COLLABORATIVE STUDY TO ASSESS THE SUITABILITY OF AN HCV RNA REFERENCESAMPLE FOR DETECTION OF AN HCV RNA IN PLASMA POOLS BY PCR

A collaborative study was undertaken to examine the sensitivity and re producibility of hepatitis C virus (HCV) RNA PCR assays of plasma pool s in order to establish a reference sample for HCV PCR testing of plas ma pools. Samples consisting of an HCV-RNA-positive donation diluted t enfold in an HCV-RNA-negative cryosupernatant were sent to 16 particip ating laboratories (including blood product manufacturers and control authorities). The results of the in-house assays indicate that a 10(-4 ) dilution of the positive donation in the cryosupernatant could be us ed as the reference sample as this was the highest dilution of the pos itive donation that was detected in all assays. In contrast, the resul ts obtained with a commercially available assay, designed for use with single-donation plasma or serum (Roche Amplicor(TM) HCV test), were n ot so clear-cut and the assay appeared to be ten-fold less sensitive t han the in-house assays.