One manufacturer's approach to using nucleic acid testing for enhanced plasma-product safety

Abstract

Source plasma must contain the lowest possible pathogen bioburden so as to minimize the stress placed on subsequent viral reduction steps. Differences exist between European and US criteria for developing assays used to detect these viral pathogens. The approach used by 1 plasma-product manufacturer is described here. By adding polymerase chain reaction (PCR) detection techniques for various viral pathogens (including human immunodeficiency virus-1, hepatitis C virus, and hepatitis B virus) to the plasma screening process, this manufacturer maximizes the use of cutting-edge technology for plasma product safety while satisfying both European and US criteria and requirements for this process. The protocol begins with maxipool testing and eventually identifies any specific donor plasma that might be positive in the contributing minipools. The goal is to identify reactive donors for possible periodic monitoring and to use only nonreactive donations to continue producing a particular plasma product. Controversy surrounding the use of PCR to screen emerging organisms of questionable pathogenicity or known organisms that are of minimal pathogenicity for most of the population is also discussed, and possible solutions to this debate are provided.