血筛用酶联免疫吸附试验与核酸检测互补性探讨和研究

Complementarity of ELISA and nucleic acid amplification test in blood screening

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(ELISA)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45 022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36 806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。

Objective To investigate the complementarity of ELISA and nucleic acid amplification test （NAT） in blood screening, and to improve the security of clinical blood transfusion. Methods A total of 45 022 blood samples from the blood donors without payment from June 2007 to 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 36 806 samples 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.