血筛用酶联免疫吸附试验与核酸检测互补性探讨和研究

目的为了提高临床输血的安全性，探讨核酸检测（NAT）与酶联免疫吸附试验（EuSA）技术在血液筛查工作中的互补特性。方法对2007年6月至2008年3月采集的无偿献血者标本共计45022例用ELISA血清学检测方法对血液传染性指标HBsAg、抗-HCV、抗-HIV、梅毒螺旋体、丙氨酸氨基转移酶（ALT）进行检测，各项指标均正常的标本用NAT技术检测，以研究2种检测方法的互补性。结果45，022例标本中血清学检测及ALT不合格人数共计803例，不合格率为1．98％。对各项检测指标合格的36806例标本进行核酸检测，结果HBV-DNA呈阳性3例。HBV-RNA、HIV-RNA均未检出。结论NAT与ELISA的血液筛查检测互补作用主要体现在3个方面：1）病理生理过程互补，检测窗口期的长短主要由检测对象的生理属性来决定，而非检测方法缺陷。2）检测方法学互补，由于检测方法学的不同使得NAT技术的检测灵敏度明显高于ELISA血清学检测方法。3）影响各自实验的错误发生各不相同。

Complementarity of ELISA and nucleic acid amplification test in blood screening

Objective To investigate the complementarity of ELISA and nucleic acid amplification test(NAT)in blood screening,and to improve the security of clinieal blood transfusion.Methods A total of 45 022 blood samples from the blood donors without payment from June 2007to March 2008 were enrolled in the study.ELISA was applied to determining HBsAg,anti-HCV,anti-HIV,anti-treponema pallidum(anti-TP)and ALT,and then the normal samples for the above parameters(serologically negative for HBsAg.anti-HCV, anti-HIV,anti-TP and ALT)were detected with NAT.The complementarity of ELISA and NAT was analyzed.Results Totally 803 cases(1.98%)were unqualified(serologically positive)out of the 45 022 blood samples.The qualified 36 806samples were further detected with NAT.The results showed 3 cases were HBV-DNA positive,but none was positive for HBV-RNA and HIV-RNA.Conclusion The complementary action of ELISA and NAT is due to different window phase for detected subjects,technological difference and different influencing factors.