Viral safety of recovered plasma for contract fractionation; an Iranian experience, 2006–2015

Abstract

Objective The current study analysed the viral safety among Iranian blood donors. Background Plasma products demand is increasing in the world. With contract plasma fractionation, the plasma wastage decreases and the access of patients to plasma‐derived medicines (PDM) improves. Study and Design Method Screening results including hepatitis B surface antigen (HBsAg), anti‐hepatitis C virus (HCV), and human immunodeficiency virus (HIV) Ag/Ab of 19 054 036 donations from 2006 to 2015 were analysed. The plasma for fractionation was tested for HBV DNA, HCV RNA, HIV RNA, HAV RNA, and Parvovirus B19 DNA by fractionators. New samples were collected from the positive donors and retested. The prevalence of serological and nucleic acid testing (NAT) markers per 105 donations, 95% confidential interval (CI), and p‐values were calculated. Results The prevalence of markers was as follows: 250/105 donations for HBsAg from 516 in 2006 to 116/105 donations in 2015; 74/105 donations for HCV, decreasing from 127 to 41/105 and 3.6/105 for HIV during current study. During 10 years, 5 713 641 units of recovered plasma were shipped for contract fractionation to produce PDM; 0.26/105 donations for HBV DNA and 0.14/105 for HCV RNA were reported positive. The results of five retested samples for HBV and one sample for HCV were negative. Conclusion The prevalence of HBV, HCV, and HIV in blood donations was extremely low. Thanks to the availability, high quality and safety of recovered plasma as a result of the improvements in the quality system at IBTO, this plasma could be used for the production of PDMPs.