献血者血袋辫血样本使用国产ELISA试剂检测HBsAg,抗-HCV,HIV Ag/Ab和抗-TP项目的可靠性研究

目的 比较血袋辫血与试管样本在国产ELISA初筛反应性献血者复试结果的差异及漏检情况,评价辫血复试的可靠性。方法 收集血站2014年7月1日～2018月11月30日HBsAg,抗-HCV,HIV Ag/Ab和抗-TP项目初筛反应性样本的复试结果,按不同试剂厂家进行分组,分析辫血与试管样本检测结果(S/CO值)的差异和漏检情况。结果 不同试剂间辫血与试管检测结果的总体差值范围是-0.144～0.514(中位数),其中辫血在抗-HCV万泰组的S/CO值大于试管样本(Z=4.806,P=0.000),在其余试剂组的S/CO值均小于试管样本(Z=2.215～13.332,均P<0.05); S/CO值为0.9～2.0的弱阳性样本中,辫血的检测值低于试管的范围是0.016～0.651(中位数),相对于试管的漏检率为7.41%～60.67%,其中偏差最大的是HIV Ag/Ab万泰组,检测值偏差的四分位数和漏检率分别为0.651(0.206,0.886)和60.67%; 辫血在抗-TP新创试剂检测中,设置灰区(90% cutoff)后的漏检率33.71%低于不设灰区漏检率48.31%(χ2=3.925,P=0.048),但其它9种试剂组设置灰区不能降低辫血的漏检率(χ2=0.000～3.065,均P>0.05)。结论 血袋辫血进行ELISA的检测值普遍低于试管样本,在不同试剂或项目的检测结果偏差和漏检程度不同; 血站实验室对弱阳性样本使用辫血复试需谨慎对待,应根据实际情况调整血液复试流程或灰区设置。

Study on the Reliability of Detecting HBsAg,Anti-HCV,HIV Ag/Ab and Anti-TP in Blood Braided Samples from Blood Donors with Domestic ELISA Reagents

Objective To compare the differences and leak detection between the retest results of the blood braided samples and the test-tube samples for reactive blood donors screened by domestic ELISA,and evaluate the reliability of the blood braided samples for retests.Methods The retest results of HBsAg,anti-HCV,HIV Ag/Ab and anti-TP items screening samples which were reactive in first screening were collected from July 1,2016 to November 30,2014,and were grouped by different reagent manufacturers.The difference and leak detection between the blood braided and the test-tubesamples retest results(S/CO value)were analyzed.Results The range of overall difference between the blood braided and the test-tubesamples results was between -0.144 and 0.514(median).The S/CO value of bloodbraided samples in anti-HCV Wantai group was greater than that of test-tube samples(Z=4.806,P=0.000).In the other reagent groups,the S/CO value wassmaller than the test-tube sample(Z=2.215～13.332,all P<0.05).Inthe weak positive sample with S/CO value of 0.9～2.0,the result values of blood braided samples were lower than the test-tube,and the range was 0.016 to0.651(median position).The leak detection rate relative to the test tube was7.41% to 60.67%,and the maximum deviation was HIV Ag/Ab Wantai group.The quartile and leak detection rate of the result value deviation was 0.651(0.206,0.886)and 60.67%.For the blood braided samples,in the detection of anti-TP Xinchuang reagent,the leak detection rate after setting the gray area(90% cutoff)was 33.71% lower than that of the no setting gray area 48.31%(χ2=3.925,P=0.048),but for the other 9 reagents,the gray area could not reduce the leak detection rate of the blood braided samples(χ²=0.000～3.065,all P>0.05).Conclusion The result values of ELISA in the blood braided samples were generally lower than that in test-tube samples.The deviation of test results and the degree of leak detection in differentreagents or items were different.The blood center laboratory should be cautious when using blood braided samples for retest weakly positive samples.Blood retest process or gray area setting should be adjusted according to the actual situation.