摘要
目的分析原料血浆检疫期管理的有效性和不同类型检疫期不合格血浆的风险差异。方法 2011-2014年采用ELISA法合计检测3 257 272份原料血浆的HBs Ag、抗-HCV、抗-HIV,剔除检测不合格血浆及其献血浆者的检疫期不合格血浆,供血浆90 d后1年内无后续检测信息按无后续信息的检疫期不合格血浆处置,统计检疫期血浆的不合格率和HBs Ag、抗-HCV、抗-HIV检测阳性追踪的以及无后续检测信息的检疫期不合格血浆比例;对2013年检疫期不合格血浆做NAT检测,比较不同类型检疫期不合格血浆风险。结果本组2011-2014年检疫期不合格率0.025%(801/3 257 272),检测不合格率0.002%(76/3 257 272)(P<0.01);不同类型检疫期不合格血浆中HBs Ag和抗-HIV检测不合格追踪的检疫期不合格血浆分别占36.95%(296/801)、35.21%(282/801);2013年ELISA阴性的检疫期不合格血浆的NAT阳性率为18.62%(46/247),其中HBV、HCV、HIV分别占同类型检疫期不合格血浆的34.29%(36/105)、6.67%(2/30)、9.76%(8/82),无后续信息产生的检疫期不合格血浆的HBV/HCV/HIV NAT检测均为阴性。结论检疫期管理制度能剔除窗口期漏检血浆,进一步提高原料血浆的安全性;无后续信息的检疫期不合格血浆的风险远低于检测不合格追踪的检疫期不合格血浆,后者中又以HBV风险最大。
Objective To analyze the efficacy of quarantinemanagement of source plasma,as well as the risk of different types of rejected plasma in quarantine period. Methods A total of 3 257 272 donations,collected in 2011- 2014,were tested by ELISA kits for HBs Ag,HCV antibody,HIV antibody,respectively. Rejected donations that did not pass testing and the corresponding rejected donations in thequarantine period were eliminated. If there was no further testing information after90 days and within 1 year since the last donation,the donation was defined as rejected donation with no further information. The ratio of rejected donations and the ratio of different types of rejected donations were calculated. NAT testing was performed on rejected donations in quarantine period in 2013. The risks of different types of rejected donations were compared. Results A total of 801 rejected donations were eliminated in 2011- 2014,accounting for 0. 025% o（ 801 /3 257 272） f the total plasma. The ratio of rejected donations ofquarantine period was much higher than that of retesting. Among the rejected plasma of different types in thequarantine period,the ratios of rejected plasma for HBs Ag and HIV antibody were relatively higher,accounting for 36. 95%（ 296 / 801） and 35. 21%（ 282 / 801）,respectively. NAT testing was performed on 247 rejected donations duringquarantine periodin 2013 which were negative by ELISA. 18. 62%（ 46 /247） donations were NAT positive,among them HBV,HCV,HIV NAT positive donations were 36,2,and 8 bags,accounting for 34. 29%（ 36 /105）,6. 67%（ 2 /30）,and 9. 76%（ 8 /82）,respectively. Rejected donations with no further information were all negative for HBV / HCV /HIV NAT. Conclusion Quarantinemanagement can eliminatewindow period plasma,and then canfurther enhance the safety of source plasma. According to the study,the risk of rejected donations with no further information is much lower than that of rejected donations that failed quarantine testing. The risk of HBV is the highest in rejected donat
出处
《中国输血杂志》
CAS
北大核心
2015年第12期1478-1481,共4页
Chinese Journal of Blood Transfusion
