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Eur J Gastroenterol Hepatol. 2013 Apr;25(4):416-20. doi: 10.1097/MEG.0b013e32835c502d.

Evaluation of a rapid on-site anti-HCV test as a screening tool for hepatitis C virus infection.

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  • 1Department of Internal Medicine, Dermatology and Neurology, Clinic of Gastroenterology and Rheumatology, Section of Hepatology, University of Leipzig, Liebigstr. 20, 04103 Leipzig, Germany.

Abstract

BACKGROUND:

In settings such as needle-stick injuries or intravenous drug abuse, immediate knowledge of the anti-hepatitis C virus (HCV) serostatus instead of waiting for the results of a laboratory-based test can be important to guide further medical procedures and appropriate hygienic advises. Thus, a rapid on-site anti-HCV test was evaluated in daily clinical routine and compared with a laboratory-based certified assay.

PATIENTS AND METHODS:

Ten microliters of serum or EDTA whole blood was analyzed using a chromatographic immunoassay (Toyo anti-HCV test). Results were available on-site 5-15 min after sample centrifugation. The Architect anti-HCV test served as a reference method.

RESULTS:

Sera of 189 patients were analyzed (without HCV infection: n=105; HCV infection: n=84). The assay was evaluable in 185 cases (98%). The sensitivity and specificity were 99 and 88%, respectively. With EDTA whole blood, the test was evaluable in 47/52 samples (90%). Forty-six of 47 evaluable EDTA tests were concordant with serum results. The one HCV patient with an unevaluable serum test was diagnosed correctly with the EDTA sample.

CONCLUSION:

The rapid chromatographic anti-HCV immunoassay has limited specificity, which impairs clinical practicability. A positive result warrants re-evaluation with a certified serologic assay.

PMID:
23211286
[PubMed - indexed for MEDLINE]
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