Evaluation of a Rapid, Point-of-Care Test Device for the Diagnosis of Hepatitis C Infection

Publication/Presentation Date

5-2010

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.

Volume

48

Issue

1

First Page

15

Last Page

17

ISSN

1873-5967

Disciplines

Infectious Disease | Medical Sciences | Medical Specialties | Medicine and Health Sciences

PubMedID

20362493

Department(s)

Department of Medicine

Document Type

Article

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