Evaluation of a Rapid, Point-of-Care Test Device for the Diagnosis of Hepatitis C Infection
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.
Published In/Presented At
Lee, S., Yearwood, G., Guillon, G., Kurtz, L., Fischl, M., Friel, T., & ... Kardos, K. (2010). Evaluation of a rapid, point-of-care test device for the diagnosis of hepatitis C infection. Journal Of Clinical Virology: The Official Publication Of The Pan American Society For Clinical Virology, 48(1), 15-17. doi:10.1016/j.jcv.2010.02.018
Infectious Disease | Medical Sciences | Medical Specialties | Medicine and Health Sciences
Department of Medicine