Application of molecular biology to blood transfusion safety: genomic viral screening

Viral genomic screening (VGS) for HIV-1 and HCV was introduced in France on July 1, 2001, with the aim of enhancing transfusion safety by reducing the residual risk posed by the serological window period preceding the detection of serological markers. The techniques currently available are semi-automated and difficult to apply to large numbers of samples, hence the need to perform viral genome screening on sample pools. Two technologies were selected in France following a national feasibility study. One technology, marketed by Chiron, is based on the principle of isothermal transcription of DNA into RNA (Transcription-Mediated Amplification) and uses pools of 8 samples. A BioMérieux-Roche technology, based on the PCR principle, which combines a nucleic acid extractor (the NucliSens® Extractor from BioMérieux) with an automated amplification-detection system (the Cobas Amplicor® from Roche) and uses pools of 24 samples. These two technologies were organized into workflows performing all operations from the pooling stage through to the reporting of results and their electronic management. Both technologies demonstrate equivalent sensitivity and excellent specificity. After one year of operation, the DGV detected 2 seronegative-RNA-positive donations: 1 for HIV and 1 for HCV out of a total of approximately 2.5 million donations. During the same period, 2 HIV-RNA-positive donations with very low viral loads could not be detected. Furthermore, the implementation of the DGV had very little impact on the availability of labile blood products, particularly that of apheresis platelet concentrates.

Author(s): Assal A, Coste J, Barlet V, Laperche S, Cornillot C, Smilovici W, Pillonel J, Andreu G

Publishing year: 2003

Pages: 217-26

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