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

Details

• Alternative Title:
  J Clin Virol
• Personal Author:
  Rossetti, Rebecca ; Smith, Tara ; Luo, Wei ; Masciotra, Silvina
• 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.
  
  
• Subjects:
  HIV-1 HIV-2 HIV Antibodies HIV Infections HIV Seropositivity Humans Point-of-Care Testing Reagent Kits, Diagnostic Sensitivity And Specificity Serologic Tests
• Keywords:
  HIV Diagnostics Rapid Test
• Source:
  J Clin Virol. 127:104344
• Pubmed ID:
  32305880
• Pubmed Central ID:
  PMC7404553
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHSUnited States/
• Volume:
  127
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:e20705aaac27a2941cbb9985c5e91e65f298c6a89035b22c0e73beba2e712929
• Download URL:
  https://stacks.cdc.gov/view/cdc/91700/cdc_91700_DS1.pdf
• File Type:
  [PDF - 168.38 KB ]