摘要
目的初步了解化学发光法用于无偿献血血液筛查中的效果。方法采用2种不同的ELISA试剂和1种化学发光试剂(CLIA试剂)对卫生部临检中心提供的28盒(2 442个)血清盘标本和3 034个正常献血者标本进行HBsAg、抗-HCV、HIV抗原/抗体和抗-TP4项检测,在检测献血者标本时,除酶免双试剂阳性外,其余标本还需进行HBV/HCV/HIV病毒核酸检测,任意1项检测有反应性的标本均送卫生部临检中心进行确认。结果在检测28盒血清盘时,计算各试剂的灵敏度和特异性,利用受试者工作特征曲线(ROC)计算曲线下面积(AUC),并采用Z值检验进行比较,其中HBsAg项目的CLIA试剂与2种ELISA试剂检测的AUC值分别为0.999、0.958和0.961,差异有统计学意义(Z=3.40、4.19,P均<0.05),HIV抗原/抗体项目的CLIA试剂与ELISA试剂1检测的差异无统计学意义(P>0.05),CLIA试剂与ELISA试剂2检测的AUC值分别为0.992和0.958,差异有统计学意义(Z=2.53,P<0.05),其他2个项目的3种试剂检测的差异无统计学意义(P均>0.05);在检测3 034份献血者标本时,HIV抗原/抗体项目的CLIA试剂与2种ELISA试剂的筛查阳性率分别为0.40%、0.09%和0.09%,差异有统计学意义(χ~2=8.968,P<0.05),而其他3个项目的CLIA试剂与2种ELISA试剂的筛查阳性率差异无统计学意义(P均>0.05);32份(4份HBsAg、8份抗-HCV、11份HIV抗原/抗体和9份抗-TP)检测结果不一致的献血者标本经卫生部临检中心确认全部为阴性。结论化学发光试剂的HBsAg检测优于ELISA试剂,但其献血者标本HIV抗原/抗体的筛查阳性率明显偏高,所以化学发光检测用于血液筛查可能还需进行个别项目参数的优化,以免不必要的血液浪费。
Objective To preliminarily understand the effect of chemiluminescence in voluntary blood donation screening.Methods Two different ELISA reagents(reagent 1 and reagent 2)and one chemiluminescent reagent(CLIA reagent)were used to detect HBsAg,anti-HCV,HIV antigen/antibody and anti-TP in 3 034 normal blood donors and 28 boxes of serum discs(including 2 442 discs)provided by National Center for Clinical Laboratories.Blood donor samples,except for those positive with dual ELISA reagents,further needed to be tested for HBV,HCV and HIV nucleic acid.Any of the reactive samples were sent to National Center for Clinical Laboratories for confirmation.Results The sensitivity and specificity of each reagent were calculated when 28 boxes of serum dishes were detected.The area under the curve(AUC)was calculated by using the receiver operating characteristic curve(ROC),and compared by Z value test.The AUC values of CLIA reagent and two ELISA reagents in HBsAg were 0.999,0.958 and 0.961,respectively.The difference was statistically significant(Z=3.40,4.19,P<0.05).No significant difference between the results of the HIV Ag/Ab tested by CLIA reagent and the ELISA reagent 1 was observed(Z=0.98,P>0.05);the AUC values of CLIA reagent and ELISA reagent 2 were 0.992 and 0.958,respectively,with statistically significant difference(Z=2.53,P<0.05).There was no significant difference in the detection results of three reagents in the other two items(i.e.anti-HCV and anti-TP)(P>0.05).In the detection of 3 034 blood donor samples,the positive rates of CLIA reagent and two ELISA reagents in HIVAg/Ab project were 0.40%,0.09%and 0.09%,respectively,and the difference was statistically significant(χ~2=8.968,P<0.05),while there was no significant difference in the positive rate of the CLIA reagent and the two ELISA reagents in the other three items(i.e.HBsAg,anti-HCV and anti-TP)(χ~2=1.146,2.055,3.618,P>0.05).Thirty-two blood donors samples(4 of HBsAg,8 of anti-HCV,11 of HIV Ag/Ab and 9 of anti-TP)with inconsistent results were confirmed to be neg
作者
许友山
金建怀
李林
夏卫
XU Youshan;JIN Jianhuai;LI Lin;XIA Wei(Wuxi Red Red Cross Blood Center,Wuxi 214021,China)
出处
《中国输血杂志》
CAS
2019年第5期448-452,共5页
Chinese Journal of Blood Transfusion
