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Journal of Clinical Microbiology, Feb 1995, 477-480, Vol 33, No. 2
Copyright © 1995 by the American Society for Microbiology. All rights reserved.

Evaluation of SHARP signal system for enzymatic detection of amplified hepatitis B virus DNA

E Valentine-Thon
Labor Schiwara, von Winterfeld, Pfanzelt, Kunz, Bremen, Germany.

The sensitivity, specificity, reproducibility, detection level, and quantification potential of the SHARP Signal System for enzymatic detection of amplified hepatitis B virus (HBV) DNA in clinical samples were evaluated by testing 104 samples in parallel in a SHARP PCR, an in- house HBV PCR, and a dot blot hybridization assay for semiquantification. SHARP PCR showed a sensitivity of 100%, a specificity of 92.3% (resolved, 100%), a reproducibility of 92.3% (all discrepant serum samples involved very low levels of HBV DNA), and a detection level of at least 3.5 pg/ml. Clinically relevant quantification of the amplified products was not feasible.

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