title: Performance evaluation of the FDA-approved Determine™ HIV-1/2 Ag/Ab Combo assay using plasma and whole blood specimens.
abstract: The Determine™ HIV-1/2 Ag/Ab Combo (DC) rapid test can identify HIV-1 infection earlier than rapid antibody-only tests in plasma specimens.
  
  
  
  We compared the performance of DC with a laboratory-based antigen/antibody (Ag/Ab) combo assay in plasma and evaluated antigen reactivity in whole blood specimens.
  
  
  
  We tested by DC 508 plasma specimens collected in a prospective study and 107 sequential plasma and simulated whole blood specimens from 20 seroconversion panels. Previous results using the ARCHITECT (ARC) Ag/Ab combo assay were compared to DC results. In seroconversion panels, the days from the first HIV1 RNA-positive test to first DC-reactive in plasma and whole blood was compared. McNemar's and Wilcoxon signed rank tests were used for statistical analysis.
  
  
  
  Of 415 HIV-positive samples, ARC detected 396 (95.4%) and DC 337 (81.2%) (p<0.0001). DC was reactive in 50.0% of ARC-reactive/MS-negative, 78.6% of ARC-reactive/MS-indeterminate, and 99.6% of ARC-reactive/MS-HIV-1-positive or -undifferentiated specimens. DC antigen reactivity was higher among ARC-reactive/MS-negative than MS-indeterminate samples. In 20 HIV-1 seroconversion panels, there was a significant difference between DC reactivity in plasma (91.1%) and whole blood (56.4%) (p<0.0001). DC with whole blood showed a significant delay in reactivity compared to plasma (p=0.008).
  
  
  
  In plasma, DC was significantly less sensitive than an instrumented laboratory-based Ag/Ab combo assay. DC in plasma was significantly more sensitive compared to whole blood in early HIV-1 infections. With the U.S. laboratory-based diagnostic algorithm, DC as the first step would likely miss a high proportion of HIV-1 infections in early stages of seroconversion.
authors.affiliation: 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: 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: New York City Department of Health & Mental Hygiene, New York City, NY, United States.
authors.forename: Emily
authors.initials: E
authors.lastname: Westheimer
authors.affiliation: San Francisco Department of Public Health, San Francisco, CA, United States.
authors.forename: Stephanie E
authors.initials: SE
authors.lastname: Cohen
authors.affiliation: University of North Carolina, Chapel Hill, NC, United States.
authors.forename: Cynthia L
authors.initials: CL
authors.lastname: Gay
authors.affiliation: ICF International, Atlanta, GA, United States.
authors.forename: Laura
authors.initials: L
authors.lastname: Hall
authors.affiliation: Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States.
authors.forename: Yi
authors.initials: Y
authors.lastname: Pan
authors.affiliation: Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States.
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Peters
authors.affiliation: 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: D015492:AIDS Serodiagnosis; D015483:HIV Antibodies / Q000097:blood* / Q000276:immunology; D015488:HIV Antigens / Q000097:blood* / Q000276:immunology; D015658:HIV Infections / Q000175:diagnosis* / Q000453:epidemiology / Q000821:virology; D006679:HIV Seropositivity; D015497:HIV-1 / Q000276:immunology / Q000302:isolation & purification; D015498:HIV-2 / Q000276:immunology / Q000302:isolation & purification; D006801:Humans; D007118:Immunoassay; D008403:Mass Screening; D010949:Plasma / Q000821:virology; D011446:Prospective Studies; D011933:Reagent Kits, Diagnostic; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015483:HIV Antibodies; D015488:HIV Antigens; D011933:Reagent Kits, Diagnostic
keywords: Antigen-antibody detection; HIV diagnostics; Rapid test