Performance of the Alere Determine™ HIV-1/2 Ag/Ab Combo Rapid Test with algorithm-defined acute HIV-1 infection specimens

Details

• Alternative Title:
  J Clin Virol
• Personal Author:
  Parker, Monica M. ; Bennett, S. Berry ; Sullivan, Timothy J. ; Fordan, Sally ; Wesolowski, Laura G. ; Wroblewski, Kelly ; Gaynor, Anne M.
• Description:
  Background:
  
  The capacity of HIV Antigen/Antibody (Ag/Ab) immunoassays (IA) to detect HIV-1 p24 antigen has resulted in improved detection of HIV-1 infections in comparison to Ab-only screening assays. Since its introduction in the US, studies have shown that the Determine HIV-1/2 Ag/Ab Combo assay (Determine Ag/Ab) detects HIV infection earlier than laboratory-based IgM/IgG-sensitive IAs, but its sensitivity for HIV-1 p24 Ag detection is reduced compared to laboratory-based Ag/Ab assays. However, further evaluation is needed to assess its capacity to detect acute HIV-1 infection.
  
  Objective:
  
  To assess the performance of Determine Ag/Ab in serum from acute HIV-1 infections. Study design: Select serum specimens that screened reactive on a laboratory-based Ag/Ab IA or IgM/IgG Ab-only IA, with a negative or indeterminate supplemental antibody test and detectable HIV-1 RNA were retrospectively tested with Determine Ag/Ab. Results were compared with those of the primary screening immunoassay to evaluate concordance within this set of algorithm-defined acute infections.
  
  Results:
  
  Of 159 algorithm-defined acute HIV-1 specimens, Determine Ag/Ab was reactive for 105 resulting in 66.0% concordance. Of 125 that were initially detected by a laboratory-based Ag/Ab IA, 81 (64.8%) were reactive by Determine Ag/Ab. A total of 34 acute specimens were initially detected by a laboratory-based IgM/ IgG Ab-only IA and 24 (70.6%) of those were reactive by Determine Ag/Ab.
  
  Conclusions:
  
  Due to their enhanced sensitivity, laboratory-based Ag/Ab IAs continue to be preferred over the Determine Ag/Ab as the screening method used by laboratories conducting HIV diagnostic testing on serum and plasma specimens.
  
  
• Subjects:
  Algorithms HIV-1 HIV-2 HIV Antibodies HIV Antigens HIV Infections Humans Immunoassay Retrospective Studies Sensitivity And Specificity Time Factors

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• Keywords:
  Acute Infection Algorithm Determine HIV Performance
• Source:
  J Clin Virol. 104:89-91
• Pubmed ID:
  29803089
• Pubmed Central ID:
  PMC11013022
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHSUnited States/ ; U60 OE000103/OE/OSELS CDC HHSUnited States/
• Volume:
  104
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:db7c4965cae5b91f12d4170d98c4e8cfda5cd3d2e1c84e9b3a4bbbb081122533
• Download URL:
  https://stacks.cdc.gov/view/cdc/154195/cdc_154195_DS1.pdf
• File Type:
  [PDF - 52.46 KB ]