Which is safer source plasma for manufacturing in China: apheresis plasma or recovered plasma?

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Abstract

BACKGROUND:

In most countries, the plasma for derivative production includes two types of plasma, apheresis plasma (AP) and recovered plasma (RP). However, the plasma recovered from whole blood is not permitted for manufacture in China. Because of the lack of source plasma and the surplus of RP, the Chinese government is considering allowing RP as an equivalent source for the production of plasma derivatives. It is known that human blood can be contaminated by various infectious agents. The objective of the study was to evaluate if infectious risk would increase by enacting this policy.

STUDY DESIGN AND METHODS:

The samples from the two types of blood donors from January 1 to December 31, 2013, were collected. Supplementary testing was conducted and the residual risk (RR) of human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus (HCV) in the two types of blood donors and donations were calculated through the incidence–window period model. Prevalence of the markers of hepatitis E virus, hepatitis A virus, severe fever with thrombocytopenia syndrome bunyavirus, cytomegalovirus, B19, and West Nile virus was calculated.

RESULTS:

No significant difference was found in the RR of the three pathogens in the two types of blood donors. However, after the quarantine period, the RR of HCV and HIV in AP was significantly lower than that in RP. A quarantine period of 2 years will make the infectious risk of RP not significantly different than that of AP.

CONCLUSIONS:

Our data demonstrate that allowing RP to be used for the manufacture of plasma derivatives will not increase its infectious disease risk if coupled with a 2-year inventory hold.

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