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

Autor: Lee SR; OraSure Technologies, Inc., 220 East First Street, Bethlehem, PA 18015, United States. slee@orasure.com, Yearwood GD, Guillon GB, Kurtz LA, Fischl M, Friel T, Berne CA, Kardos KW
Jazyk: angličtina
Zdroj: Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology [J Clin Virol] 2010 May; Vol. 48 (1), pp. 15-7. Date of Electronic Publication: 2010 Apr 01.
DOI: 10.1016/j.jcv.2010.02.018
Abstrakt: 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.
(Copyright 2010 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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