title: 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.
abstract: 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.
  
  
  METHODS
  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.
authors.affiliation: Laboratory Branch, Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States. Electronic address: svm6@cdc.gov.
authors.forename: Silvina
authors.initials: S
authors.lastname: Masciotra
authors.affiliation: Laboratory Branch, Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States.
authors.forename: Wei
authors.initials: W
authors.lastname: Luo
authors.affiliation: Laboratory Branch, Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States.
authors.forename: Ae S
authors.initials: AS
authors.lastname: Youngpairoj
authors.affiliation: Laboratory Branch, Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States.
authors.forename: M Susan
authors.initials: MS
authors.lastname: Kennedy
authors.affiliation: Laboratory Branch, Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States.
authors.forename: Susan
authors.initials: S
authors.lastname: Wells
authors.affiliation: Laboratory Branch, Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States.
authors.forename: Krystin
authors.initials: K
authors.lastname: Ambrose
authors.affiliation: Laboratory Branch, Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States.
authors.forename: Patrick
authors.initials: P
authors.lastname: Sprinkle
authors.affiliation: Laboratory Branch, Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States.
authors.forename: S Michele
authors.initials: SM
authors.lastname: Owen
mesh_terms: D000465:Algorithms; D007560:Cote d'Ivoire; D003955:Diagnostic Tests, Routine / Q000379:methods*; D015483:HIV Antibodies / Q000097:blood*; D015488:HIV Antigens / Q000097:blood*; D015658:HIV Infections / Q000175:diagnosis* / Q000821:virology; D015497:HIV-1 / Q000145:classification* / Q000235:genetics / Q000276:immunology; D015498:HIV-2 / Q000145:classification* / Q000235:genetics / Q000276:immunology; D006801:Humans; D007118:Immunoassay / Q000379:methods; D012680:Sensitivity and Specificity; D013997:Time Factors; D014481:United States; D014773:Virology / Q000379:methods
chemical_list: D015483:HIV Antibodies; D015488:HIV Antigens
keywords: 4th generation; Diagnostic; HIV-1/2; Rapid test
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