Background

The English National Blood Service (NBS) established a nucleic acid amplification technology (NAT) Steering Group in 1996 to produce a strategy in anticipation of a regulatory requirement for hepatitis C virus (HCV) RNA testing of manufacturing scale plasma fractionation pools. This subject was first raised in 1995 by the Committee for Proprietary Medicinal Products (CPMP) and the requirement was published in CPMP/BWP/390/971 (CPMP, 1998). The ‘start pool’ of plasma for fractionation had to be tested by NAT and shown to be negative for HCV RNA.

The implementation date for HCV NAT was 1 July 1999 for plasma fractionators. (Please refer to Chapter 20.) Hepatitis C virus RNA pre-testing of sub-pools (i.e. testing before pooling of all plasma takes place) was implemented in the National Blood Service to avoid the loss of large-scale plasma pools for fractionation as a result of contamination by HCV RNA. In addition, it was also important to prevent transmission of HCV via any other blood components from donors identified to be HCV RNA positive through testing of plasma pools for fractionation (please refer to Chapters 13 and 14). This inevitably led the blood services to introduce the requirement for real-time NAT to allow timely withdrawal of all labile blood components identified as HCV RNA positive. Nucleic acid testing for all labile components was introduced as soon as practicable and was completed by the NBS in July 2000.