title: Evaluation of SHARP signal system for enzymatic detection of amplified hepatitis B virus DNA.
abstract: 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.
authors.affiliation: Labor Schiwara, von Winterfeld, Pfanzelt, Kunz, Bremen, Germany.
authors.forename: E
authors.initials: E
authors.lastname: Valentine-Thon
mesh_terms: D001483:Base Sequence; D001710:Biotin; D017931:DNA Primers / Q000235:genetics; D015342:DNA Probes; D004279:DNA, Viral / Q000097:blood* / Q000235:genetics*; D005069:Evaluation Studies as Topic; D005784:Gene Amplification; D006509:Hepatitis B / Q000175:diagnosis / Q000382:microbiology; D006515:Hepatitis B virus / Q000235:genetics* / Q000302:isolation & purification*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000706:statistics & numerical data; D008969:Molecular Sequence Data; D016133:Polymerase Chain Reaction / Q000379:methods* / Q000706:statistics & numerical data; D012680:Sensitivity and Specificity; D014766:Viremia / Q000175:diagnosis / Q000382:microbiology; D014773:Virology / Q000379:methods* / Q000706:statistics & numerical data
chemical_list: D017931:DNA Primers; D015342:DNA Probes; D004279:DNA, Viral; D001710:Biotin