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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 effectiveness of raw blood quarantine management and the risk differences of different types of unqualified blood plasma in quarantine period. Methods The total number of HBsAg, anti-HCV and anti-HIV in 3 257 272 raw blood samples from 2011 to 2014 were detected by ELISA. The unqualified plasma from the quarantine period of the unqualified plasma and its plasma donors was rejected for 90 days No follow-up testing information within 1 year Quarantine period without follow-up information Disqualified plasma treatment, statistical quarantine period plasma unqualified rate and HBs Ag, anti-HCV, anti-HIV test Positive tracking and quarantine period without follow-up test information Not Qualified plasma ratio; 2013 failed quarantine plasma made NAT test, compared with different types of quarantine failed plasma risk. Results The unqualified rate was 0.025% (801/3 257 272) during the inspection period from 2011 to 2014, with a detection rate of 0.002% (76/3 257 272) (P <0.01). In different types of unqualified quarantine period, HBs The unqualified plasma of quarantine period for Ag and anti-HIV test were 36.95% (296/801) and 35.21% (282/801), respectively. The positive rate of negative plasma in 2013-negative quarantine period was 18.62% (46/247), of which HBV, HCV and HIV accounted for 34.29% (36/105), 6.67% (2/30) and 9.76% (8/82) of the unqualified quarantine plasma in the same period respectively, with no follow-up information The quarantine period of failed plasma HBV / HCV / HIV NAT test were negative. Conclusion The quarantine period management system can eliminate the missed samples during the window period and further improve the safety of the raw material plasma. In the quarantine period without follow-up information, the risk of unqualified plasma is much lower than that of the unqualified plasma during the quarantine period, The risk of HBV is the largest.