Standardisation of Nucleic Acid Amplification Techniques (NAT) for the Detection of Viral Contamination of Blood and Blood Products

摘要

The standardisation of NAT assays (both sensitivity ands specificity) can be achieved by the use of commonly accepted standards in all assay runs. Based on the results of collaborative studies organised by NIBSC, working reagents for NAT assays for HCV RNA, HAV RNA, HIV RNA and parvovirus B19 DNA have been established. Data on the performance of the HCV working reagent over approximately two years have indicated an improvement in the sensitivity of assays, both in-house and commercial. A WHO International standard for HCV RNA NAT assays was established in 1997 based on the results of a collaborative study. This standard is a lyophilised preparation of a genotype 1 isolate diluted in HCV-negative cryosupernatant. The HCV RNA content is expressed in International Units (IU) and each vial of the standard contains 50 000 IU. Preliminary work has indicated that 1 IU is approximately equivalent to 5 genome equivalents.