Improvement of hepatitis C virus RNA polymerase chain reaction through a multicentre quality control study. French Study Group for the Standardization of Hepatitis C Virus PCR.
Nine French laboratories, using the polymerase chain reaction (PCR) for detection of hepatitis C virus (HCV) RNA, initiated a quality control study to assess and to improve the specificity and sensitivity of their procedures. The study was carried out in three rounds, based on coded panels consisting of anti-HCV positive and anti-HCV negative samples. For the first panel, each laboratory followed its own protocol: 100% sensitivity was observed in two laboratories, 100% specificity in seven. For the second panel, all laboratories were required to use both their own procedure and a consensus procedure established from those laboratories which provided the best results on the first panel. With their own procedure, 100% sensitivity was observed in five laboratories and 100% specificity in all. With the common procedure, 100% sensitivity was observed in all but one, and 100% specificity in all. The third panel included three positive samples with four successive dilutions. For two samples, 8/8 laboratories had positive signals until the 1/100 dilution and discrepant results beyond this dilution; for the third sample, the signals were more discrepant. These results indicate that optimization and standardization of PCR may help laboratories to improve their procedure.
D001483:Base Sequence; D017931:DNA Primers / Q000235:genetics; D004279:DNA, Viral / Q000235:genetics; D005602:France; D016174:Hepacivirus / Q000235:genetics* / Q000302:isolation & purification*; D006526:Hepatitis C / Q000175:diagnosis* / Q000821:virology; D006801:Humans; D008969:Molecular Sequence Data; D016133:Polymerase Chain Reaction / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data; D011786:Quality Control; D012367:RNA, Viral / Q000097:blood / Q000235:genetics* / Q000302:isolation & purification*; D012680:Sensitivity and Specificity; D014773:Virology / Q000379:methods
D017931:DNA Primers; D004279:DNA, Viral; D012367:RNA, Viral