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In 1994 the European Plasma Fractionation Association (EPFA) in conjunction with NIBSC held a workshop to discuss potential applications of NAT such as PCR in the detection of blood borne viruses in blood donation screening, to the production of “clean” plasma derived products. The meeting concluded that:
PCR does have a role to play in confirmation of blood borne virus presence.
Improvements are being made in technique therefore detection of false positive and negatives are reducing.
Commercial companies are responding to these changing needs and new assays are being developed.
There is a need for standardization in this area.
The forum in which this group first met was not intended to focus entirely on standardisation. However it was recognized that the future importance of PCR and the potential problems already discussed with the group warranted the formation of a group dedicated to standardization of NAT for the detection of blood borne viruses.
The 1st meeting of the International Working Group on the Standardisation of Genomic Amplification Techniques (SoGAT) for the virological safety testing of Plasma and Blood derived Products took place in April 1995. The group met to discuss standardisation techniques for blood viruses such as HCV, HBV, B19 as well as HIV. The rapid development of commercial assays for NAT and the appreciation of the scope of this new technology by many diagnostic and research laboratories, led to a decision that there was a need for reference materials for blood borne viruses.
Since 1994 the group have been paramount in the establishment of International Standards for HIV-1 RNA, HCV RNA, HBV DNA and B19 as well as formulating various concentrations of working reagents. Whilst there has been many achievements the group remain essential to drive the generation of replacement standards, agree on the need and formulation of new standards and to provide expertise, concepts and strategies to the users of the products.
Using the experience and knowledge gained by the SoGAT group focusing on blood virology, a new SoGAT group has been formed to address the area of clinical virology, which remains largely unstandardised.
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