title: Reliability of polymerase chain reaction for detection of hepatitis C virus.
abstract: The polymerase chain reaction (PCR) is used to detect hepatitis C virus (HCV) RNA, and the results of this assay may have a bearing on management of patients. We tested 31 laboratories for performance of HCV PCR with a coded panel that comprised 4 HCV-positive plasma samples, 6 HCV-negative samples, and two dilution series of HCV-positive plasma. 15 (48%) laboratories had faultless results with both dilution series, and 16 (52%) laboratories reported erroneous results with one or both series. 10 (32%) laboratories had faultless results when testing undiluted plasma samples, 11 (35%) produced a false-negative result with a weak-positive sample, and 10 (32%) produced false negative and/or false positive results. Only 5 (16%) laboratories performed faultlessly with the entire panel of samples. Reports of presence of HCV should be interpreted with care until reliable HCV-RNA detection becomes widely available.
authors.affiliation: Central Laboratory of the Netherlands Red Cross Blood Transfusion Service, Amsterdam, Netherlands.
authors.forename: H L
authors.initials: HL
authors.lastname: Zaaijer
authors.forename: H T
authors.initials: HT
authors.lastname: Cuypers
authors.forename: H W
authors.initials: HW
authors.lastname: Reesink
authors.forename: I N
authors.initials: IN
authors.lastname: Winkel
authors.forename: G
authors.initials: G
authors.lastname: Gerken
authors.forename: P N
authors.initials: PN
authors.lastname: Lelie
mesh_terms: D019411:Clinical Laboratory Techniques / Q000592:standards; D005188:False Negative Reactions; D005189:False Positive Reactions; D016174:Hepacivirus; D006526:Hepatitis C / Q000175:diagnosis*; D006801:Humans; D007753:Laboratories / Q000592:standards*; D016133:Polymerase Chain Reaction / Q000592:standards*; D012367:RNA, Viral / Q000032:analysis*; D015203:Reproducibility of Results; D012106:Research
chemical_list: D012367:RNA, Viral