IMPROVEMENT OF HEPATITIS-C VIRUS-RNA POLYMERASE CHAIN-REACTION THROUGH A MULTICENTER QUALITY-CONTROL STUDY

Nine French laboratories, using the polymerase chain reaction (PCR) fo r detection of hepatitis C virus (HCV) RNA, initiated a quality contro l study to assess and to improve the specificity and sensitivity of th eir procedures. The study was carried out in three rounds, based on co ded panels consisting of anti-HCV positive and anti-HCV negative sampl es. For the first panel, each laboratory followed its own protocol: 10 0% sensitivity was observed in two laboratories, 100% specificity in s even. 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 laboratorie s and 100% specificity in all. With the common procedure, 100% sensiti vity was observed in all but one, and 100% specificity in all. The thi rd panel included three positive samples with four successive dilution s. For two samples, 8/8 laboratories had positive signals until the 1/ 100 dilution and discrepant results beyond this dilution; for the thir d sample, the signals were more discrepant. These results indicate tha t optimization and standardization of PCR may help laboratories to imp rove their procedure.