抗-HCV ELISA法检测结果在临界值附近的风险探讨

目的应用化学发光免疫分析（CLIA）法，检测抗-HCVELISA法结果在临界值附近（O．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-HCVELISA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．HCVELISA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，胶体会法阳性0份。cuA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-HCVELtSA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RNART—PCR荧光定量法进行检测，以保证结果的准确性。

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

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.