Collaborative study to assess the suitability of an HCV RNA reference sample for detection of an HCV RNA in plasma pools by PCR.

A collaborative study was undertaken to examine the sensitivity and reproducibility of hepatitis C virus (HCV) RNA PCR assays of plasma pools in order to establish a reference sample for HCV PCR testing of plasma pools. Samples consisting of an HCV-RNA-positive donation diluted tenfold in an HCV-RNA-negative cryosupernatant were sent to 16 participating 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 used as the reference sample as this was the highest dilution of the positive donation that was detected in all assays. In contrast, the results obtained with a commercially available assay, designed for use with single-donation plasma or serum (Roche Amplicor TM HCV test), were not so clear-cut and the assay appeared to be ten-fold less sensitive than the in-house assays.