摘要
目的评估单采血小板样本核酸检测的必要性,以及常规酶免和混样核酸平行检测模式的可行性。方法血液筛查方法为2遍酶免(ELISA)加1遍核酸检测(NAT)。抗-HCV、抗-HIV1/2检测采用万泰和新创公司生产的ELISA试剂盒,HBsAg检测采用科华和新创公司生产的ELISA试剂盒。单采血小板样本采用ELISA与混样核酸平行检测,核酸检测采用罗氏COBASs201系统(6混样)。对ELISA反应性、NAT阴性样本进行确证实验,对ELISA阴性、NAT反应性献血者进行确认及追踪随访。结果共检测单采血小板样本37 496例,检出反应性样本64例,其中ELISA双试剂、NAT检测均为反应性12例,ELISA双试剂反应性、NAT阴性5例;ELISA单试剂、NAT均为反应性4例,ELISA单试剂反应性、NAT阴性20例;ELISA阴性、NAT反应性23例。6例ELISA反应性、NAT阴性样本的确证实验阳性,其中4例为ELISA双试剂反应性,2例为ELISA单试剂反应性。23例ELISA阴性、NAT反应性献血者,经确认22例为隐匿性HBV感染者,1例为HIV"窗口期"感染者。结论 ELISA与核酸检测形成互补,能有效减少单采血小板的输血感染风险;混样核酸与ELISA平行检测模式可行,可最大限度的缩短检测时间。
Objective To evaluate the necessity of apheresis platelet specimens tested by NAT as well as its feasibility of synchronous ELISA and NAT. Methods Blood screening adopts mode of twice ELISA and once NAT. Both Anti-HCV and anti-HIV1/2 were screened by ELISA kits produced by Wantai and Xinchuang, and HBsAg by Kehua and Xinchuang. In addition to ELISA, minipools of 6 NAT was performed to apheresis platelet specimens. Confirmatory tests were done to those positive ELISA but negative NAT specimens. Both confirmatory tests and follow up were complished to negative ELISA but positive NAT specimens and their donors. Results Sixty-four of 37 496 tested apheresis platelet specimens were positive, among them 12 were both double-ELISA and NAT positive;5 were double-ELISA positive but NAT negative,4 were both single ELISA and NAT positive;20 were single ELISA positive but NAT negative;23 were ELISA negative but NAT positive. Six samples with positive ELISA and negative NAT were confirmed to be positive, out of which 4 were double-ELISA positive and 2 were singleELISA positive. In 23 donors of negative ELISA but positive NAT, 22 were confirmed to have latent HBV infection and one was in HBV window period. Conclusions ELISA and NAT are complementary and may effectively reduce the risk of transfusion infection. The simultaneous tests of ELISA and NAT are feasible and may minimize the detection time.
出处
《临床输血与检验》
CAS
2016年第3期217-220,共4页
Journal of Clinical Transfusion and Laboratory Medicine
基金
江苏省卫生厅面上项目(No.H201332)资助
