Performance and Utility of a Rapid, Point of Care Test for Hepatitis C Using Oral Fluid, Blood, Serum and Plasma

Wednesday, March 12, 2008
Continental Ballroom
Stephen R. Lee, PhD , Research & Development, OraSure Technologies, Inc, Bethlehem, PA
Keith W. Kardos, PhD , Research & Development, OraSure Technologies, Inc, Bethlehem, PA
Graham Yearwood, PhD , Research & Development, OraSure Technologies, Inc, Bethlehem, PA
Geraldine Guillon, PhD , Research & Development, OraSure Technologies, Inc, Bethlehem, PA
Lisa Kurtz , Research & Development, OraSure Technologies, Inc, Bethlehem, PA
Mark Fischl , Research & Development, OraSure Technologies, Inc, Bethlehem, PA
Vijaya Mokkapati , Research & Development, OraSure Technologies, Inc, Bethlehem, PA

Background:
There is currently no rapid, point of care (POC) test for hepatitis C infection available in the US and all diagnostic testing is carried out in a laboratory setting. We have developed a prototype POC test for the detection of antibodies to hepatitis C virus (HCV) using the OraQuick rapid test platform, suitable for use with blood, oral fluid, serum or plasma.

Objective:
To evaluate the clinical performance of this prototype rapid HCV test compared to current laboratory-based tests in settings of symptomatic hepatitis and populations at risk for hepatitis C infection.

Method:
Sensitivity was assessed in plasma specimens from sero-positive individuals, chronic HCV infection, individuals undergoing seroconversion, HIV/HCV coinfection and a worldwide panel representing all major genotypes and subtypes. Sensitivity and specificity in human subjects was assessed in a presumptive HCV positive population, as well as population of unknown or low risk.

Result:
All specimens from known sero-positives (n=479), chronic infection (n=67) and HIV/HCV coinfection (n=34) were detected by the laboratory EIA and OraQuick. Time to detection of seroconversion (n=22 panels) was an average of +3.2 days earlier (95%CIs: -1.4 to + 5.1) by OraQuick. Results were concordant between EIA and OraQuick for all HCV genotypes and subtypes tested (n=35). OraQuick results were concordant across all 5 specimen types in the low risk population (n=419). Specificity was 99.8% with three individuals prospectively identified as having anti-HCV. All individuals presumed to be infected with HCV (n=92) were detected by OraQuick and EIA.

Conclusion:
Clinical performance of the prototype OraQuick HCV POC test with all specimen types was equivalent to state of the art, laboratory based tests.

Implications:
Widespread deployment of a rapid POC test for HCV would identify currently undiagnosed HCV infection, allowing therapeutic intervention and mitigation of future disease burden in the US.
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