【摘要】 目的分析并探索合理的单人份核酸筛查方案,为核酸检测后的批放行提供依据。方法对南京地区无偿献血者的63 792份血液标本,采用2种ELISA检测试剂和1种单人份核酸检测试剂平行检测。NAT首先对HIV-1/HCV/HBV 3种病毒进行联合检测,检测结果阴性则判为NAT阴性,阳性则判为NAT阳性,血液报废。NAT初筛阳性标本中与ELISA同为阳性的标本,则直接进行鉴别检测(鉴别病毒种类),ELISA阴性的标本则进行联检2遍复试之后再鉴别。结果 63 792份标本中共NAT初筛(+)标本260例,初筛阳性率0.4%,成功复试和鉴别标本243例,总鉴别阳性率仅为64.2%(156/243)。其中ELISA(+)标本的鉴别阳性率为89.0%(121/136),ELISA(-)标本的鉴别阳性率为32.7%(35/136),复试阳性率为44%(47/107)。NAT初筛S/CO的均值与复试、鉴别结果具有明显相关性,初筛S/CO≤5对复试(--)且鉴别(-)结果有较强的指示作用。结论本中心目前的核酸筛查方案能够最大程度地减少病毒漏检现象,降低输血残余风险,保障临床供血安全。更多还原

【Abstract】 Objective To analyze and explore a reasonable ID-NAT screening program,and to provide an evidence based foundation for the release of blood products after NAT. Methods 63 792 blood samples of unpaid blood donors in Nanjing area were tested with two types of ELISA reagents in parallel and one type of ID-NAT reagent. Samples were first screened for HIV-1 / HCV / HBV nucleic acid with Ultrio assays. Non-reactive results were determined as negative(-) for NAT,while reactive results were determined as positive( +) for NAT. Resultant blood products were discarded. The positive samples tested by both NAT and ELISA were directly tested in discriminatory assays( which differentiate the types of virus). Samples that were tested positive by NAT but negative by ELISA underwent two more rounds of testing with Ultrio assays,followed by discriminatory assays. Results 260 out of 63 792 samples,or 0. 4%,were determined NAT( +) in the first screening,among which,243 samples were successfully retested and underwent discriminatory assays. The positive rate in the discriminatory assays was 64. 2%( 156 /243). The discriminatory positive rate of ELISA( +) samples was 89%(121 /136),while in ELISA(-) samples,the rate was 32. 7%(35 /136). The positive rate after retesting was 44%(47 /107). There was a notable positive correlation between S / CO mean values from the results of first NAT screening and results of the retest and discriminatory assays. The result S / CO ≤ 5 was likely to provide basis for the results of the retest(--)and discriminatory assays(-). Conclusion The current NAT screening program of our center could optimize the reduction in the incidence of missed detection of virus in blood,decrease the residual risks in transfusion,and guarantee the safety of clinical blood use.更多还原