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

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

Author information

1
OraSure Technologies, Inc., 220 East First Street, Bethlehem, PA 18015, United States. slee@orasure.com

Abstract

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.

PMID:
20362493
DOI:
10.1016/j.jcv.2010.02.018
[Indexed for MEDLINE]

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