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.