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☆

Details

• Alternative Title:
  J Clin Virol
• Personal Author:
  Jewett, A. ; Smith, B.D. ; Garfein, R.S. ; Cuevas-Mota, J. ; Teshale, E.H. ; Weinbaum, C.M.
• Description:
  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. ; Study design ; 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.
• Subjects:
  • Adolescent
  • Adult
  • Clinical Laboratory Techniques
  • Female
  • Hepacivirus
  • Hepatitis C Antibodies
  • Humans
  • Immunoassay
  • Male
  • Point-of-Care Systems
  More +
• Source:
  J Clin Virol. 54(3):213-217.
• Pubmed ID:
  22560051
• Pubmed Central ID:
  PMC5484575
• Document Type:
  Journal Article
• Funding:
  CC999999/Intramural CDC HHS/United States
• Place as Subject:
  United States
• Volume:
  54
• Issue:
  3
• Download URL:
  https://stacks.cdc.gov/view/cdc/46441/cdc_46441_DS1.pdf
• File Type:
  [PDF - 321.94 KB]
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:216bcf9d0552539c72544d69d261fadb57a4d5fee22c28daa787011076fd2455