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 tran smitted by various plasma-derived medicinal products, the 'Laboratoire fran cais du Fractionnement et des Biotechnologies' (LFB) implemented PCR screen ing of plasma pool samples for B19 DNA as part of the quality control of pl asma source material. Materials and Methods: Plasma pool samples (average o f 46.5 donations) were tested for B19 DNA by PCR and by immunological detec tion of PCR products. The viral DNA content was determined by means of a Ta qMan(TM)-based, quantitative PCR, Results: From plasma corresponding to 2-y ear collections in France, and representing 4.26 million donations from app roximately 1.25 million voluntary unpaid donors, the average frequency of p ositive donations was 1/5,950 and reached 1/1,420 during an epidemic, Level s of B19 DNA in positive pools ranged from <10(2) to 10(11) copies/ml. Conc lusion: A large-scale PCR plasma screening increased the safety of LFB's wi de range of products with respect to B19, a virus particularly resistant to physicochemical inactivation procedures. Copyright (C) 2000 S. Karger AG, Basel.