The Study Of Risk Of The Transmitted-transfusion Pathogens In Source Plasma And Recovered Plasma

Background: With blood component widely used, there is lots of surplus recovered plasma(RP) left. On the other hand, the plasma derivatives supply is in shortage because of the lack of source plasma(SP). To solve this problem, a lot of surplus recovered plasma may be used to produce plasma derivatives. However, there was no data on risk of RP used to produce plasma derivatives in order to maintain the blood safety. Evaluation of the transmitted-transfusion pathogens risk in the SP and RP help to maintain the blood safty and provide advice for produce plasma derivatives.Objective: Evaluation of the residual risk of screening regularly virus and of infection risk of non-screening regularly virus in SP and RP, respectively. Comparing the infection risk in this two types of plasma by two statistical methods, and the conclusion can be used to supported for practice which the transfer of recovered plasma to produce plasma derivatives.Material and methods: The samples from SP donors of eight SP donor centers and RP donors of nine blood centers screened reactive for HBs Ag, anti-HCV or anti-HIV from January 1stto December 31 th of 2013 were collected. The demographic data and donation data of all the donors in this period were collected. All the samples screened reactive for anti-HIV, HBs Ag or anti-HCV were confirmed by supplemental testing with neutralization testing for HBs Ag reactive samples, RIBA(recombinant immunoblot assay) for anti-HCV reactive samples and Western blot for anti-HIV reactive samples. In addition, the samples screened reactive for HBs Ag were testedfurther for anti-HBc and HBV DNA. Modify incidence-window model was then used to evaluate the residual risk of screened regularly virus.In addition, 5040 samples from qualified SP donors and 5030 samples from qualified RP donors are collected between July 1st and December 31 th of 2013 from the SP donor centers and RP donor centers described above. The demographic data of these donors were collected also. The commecial kits were used to test for six non-routinely screened pathogens. Poisson distribution model and equivalence test were used to evaluate the residual risk of HBV,HCV and HIV in two types of plasma, and Chi-square test was used to evaluate the infection risk of HAV, B19, WNV, SFTSV, HCMV and HEV in two types of plasma.Results: 475588 SP donations were collected in the study period including 8200 first-time donations and 467388 repeat donations. Among the repeat SP donors, 11, 2 and 3 seroconverters were found for HBV, HCV and HIV, respectively. Through quarantine period policy, the residual risks per million SP donations were 7.699 for HBV, 0.318 for HCV and 0.159 for HIV. Besides quarantine period policy, the residual risks per million SP donations were 7.378 for HBV, 0.281 for HCV and 0.108 for HIV. 106210 RP donations were collected in the study period including 43759 repeat donations. Among the repeat donors, 10, 4 and 3 seroconverters were found for HBV, HCV and HIV, respectively. Four HBs Ag yield cases were found in first-time RP donors and one HBs Ag yield case was found in repeat RP donors. The residual risk per million RP donations were 7.388 for HBV, 0.253 for HCV, and 0.072 for HIV. One B19 DNA positive, one HCMV Ig M reactive and one HEV Ig M reactive samples was found in the 5030 RP samples.The positive rate of nucleic acid test was 1.99/10000, the positive rate of serologic test was 3.98/10000 and the overall positive rate was 5.96/10000. Two B19 DNA positive, two HAV Ig M reactive and two HEV Ig M reactive samples were found in the 5040 SP samples. The positive rate of nucleic acidtest was 3.97/10000, the positive rate of serologic test was 7.94/10000 and the overall positive rate was 11.90/10000. There was no significant difference was found between the SP donations and RP donations.Conclusion: In this study, no significant difference of the residual risk of HIV, HBV and HCV was found for SP donations and RP donations and no significant difference of the prevalence of the six non-routinely screened pathogens was found for the two types of donations. The residual risk of HBV in RP was a little higher than that in SP, but the residual risk of HBV in RP was a little lower than that in SP after storage for one year. Thus, it is believed that the infectious risk of RP is not higher than that of SP and transferring RP for manufacturing will not increase the risk of plasma derivatives.