[Application of molecular biology to blood transfusion safety: the nucleic acid testing]

Abstract

Nucleic Acid Testing (NAT) for HIV-1 and HCV has been introduced in France and became mandatory for all homologous blood donations since July 1st 2001 in addition to serology screening. Previously, a feasibility study led to the selection of 2 technologies : a TMA based assay (Chiron) uses the Procleix HIV-/HCV assay on pools of 8 samples and a PCR based assay from BioMérieux-Roche which is a combination of an RNA extraction system (NucliSens, BioMérieux) with a fully automated system for nucleic acid amplification and detection (Cobas Amplicor, Roche). This system uses the Cobas Ampliscreen HCV test v.2.0 and the The Cobas Ampliscreen HIV test v1.5, on 24 sample pools. Pooling was required because single-donation testing is not yet feasible, as a result of the limitations in automation available for all current NAT technologies. The two technologies were easily implemented and showed nearly the same detection limit for HCV RNA and HIV-1 RNA. During a one-year period, from July 1st 2001 to June 30, 2002, out of the 2.5 million donations tested, the NAT yield resulted in one HIV-1 RNA positive-antibody negative donation and one HCV RNA positive-antibody negative donation. Two HIV NAT positive-antibody negative donations were missed by minipool NAT because a very low viral load. Moreover, the NAT implementation did not impact on blood component availability, including platelet concentrates.