title: Clinical specificity and sensitivity of a blood screening assay for detection of HIV-1 and HCV RNA.
abstract: BACKGROUND
  An HIV-1 and HCV NAT blood screening assay (Procleix HIV-1/HCV, Gen-Probe, Inc.) simultaneously detecting HIV-1 and HCV RNA) has been implemented. Donor plasma samples reactive in the Procleix HIV-1/HCV assay are tested with the HIV-1 and HCV discriminatory assays to resolve whether HIV-1 RNA, HCV RNA, or both are present.
  
  
  METHODS
  To determine the specificity of the Procleix HIV-1/HCV assay, data were analyzed for samples from 192,288 donations, tested in 16-member pools. To determine sensitivity, data were analyzed for 2014 commercial samples known to contain HIV-1, HCV, or both, as well as 10 HIV-1 and 10 HCV commercial seroconversion panels.
  
  
  RESULTS
  The specificity of the Procleix HIV-1/HCV assay was 99.7 percent. The HIV-1 and HCV discriminatory assays showed similar specificity. The sensitivity of the Procleix HIV-1/HCV assay was 99.9, 99.6, and 100 percent, respectively, for samples containing HIV-1, HCV, or both. The Procleix discriminatory assays were comparably sensitive. The Procleix discriminatory assays detected all tested samples of known HIV-1 subtype or HCV genotype. Procleix HIV-1/HCV testing of seroconversion panels showed that the median times to a positive reaction for HIV-1 and HCV were reduced by 3 and 25 days, respectively, compared to serologic tests.
  
  
  CONCLUSIONS
  These studies support the use of the Procleix HIV-1/HCV assay for routine blood donor screening.
authors.affiliation: Gen-Probe Incorporated, San Diego, California 92121, USA. janetv@gen-probe.com
authors.forename: Janet
authors.initials: J
authors.lastname: Vargo
authors.forename: Katie
authors.initials: K
authors.lastname: Smith
authors.forename: Caroline
authors.initials: C
authors.lastname: Knott
authors.forename: Songbai
authors.initials: S
authors.lastname: Wang
authors.forename: Chyang
authors.initials: C
authors.lastname: Fang
authors.forename: Sherrol
authors.initials: S
authors.lastname: McDonough
authors.forename: Cristina
authors.initials: C
authors.lastname: Giachetti
authors.forename: Sally
authors.initials: S
authors.lastname: Caglioti
authors.forename: Richard
authors.initials: R
authors.lastname: Gammon
authors.forename: Denise
authors.initials: D
authors.lastname: Gilbert
authors.forename: J Brooks
authors.initials: JB
authors.lastname: Jackson
authors.forename: William
authors.initials: W
authors.lastname: Richards
authors.forename: Susan
authors.initials: S
authors.lastname: Stramer
authors.forename: Larry
authors.initials: L
authors.lastname: Mimms
mesh_terms: D001769:Blood / Q000821:virology; D001782:Blood Donors; D005838:Genotype; D015658:HIV Infections / Q000175:diagnosis / Q000635:transmission; D006679:HIV Seropositivity; D015497:HIV-1 / Q000235:genetics*; D016174:Hepacivirus / Q000235:genetics*; D006526:Hepatitis C / Q000175:diagnosis / Q000635:transmission; D006801:Humans; D008403:Mass Screening; D021141:Nucleic Acid Amplification Techniques / Q000592:standards*; D011237:Predictive Value of Tests; D012367:RNA, Viral / Q000097:blood*; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012680:Sensitivity and Specificity
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic