Performance Evaluation of the MedMira Reveal G4 LAB S/P and POC HIV Antibody Rapid Screening Tests using Plasma and Whole Blood Specimens
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Performance Evaluation of the MedMira Reveal G4 LAB S/P and POC HIV Antibody Rapid Screening Tests using Plasma and Whole Blood Specimens

  • Published Date:

    April 11 2020

  • Source:
    J Clin Virol. 127:104344
  • Language:
    English
Filetype[PDF-168.38 KB]


Details:
  • Alternative Title:
    J Clin Virol
  • Description:
    Background The 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. Objective We 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 design Matched 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). Results Sensitivity 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 RNA-positive was 13 for plasma and 14 for blood. Long-term VS had no impact on G4 reactivity. Conclusions Overall 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.
  • Pubmed ID:
    32305880
  • Pubmed Central ID:
    PMC7404553
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