Reliability of polymerase chain reaction for detection of hepatitis C virus

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,...

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Bibliographic Details
Published in:The Lancet (British edition) 1993-03, Vol.341 (8847), p.722-724
Main Authors: Zaaijer, H.L., Cuypers, H.T.M., Reesink, H.W., Winkel, I.N., Lelie, P.N., Gerken, G.
Format: Article
Language:English
Subjects:
Biological and medical sciences
Clinical Laboratory Techniques - standards
Digestive system
False Negative Reactions
False Positive Reactions
Hepacivirus
Hepatitis
Hepatitis C
Hepatitis C - diagnosis
Humans
Investigative techniques, diagnostic techniques (general aspects)
Laboratories
Laboratories - standards
Medical research
Medical sciences
Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques
Polymerase Chain Reaction - standards
Reproducibility of Results
Ribonucleic acid
RNA
RNA, Viral - analysis
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Summary: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.
ISSN:0140-6736
1474-547X
DOI:10.1016/0140-6736(93)90488-3