title: Field-based performance of three pre-market rapid hepatitis C virus antibody assays in STAHR (Study to Assess Hepatitis C Risk) among young adults who inject drugs in San Diego, CA.
abstract: BACKGROUND
  Approximately 4.1 million Americans are estimated to have been infected with hepatitis C virus (HCV), 45-85% of whom are unaware of their infection. Persons who inject drugs (PWID) account for 55.8% of all persons with HCV antibody (anti-HCV) in the U.S. PWID have limited access to healthcare and are infrequently tested for anti-HCV using conventional laboratory assays.
  
  
  OBJECTIVE
  To evaluate performance characteristics (sensitivity and specificity) of three, pre-market rapid point-of-care tests (one oral fluid and two finger-stick assays) from two manufacturers (Chembio and MedMira) in settings providing services to young adult PWID in San Diego, CA.
  
  
  METHODS
  Behavioral risk assessment surveys and testing for HCV were conducted among persons who reported injection drug use (IDU) within the past 6 months as part of the Study to Assess Hepatitis C Risk (STAHR) among PWID aged 18-40 years in 2009-2010. Sensitivity and specificity of the rapid anti-HCV assays were evaluated among STAHR participants, using two commonly used testing algorithms.
  
  
  RESULTS
  Variability in sensitivity (76.6-97.1%) and specificity (99.0-100.0%) was found across assays. The highest sensitivity achieved for the Chembio finger-stick blood, Chembio oral fluid and MedMira finger-stick blood tests was 97.1%, 85.4% and 80.0% respectively; the highest specificity was 99.0%, 100.0% and 100.0%, respectively. In multivariate analysis false negative anti-HCV results were associated with female sex for the MedMira blood assay.
  
  
  CONCLUSIONS
  Sensitive anti-HCV rapid assays are appropriate and feasible for high-prevalence, high-risk populations such as young PWID.
authors.affiliation: Oak Ridge Institute for Science and Education, Clinton, TN, USA. ACJewett@cdc.gov
authors.forename: A
authors.initials: A
authors.lastname: Jewett
authors.forename: B D
authors.initials: BD
authors.lastname: Smith
authors.forename: R S
authors.initials: RS
authors.lastname: Garfein
authors.forename: J
authors.initials: J
authors.lastname: Cuevas-Mota
authors.forename: E H
authors.initials: EH
authors.lastname: Teshale
authors.forename: C M
authors.initials: CM
authors.lastname: Weinbaum
mesh_terms: D000293:Adolescent; D000328:Adult; D019411:Clinical Laboratory Techniques / Q000379:methods*; D005260:Female; D016174:Hepacivirus / Q000276:immunology*; D006526:Hepatitis C / Q000175:diagnosis*; D018937:Hepatitis C Antibodies / Q000097:blood*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D008297:Male; D019095:Point-of-Care Systems; D012680:Sensitivity and Specificity; D015819:Substance Abuse, Intravenous / Q000150:complications; D013997:Time Factors; D014481:United States; D014773:Virology / Q000379:methods*; D055815:Young Adult
chemical_list: D018937:Hepatitis C Antibodies