title: Reliability of methods for hepatitis B virus DNA detection.
abstract: A quality assurance program has been established by the European Group for Rapid Viral Diagnosis and the European Expert Group on Viral Hepatitis for monitoring nucleic acid detection methods for hepatitis B virus (HBV) DNA in serum samples. Thirty-nine laboratories participated in this quality program and generated 43 data sets. Of the participating laboratories, all but one used the PCR technique to detect HBV DNA. A coded panel was tested that was composed of seven undiluted HBV DNA-positive serum samples and five HBV DNA-negative donor serum samples. Furthermore, two dilution series, one from a positive patient and one from a full-length recombinant DNA, were included. Twenty-six data sets (60.5%) had faultless results with both dilution series. Twelve data sets (27.9%) recognized the undiluted serum samples, and 19 data sets (44.2%) had false-negative and/or false-positive results. Ten data sets (23.3%) performed well with the entire panel of samples. From these results, it can be concluded that in a large group of laboratories HBV detection by PCR shows specificity and sensitivity problems; therefore, PCR test interpretation should be done with great care.
authors.affiliation: Department of Molecular Biology, Diagnostic Center SSDZ, Delft, The Netherlands.
authors.forename: W G
authors.initials: WG
authors.lastname: Quint
authors.forename: R A
authors.initials: RA
authors.lastname: Heijtink
authors.forename: J
authors.initials: J
authors.lastname: Schirm
authors.forename: W H
authors.initials: WH
authors.lastname: Gerlich
authors.forename: H G
authors.initials: HG
authors.lastname: Niesters
mesh_terms: D004279:DNA, Viral / Q000097:blood*; D005188:False Negative Reactions; D005189:False Positive Reactions; D006509:Hepatitis B / Q000097:blood / Q000175:diagnosis*; D006511:Hepatitis B Antigens / Q000097:blood; D006801:Humans; D016133:Polymerase Chain Reaction / Q000379:methods*; D011786:Quality Control; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D004279:DNA, Viral; D006511:Hepatitis B Antigens