INTRODUCTION OF NUCLEIC-ACID AMPLIFICATION TESTING OF PLASMA POOLS - IMPLICATIONS FOR AN INTEGRATED BLOOD SERVICE

Most fractionated plasma products are manufactured by processes that i nclude at least one process step capable of inactivating 6 or more log s of HCV. The requirement to test fractionation pools for HCV RNA is b eing developed on the back of experience of HCV transmission by a prod uct that did not include such an inactivation step. Application of nuc leic acid amplification testing (NAT) will contribute little to the sa fety of fractionated products; in time it will provide an opportunity to measurably enhance the safety of cellular products. The National Bl ood Service (NBS) will implement NAT in two distinct phases. In the fi rst phase NAT will be applied to minipools of about 500 donations in o rder to release plasma for fractionation to allow compliance with such regulatory requirements as are defined for fractionation pools. In a second phase NBS will look to secure the more obvious benefits of appl ication of NAT to increase the assurance of safety of cellular product s, probably once again by minipool testing. Testing is likely to be ex tended to genomes other than HCV as experience develops.