ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2020
Performance evaluation of the MedMira reveal G4 LAB S/P and POC HIV antibody rapid screening tests using plasma and whole blood specimens.
Article in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed, 5 citations in OpenAlex.
- 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
- A handheld HIV detection platform using paper-based sample preparation and real-time isothermal amplification.Microsystems & nanoengineering · 2024Article
- Review of HIV Self Testing Technologies and Promising Approaches for the Next Generation.Biosensors · 2023Review
- The contemporary immunoassays for HIV diagnosis: a concise overview.Asian biomedicine : research, reviews and news · 2023Review
- Point-of-Care Diagnostic forPathogens (Basel, Switzerland) · 2023Article
Corrections and comments
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Authors and funding
4 authors at 2 institutions in 3 countries.
Funding
Abstract
backgroundThe Reveal G4 antibody rapid test is FDA-approved for HIV-1 detection using the versions LAB S/P and POC in CLIA-moderate complexity settings with serum/plasma and whole blood, respectively. The same Reveal tests are CE-marked for HIV-1 and HIV-2 detection in laboratory and point-of-care (POC) settings.
objectiveWe compared the performance of G4 LAB S/P with plasma and POC with whole blood (blood) for detecting early and established HIV-1/HIV-2 infections. STUDY
designMatched well-characterized plasma and simulated blood were used to evaluate: sensitivity in 104 HIV-1 and 55 HIV-2 established infections, specificity in 49 HIV-negative, and reactivity in early HIV-1 infection in a performance panel (n=38) and 18 plasma panels from seroconverters (SCs, n=183). Median number of days after first RNA-positive was calculated for 13 SCs. Impact of viral suppression (VS) was evaluated in 3 SCs receiving early antiretroviral therapy (ART).
resultsSensitivity was 100 % for HIV-1 and 98.18 % for HIV-2, while specificity was 100 %. All 38 plasma and blood become reactive by Fiebig stage V. Of 18 SCs, 10 had similar reactivity in plasma/blood, 7 showed delayed reactivity in blood, and 1 was nonreactive in plasma/blood. The median days for a G4-reactive after first RNApositive was 13 for plasma and 14 for blood. Long-term VS had no impact on G4 reactivity.
conclusionsOverall reactivity in early HIV-1 infections is delayed by one day in blood compared to plasma. If FDA-approved for POC settings, the G4 POC is a fast sensitive screening tool for HIV-1/HIV-2-specific IgG even during VS.
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Registered trials
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