不同ELISA试剂检测传染病四项弱反应性结果的比较

Comparison of Weak Reactive Results of Four Contagious Diseases Tested by Different ELISA Reagents

目的对比进口和国产几种不同厂家品牌的试剂对HBs Ag、抗-HCV、抗-HIV1/2、抗-TP传染病四项的检测结果,观察分析不同试剂对传染病四项检测弱反应性结果的差异。方法 2017年1—12月无偿献血者血液标本47 586份,应用不同全自动酶免分析仪进行ELISA 2次检测,并对除梅毒以外的167份弱反应性样本利用NAT检测技术进行确认。结果 47 586份样本中HBs Ag弱反应性120份(伯乐71份;万泰49份);抗-HCV弱反应性20份(丽珠5份;万泰15份);抗-HIV1/2弱反应性27份(丽珠5;伯乐22);抗-TP弱反应性98份(丽珠41;万泰57),167份弱反应性样本NAT检测结果 HBV DNA有反应性5份(其中伯乐3;万泰2);HCV RNA有反应性0份;HIV-1 RNA有反应性0份;梅毒螺旋体离体存活时间短不进行核酸检测。结论不同试剂对传染病四项检测弱反应性结果存在差异,尽管存在假反应性结果的可能,但核酸检测发现仍有输血残余风险,单独使用都有可能存在漏检。为了进一步提高临床输血安全水平,2次ELISA检测在血液筛查中仍有实际应用价值。

Objective To compare the test results of several imported and domestic reagents in brands of different factories to the four contagious diseases of HBs Ag, anti-HCV, anti-HIV1/2, anti-TP, and observe and analyze the difference of different reagents to the weak reactive results. Methods 47 586 pieces of blood specimens of voluntary blood donors from January to December 2017 were selected, and different ALISEI was used for second ELISA test, and 167 pieces of weak reactive samples besides the syphilis was defined by NAT test technology. Results Of 47 586 pieces of samples, there were 120 pieces of HBs Ag weak reactive samples（bole 71 pieces, wantai 49 pieces）; 20 pieces of anti-HCV weak reactive samples（lizhu 5 pieces; wantai 15 pieces）; anti-HIV1/2 weak reactive samples（lizhu 5 pieces; bole 22 pieces）; 98 pieces of anti-TP weak reactive samples（lizhu 41 pieces; wantai 57 pieces）, of 167 pieces of weak reactive samples, in terms of NAT test results, there were 5 pieces of samples that the HBV DNA was reactive（bole 3; wantai 2）; 0 piece of sample that the HCV RNA was reactive; and 0 piece of sample that HIV-1 RNA was reactive; and the survival time of treponema pallidum in vitro was short, without nucleic acid test. Conclusion There are differences in the weak reactive results of four contagious diseases tested by different ELISA reagents, even though the false reactivity results are likely to exist, there are still the blood transfusion residual risks in the nucleic acid test, and the simple use may have missed detection. In order to further improve the clinical blood transfusion level, the ELISA test for the second time is of practical application value in the blood screening.