title: Performance evaluation of the Bio-Rad Laboratories GS HIV Combo Ag/Ab EIA, a 4th generation HIV assay for the simultaneous detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma.
abstract: BACKGROUND
  A multi-center study was conducted to evaluate the Bio-Rad GS HIV Combo Ag/Ab EIA, a 4th generation HIV-1/HIV-2 assay for the simultaneous detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma in adult and pediatric populations.
  
  
  OBJECTIVE
  The objectives of the study were to assess assay performance for the detection of acute HIV infections; sensitivity in known HIV positive samples; percent agreement with HIV status; specificity in low and high risk individuals of unknown HIV status; and to compare assay performance to a 3rd generation HIV assay.
  
  
  METHODS
  The evaluation included testing 9150 samples at four U.S. clinical trial sites, using three kit lots. Unlinked samples were from routine testing, repositories or purchased from vendors.
  
  
  RESULTS
  GS HIV Combo Ag/Ab EIA detection in samples from individuals in two separate populations with acute HIV infection was 95.2% (20/21) and 86.4% (38/44). Sensitivity was 100% (1603/1603) in known antibody positive [HIV-1 Groups M and O, and HIV-2] samples. HIV p24 antigen detection was 100% (53/53) in HIV-1 culture supernatants. HIV-1 seroconversion panel detection improved by a range of 0-20 days compared to a 3rd generation HIV test. Specificity was 99.9% (5989/5996) in low risk, 99.9% (959/960) in high risk and 100% (100/100) in pediatric populations.
  
  
  CONCLUSIONS
  The GS HIV Combo Ag/Ab EIA significantly reduced the diagnostic window when compared to the 3rd generation screening assay, enabling earlier diagnosis of HIV infection. The performance parameters of the Bio-Rad GS HIV Combo Ag/Ab EIA are well suited for use in HIV diagnostic settings.
authors: Bio-Rad Laboratories, 6565 185th Avenue NE, Redmond, WA 98052, USA. christopher bentsen@bio-rad.com
authors: Christopher
authors: C
authors: Bentsen
authors: Lisa
authors: L
authors: McLaughlin
authors: Elizabeth
authors: E
authors: Mitchell
authors: Carol
authors: C
authors: Ferrera
authors: Sally
authors: S
authors: Liska
authors: Robert
authors: R
authors: Myers
authors: Sheila
authors: S
authors: Peel
authors: Paul
authors: P
authors: Swenson
authors: Stephane
authors: S
authors: Gadelle
authors: M Kathleen
authors: MK
authors: Shriver
mesh_terms: D015483:HIV Antibodies / Q000032:analysis* / Q000097:blood / Q000276:immunology; D016655:HIV Core Protein p24 / Q000032:analysis* / Q000097:blood / Q000276:immunology; D015658:HIV Infections / Q000175:diagnosis* / Q000276:immunology / Q000821:virology; D006679:HIV Seropositivity / Q000175:diagnosis / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000276:immunology* / Q000472:pathogenicity; D015498:HIV-2 / Q000276:immunology* / Q000472:pathogenicity; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods*; D021141:Nucleic Acid Amplification Techniques; D010949:Plasma / Q000276:immunology / Q000821:virology; D011933:Reagent Kits, Diagnostic; D012307:Risk Factors; D012680:Sensitivity and Specificity; D044967:Serum / Q000276:immunology / Q000821:virology; D014481:United States
chemical_list: D015483:HIV Antibodies; D016655:HIV Core Protein p24; D011933:Reagent Kits, Diagnostic