Collaborative study for the calibration of a new Italian HCV RNA reference preparation against the international standard.

Abstract

We organised a collaborative study to calibrate a new Italian reference preparation for HCV RNA, the ISS 0102 reagent, to be used for plasma pools testing. This preparation will replace the previous one, the ISS 0498 reagent, as we are running short of it. The ISS 0102 reagent was obtained by appropriately diluting an HCV RNA-positive donation. Every participant in the collaborative study received four coded panels, each consisting of 5 semi-logarithmic dilutions of the international standard, 5 semi-logarithmic dilutions of the ISS 0102, and 2 samples of a negative plasma pool. Based on the results provided by the 22 participating laboratories, an HCV RNA concentration of 4500 IU/ml was assigned to the reference material. This preparation is available free of charge to any laboratory upon request.