Performance of the Alere Determine™ HIV-1/2 Ag/Ab Combo Rapid Test with specimens from HIV-1 seroconverters from the US and HIV-2 infected individuals from Ivory Coast

Details

• Alternative Title:
  J Clin Virol
• Personal Author:
  Masciotra, Silvina ; Luo, Wei ; Youngpairoj, Ae S. ; Kennedy, M. Susan ; Wells, Susan ; Ambrose, Krystin ; Sprinkle, Patrick ; Owen, S. Michele
• Description:
  Background:
  
  FDA-approved HIV Antigen/Antibody combo (4th generation) immunoassays (IAs) can identify HIV-1 infections before the Western blot (WB) becomes positive. In the US, increased detection of acute HIV infections has been facilitated by using 4th generation IAs, but there is no FDA-approved 4th generation rapid test (RT). The Alere Determine™ HIV-1/2 Ag/Ab Combo (Determine Combo) RT detects and distinguishes HIV p24 Antigen (Ag) from Antibody (Ab) to HIV-1 + HIV-2 and thus has the potential to improve diagnosis of acute HIV infection.
  
  Objective:
  
  To evaluate the ability of Determine Combo RT to detect acute/early HIV-1 infections and HIV-2 antibody in well-characterized plasma specimens.
  
  Study design:
  
  In HIV-1 seroconverters from the US, Determine Combo reactivity was evaluated by performing the 50% cumulative frequency analysis and by comparing with 3rd and 4th generation IAs’ reactivity. HIV-2 plasma specimens from Ivory Coast were tested with Determine Combo.
  
  Results:
  
  The 50% cumulative frequency analysis in 17 seroconverters placed Determine Combo (Ag+/Ab−, Ag+Ab+, Ag−/Ab+) and Ab-component reactivity at 15.5 and 7 days before WB positivity, respectively. In 26 seroconverters, Determine Combo was reactive in 99.0% and 92.5% of 3rd and 4th generation IAs-reactive specimens, respectively. All HIV-2 plasma specimens were Ab-reactive/Ag-non-reactive by Determine Combo.
  
  Conclusions:
  
  Based on previous results with the same seroconversion panels, combined Ag/Ab reactivity of the Determine Combo appears between FDA-approved 4th and 3rd generation laboratory IAs. These data indicate that this RT could detect HIV-1 infection earlier than other RTs and it performs well in HIV-2 specimens.
  
  
• Subjects:
  Algorithms Diagnostic Tests, Routine HIV-1 HIV-2 HIV Antibodies HIV Antigens HIV Infections Humans Immunoassay Sensitivity And Specificity Time Factors Virology

  More +
• Keywords:
  4th Generation Diagnostic HIV-1/2 Rapid Test
• Source:
  J Clin Virol. 58(Suppl 1):e54-e58
• Pubmed ID:
  23911678
• Pubmed Central ID:
  PMC11111262
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHSUnited States/
• Place as Subject:
  Cote d'Ivoire ; United States
• Volume:
  58
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:9f63ce86be94b4d06945a1fd57405094ee414a6411071b4a46b772f5c59aea92
• Download URL:
  https://stacks.cdc.gov/view/cdc/156937/cdc_156937_DS1.pdf
• File Type:
  [PDF - 184.13 KB ]