抗-HCV ELISA法检测结果在临界值附近的风险探讨  

Disscuion on Infection Risk of Patients with Results of Critical Value by Against-HCV ELISA Assay

作　　者：姚仁南[1] 孙阳[1] 陈玲[1] 陈娜云[1] 朱月华[1] 王连友 

机构地区：[1]解放军第97医院输血科,江苏省徐州市221004 [2]徐州红十字血液中心,221000

出　　处：《中华全科医学》2011年第9期1450-1451,共2页Chinese Journal of General Practice

基　　金：南京军区医学科技创新重点课题(08Z009)

摘　　要：目的应用化学发光免疫分析(CLIA)法,检测抗-HCV ELISA法结果在临界值附近(0.4≤S/CO<1)的血清标本,探讨HCV感染的风险性。方法笔者对19份抗-HCV ELISA法检测结果在临界值附近,胶体金法均阴性的血液标本,分别经抗-HCV ELISA法试剂①、试剂②、胶体金法和CLIA法试剂进行了检测。结果 HCV-CLIA法阳性16份、ELISA法试剂①和试剂②分别阳性5份9份,胶体金法阳性0份。CLIA法与ELISA法和胶体金法比较检出率灵敏度显著高于ELISA法(P<0.05或P<0.01)和胶体金法(P<0.01)。结论抗-HCV ELISA法检测结果在临界值附近的血液标本存在HCV感染的可能,尤其是献血者标本存在感染受血者的风险。对可疑标本应更进一步的应用丙型病毒性肝炎核心抗原检测法、CLIA法、核酸扩增和微流芯片法或RNA RT-PCR荧光定量法进行检测,以保证结果的准确性。Objective To investigate the risk of HCV infection in patients with the results of critical value（0.4 ≤ S/CO 〈 1 ） in serum samples by anti-HCV ELISA method. Methods Nineteen blood specimens with the critical value results by anti-HCV ELISA method and negative results by colloid gold method were again detected by anti-HCV ELISA reagent ①, anti-HCV ELISA reagent ②, and colloid gold method and HCV- Chemiluminescence immunoassay（CLIA） assay simultaneously. Results There were 16 specimens were with positive results by HCV-CLIA method,5 with positive results by reagent ①,9 with positive results by reagent ② and 0 with positive results by colloid gold method. Compared with ELISA and colloid gold reagent,the positive rate of CLIA was more sensitive than ELISA （P 〈 0.05 or P 〈 0.01 ） and colloid gold reagent （P 〈 0.01 ）. Conclusion Blood samples have the possibility infected by HCV at the critical value of anti-HCV ELISA assay results. In order to avoid the infection from the blood donors, all the suspicious samples should be further detected by HCV-cAg assay, nucleic amplification and microfluidic chip assay or RNA RT -PCR fluorescence quantitative assay, thus to assure a reliable result.

关 键 词：丙型肝炎病毒 HCV—CLIA法 酶联免疫吸附试验(ELISA) 胶体金法 

分 类 号：R512.63[医药卫生—内科学]