机构地区:[1]中国医学科学院北京协和医学院输血研究所,四川成都610052 [2]四川省血液安全血液代用品国际科技合作基地 [3]Research Triangle Rark, United States [4]绵阳市红十字中心血站 [5]乌鲁木齐血液中心 [6]广西壮族自治区血液中心 [7]洛阳市中心血站 [8]重庆市血液中心 [9]约翰霍普金斯医院病理学系 [10]美国斯坦福大学病理系
出 处:《中国输血杂志》2018年第9期982-985,共4页Chinese Journal of Blood Transfusion
基 金:美国NHLBI献血者逆转录病毒流行病学研究三期国际合作项目(REDS-Ⅲ,X101222002)
摘 要:目的了解我国献血者丙型肝炎病毒(HCV)的初筛阳性率和确证阳性率。方法采用2种不同ELA试剂对2013年6月-2016年12月我国5家血液中心/中心血站献血者血液标本进行ALT、HBsAg、抗-HCV、抗-HIV、抗-TP进行常规筛查,抗-HCV单试剂或双试剂筛查阳性标本进一步采用MP HCV Blot 3. 0进行确证检测。分别估算首次献血者的HCV流行率及重复献血者的HCV发病率,并采用χ~2检验比较不同人群体、不同献血类型之间HCV确证阳性率。结果在1 276 544人次献血样本中,有3 855 (0. 30%)为抗-HCV ELISA初筛反应性,其中只有30. 18%(904/2 995,)确证为抗-HCV阳性。本次研究中,首次献血者总计648607人次,其中1080份样本确证为抗-HCV阳性,即首次献血者HCV流行率为166. 56 (156. 04—177. 08)/100 000人次,年龄、受教育水平、职业均与HCV确证阳性率相关。重复献血者总计627 937人次,其中126份样本确证为抗-HCV阳性,即重复献血者HCV发病率为13. 04(9. 55—17. 81)/100 000人次,其中重复献血者抗-HCV确证阳性率明显高于单采血小板献血者(0. 02%vs0. 01%)。结论本研究表明我国献血者HCV仍处于较高水平流行状态。尽管现在NAT已成为我国血液检测的常规检测项,但仍需持续有效地对我国输血HCV传播风险进行监测和控制。同时,新的规范中规定可采用1种或2种EIA进行筛查,本意是为了提高检测敏感性,但本研究中EIA筛查阳性样本如此低的确证阳性率提示其特异性差,可能会造成许多合格的献血者丢失。因此,优化献血者HCV筛查策略将有助于防止血液浪费。Objective To evaluate the current screening reactive rates and confirmatory positive rates of HCV among Chinese blood donors. Methods Whole blood and apheresis platelet donations from five Chinese blood centers collected during June 2013 to December 2016 were screened by two different ELISA assays for alanine aminotransferase,anti-HIV 1/2,HBsAg,anti-HCV and syphilis. The samples reactive by one or both anti-HCV ELISA tests( "screen reactive") were further confirmed by MP HCV Blot 3. 0. HCV prevalence among the first-time and the incidence among the repeated donations were separately evaluated. Chi-square statistics were used to compare the HCV confirmatory positive rates between different demographic groups and by donation characteristics. Results Among 1,276,544 donations,3855( 0. 30%) were screen reactive for anti-HCV,30. 18% of which( 904/2995) were confirmed reactive( CT +). Among 648,607 the first-time donations,1080 were CT+,yielding a prevalence of 166. 56 per 100,000( 95% confidence interval [CI],156. 04—177. 08). Age,education,and occupation were all important factors associated with HCV confirmatory status among the first-time donors. Among the 627,937 donations from repeated donors,only 126( 0. 02%) were CT +. Higher CT + rate was found among the whole blood donation cases than the apheresis platelet donations( 0. 02% vs. 0. 01%). Conclusion The HCV infection rate is still high among Chinese blood donors. Despite the implementation of NAT in routine donation screening,more efforts are required to monitor and control the risk of transfusion transmitted HCV transfusion in China. Meanwhile,although the policy to defer all donors with one( or both) ELISA screen reactive result was meant to enhance screening sensitivity,the low confirmatory rate in ELISA-reactive donations suggests that many qualified donors were screened out due to the poor specificity. Improvements of HCV donor screening procedures can help to prevent unnecessary donor loss.
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