greatest potential.Southern African journal of HIV medicine · 2021Article
- An open-source molecular diagnostic platform approach for outbreak and epidemic preparedness.African journal of laboratory medicine · 2020Article
- Comparison of Alere q whole blood viral load with DBS and plasma viral load in the classification of HIV virological failure.PloS one · 2020Article
- Challenges of HIV diagnosis and management in the context of pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), test and start and acute HIV infection: a scoping review.Journal of the International AIDS Society · 2019Article
- Field Suitability and Diagnostic Accuracy of the Biocentric Open Real-Time PCR Platform for Dried Blood Spot-Based HIV Viral Load Quantification in Eswatini.Journal of acquired immune deficiency syndromes (1999) · 2019Article
- Point-of-Care HIV Viral Load Testing: an Essential Tool for a Sustainable Global HIV/AIDS Response.Clinical microbiology reviews · 2019Review
- Nucleic acid testing and molecular characterization of HIV infections.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2019Review
- An updated roadmap for MERS-CoV research and product development: focus on diagnostics.BMJ global health · 2019Article
Corrections and comments
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Authors and funding
11 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Viral load testing is the WHO-recommended monitoring assay for patients on HIV antiretroviral therapy (ART). Point-of-care (POC) assays may help improve access to viral load testing in resource-limited settings. We compared the performance of the Alere Q NAT POC viral load technology (Alere Technologies, Jena, Germany), measuring total HIV RNA using finger prick capillary whole-blood samples collected in a periurban health center, with that of a laboratory-based plasma RNA test (Roche Cobas Ampliprep/Cobas TaqMan v2) conducted on matched venous blood samples. The whole-blood Alere Q NAT POC assay produced results with a bias of 0.8593 log copy/ml compared to the laboratory-based plasma assay. However, at above 10,000 copies/ml, the bias was 0.07 log copy/ml. Using the WHO-recommended threshold to determine ART failure of 1,000 copies/ml, the sensitivity and specificity of the whole-blood Alere Q NAT POC assay were 96.83% and 47.80%, respectively. A cutoff of 10,000 copies/ml of whole blood with the Alere Q NAT POC assay appears to be a better predictor of ART failure threshold (1,000 copies/ml of plasma), with a sensitivity of 84.0% and specificity of 90.3%. The precision of the whole-blood Alere Q NAT POC assay was comparable to that observed with the laboratory technology (5.4% versus 7.5%) between detectable paired samples. HIV POC viral load testing is feasible at the primary health care level. Further research on the value of whole-blood viral load to monitor antiretroviral therapy is warranted.
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Registered trials
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.