ORTHO抗-HCV酶联免疫试剂2种孵育试验程序在血液筛查中的比较研究  

Comparison of the two test procedures of ORTHO HCV 3.0 ELISA test system for blood donor screening

作　　者：邱艳[1] 查祎[1] 杨海平[1] 孙莉[1] 郭瑾[1] 许志远[1] 修冰水[2] 

机构地区：[1]北京红十字血液中心,北京100088 [2]军事医学科学院基础医学研究所

出　　处：《中国输血杂志》2012年第8期734-737,共4页Chinese Journal of Blood Transfusion

基　　金：国家高新技术研究发展计划(863计划)(2008AA02Z434);北京市自然科学基金(7082048);国家留学基金(2007106992)

摘　　要：目的确定1种3代抗-HCV酶免试剂(ORTHO HCV 3.0 ELISA试剂)2种孵育试验过程在血液筛查中是否存在差异。方法随机留取常规献血者血液筛查中检出的抗-HCV反应性的血液标本180(人)份作HCVRNA检测,并用RIBA和不同于血站常规抗-HCV筛查的酶免试剂作抗-HCV复测;依据ORTHO HCV 3.0 ELISA检测试剂说明书中的长、短2种孵育检测程序,同时作对比检测。结果 180份初筛抗-HCV阳性标本中,有16份ORTHO HCV 3.0 ELISA 2种检测程序的检测结果不一致,其中5份为短孵育试验反应性、11份为长孵育试验反应性,短孵育试验漏检2份被确证抗-HCV阳性标本。ORTHO HCV 3.0 ELISA试剂的长孵育检测程序灵敏度高于短孵育试验程序,2种试验程序的S/CO值分布没有差别,但RIBA不确定标本其S/CO值分布在一定的灰区范围内。结论在献血人群血液筛查中,采用具有更高灵敏度的长孵育酶免程序和设定合理的结果判定灰区,有助于预防输血传播HCV,提高血液的安全。Objective To check if there was a difference between the two test procedures of ORTHO HCV 3.0 ELISA test system for the blood donor screening. Methods A total of 180 storage samples,which were screened out from the rou-tine blood donors, underwent anti-HCV detection and the supplementary assays of HCV RNA. RIBA and other anti-HCV ELISA kit were implemented. The samples were tested repeatedly with two test procedures of ORTHO HCV 3.0 ELISA as- say, and both of the trials were performed according to the operation instruction manually under the same experimental con- dition. Results The results of 16 out of 180 samples were inconsistent,and 5 samples were reactive with short incubation test procedure, and 11 samples were reactive with standard incubation test procedure. Two confirmed anti-HCV positive sam-ples were missed by short incubation test procedure. The standard incubation test procedure of ORTHO HCV 3.0 ELISA was much more sensitivity. The S/CO value distribution between two test procedures showed no significant differences, but some of the S/CO values of RIBA indeterminate samples were within certain range of the gray zone. Conclusion For the blood donor population screening, both the choice of a much more sensitive anti-HCV test procedure and a reasonable estab-lishment of gray zone are necessary for preventing the transfusion transmitted infected hepatitis C virus.

关 键 词：丙型肝炎病毒 重组免疫印迹试验 ELISA 献血者 血液筛查 孵育试验 灵敏度 

分 类 号：R446.6[医药卫生—诊断学]