DEVELOPMENT OF VIRUS SAFETY CONTROL ALGORITHM FOR THE MANUFACTURE OF DONOR PLASMA PRODUCTS

作者：Zubkova N V^*; Kazyanin A V; Nikolaeva A M; Lapteva L K; Silin E V

来源：Gematologiya i Transfuziologiya, 2012, 57(1): 10-13.

• donor plasma
• plasma minipools
• admission control
• enzyme immunoassay
• polymerase chain reaction
• contamination risk

Based on the data on the distribution of serological and molecular genetic markers of hepatitis B viruses and hepatitis C viruses and HIV in infected donors and the probability of infected samples delivery to production shops, the authors have evaluated the risk of viral contamination of the donor plasma for drug manufacture. The impact of the admission control algorithm for the probability and level of virus charge of the plasma production pools has been evaluated. Admission control in the form of parallel testing of plasma minipools of 24 +/- 4 donations by enzyme immunoassay and polymerase chain reaction using standard commercial kits effectively detects the infected samples, meets the WHO requirements, and is recommended for testing the plasma samples intended for technological processing. More rigid testing is recommended for plasma samples intended for transfusions: more sensitive tests should be used, particularly for detection of hepatitis B virus DNA, and the minipools for testing should be minimized to presumably individual donations.

• 出版日期2012-2