献浆人群中富含高滴度巨细胞病毒中和抗体者的分布研究

Study on thedistribution of high titer neutralizing antibody against human cytomegalovirus in plasma donors

目的了解普通献浆人群中人巨细胞病毒(HCMV)高滴度中和抗体献浆者的分布情况。方法2014年4月,采用微量细胞病变法,检测血浆920人(份),了解中和抗-HCMV分布情况,对混浆进一步检测,确定筛选血浆的阈值;2019年10月~2020年5月,以筛选阈值为高滴度,筛查山东省域内11个单采血浆站的普通献浆人群40078人(份)血浆标本的中和抗-HCMV,应用SPSS 26和Minitab19软件分析其中富含高滴度的中和抗-HCMV者的比例与在献浆者人群中的分布。结果920人(份)血浆中73.26%献浆者中和滴度<1∶15,0.43%献浆者中和滴度≥1∶60,8.69%献浆者中和滴度≥1∶30,检测混浆中和滴度,确定1∶30为原料血浆筛选高滴度;本组山东地区高滴度中和抗-HCMV筛出率9.06%(3633/40078);各浆站高滴度中和抗-HCMV献浆者在其献奖人群中的比例在4.95%~13.03%(9.06±2.07)%;不同性别高滴度中和抗-HCMV献浆者占其各自性别献奖者的比例:女性为15.67%(2185/13951)、男性为5.54%(1448/26127)(P<0.05)。结论高滴度中和抗-HCMV献浆者在山东地区献浆者人群中呈一定的分布(比例),可作为富含中和抗-HCMV原料血浆稳定的来源,保障抗-HCMV免疫球蛋白制品的生产。

Objective To investigate the distribution of plasma donors with high titer neutralizing antibodies against human cytomegalovirus(HCMV)in the general plasma donor population.Methods 920 plasma samples of Taibang were tested in April 2014 to investigate the distribution of anti-HCMV neutralizing antibodies.After further testing of mixed plasma,the threshold for screening plasma was determined.From October 2019 to May 2020,neutralizing anti-HCMV in 40078 plasma samples from 11 plasma stations in Shandong province were screened by the microcytopathic method(modified high-flux neutralization test method).The proportion of neutralizing anti-HCMV enriched in high titer and the distribution in the donor population were analyzed by SPSS 26 and Minitab19 analysis software.Results Among 920 samples,73.26%,0.43%,and 8.69%of them had neutralization titer<1∶15,≥1∶60 and≥1∶30,respectively.The neutralization titer of mixed plasma was detected,and 1∶30 was determined as the high titer.The yielding rate of high titer neutralizing anti-HCMV in Shandong was 9.06%(3633/40078).The proportion of plasma donors with high-titer neutralizing anti-HCMV in the donation population from plasma stations was 4.95%~13.03%(9.06±2.07)%.The proportion of plasma donors with high-titer neutralizing anti-HCMV by gender was 15.67%(2185/13951)in women and 5.54%(1448/26127)in men(P<0.05).Conclusion There was a certain proportion of plasma donors wiht high titer neutralizing anti-HCMV in the population of plasma donors in Shandong,and they can constantly serve neutralizing anti-HCMV to ensure the production of anti-HCMV immunoglobulin preparations.