Evaluation of a rapid, point-of-care test device for the diagnosis of hepatitis C infection

J Clin Virol. 2010 May;48(1):15-7. doi: 10.1016/j.jcv.2010.02.018. Epub 2010 Apr 1.


Background: Despite considerable evolution in the quality of laboratory-based testing for detection of HCV, the availability of rapid, point-of-care tests may increase diagnoses by increasing opportunities for testing outside of traditional laboratory settings.

Objectives: We evaluated the performance of a new, rapid HCV test that can be used with venous blood, finger stick blood, serum, plasma, or oral fluid and compared it to FDA-approved laboratory methods.

Study design: HCV positive subjects as well as subjects at low risk for HCV were tested with the rapid test using all 5 specimen types and results compared to FDA-approved laboratory methods. In addition, performance was assessed in commercially available seroconversion panels.

Results: Sensitivity and specificity of the rapid test was equivalent to laboratory EIA and performance was comparable across all 5 specimen types.

Conclusions: The OraQuick HCV Rapid Antibody Test appears suitable as an aid in the diagnosis of HCV infection.

MeSH terms

  • Hepatitis C / diagnosis*
  • Hepatitis C Antibodies / analysis
  • Hepatitis C Antibodies / blood
  • Hepatitis C Antigens
  • Humans
  • Immobilized Proteins
  • Immunoenzyme Techniques / methods*
  • Point-of-Care Systems*
  • Reagent Kits, Diagnostic*
  • Sensitivity and Specificity


  • Hepatitis C Antibodies
  • Hepatitis C Antigens
  • Immobilized Proteins
  • Reagent Kits, Diagnostic