Large-scale screening for human parvovirus B19 DNA by PCR: Application to the quality control of plasma for fractionation

Background and Objectives: Because human parvovirus B19 (B19) has been transmitted by various plasma-derived medicinal products, the 'Laboratoire francais du Fractionnement et des Biotechnologies' (LFB) implemented PCR screening of plasma pool samples for B19 DNA as part of the quality control of plasma source material. Materials and Methods: Plasma pool samples (average of 46.5 donations) were tested for B19 DNA by PCR and by immunological detection of PCR products. The viral DNA content was determined by means of a TaqMan(TM)-based, quantitative PCR, Results: From plasma corresponding to 2-year collections in France, and representing 4.26 million donations from approximately 1.25 million voluntary unpaid donors, the average frequency of positive donations was 1/5,950 and reached 1/1,420 during an epidemic, Levels of B19 DNA in positive pools ranged from <10(2) to 10(11) copies/ml. Conclusion: A large-scale PCR plasma screening increased the safety of LFB's wide range of products with respect to B19, a virus particularly resistant to physicochemical inactivation procedures. Copyright (C) 2000 S. Karger AG, Basel.