丙型肝炎病毒血清学检测的方法学评价

Methodological Evaluation of the Serological Detection of Hepatitis C Virus

目的比较酶联免疫吸附试验(ELISA)、化学发光微粒子免疫检测法(CMIA)、PCR-荧光探针法三种方法对同一种样本检测结果的一致性。方法 120例疑似丙型肝炎患者的血清标本同时用ELISA与CMIA检测HCV-Ab,PCR-荧光探针法检测HCV-RNA。结果在不考虑CMIA检测HCV-Ab结果为可疑的情况下,ELISA与CMIA检测HCV-Ab结果具有一致性。当CMIA检测HCV-Ab结果为可疑时,ELISA检测HCV-Ab的OD值与CMIA检测HCV-Ab的S/CO值没有相关性。当CMIA检测HCV-Ab结果为阳性时,ELISA检测HCV-Ab的OD值与PCR-荧光探针法检测HCV-RNA的含量没有相关性,CMIA检测HCV-Ab的S/CO值与PCR-荧光探针法检测HCV-RNA的含量也没有相关性。结论在临床检测丙型肝炎病毒感染时建议采用化学发光微粒子免疫检测法(CMIA)检测HCV-Ab的同时也采用PCR-荧光探针法检测HCV-RNA含量,这样不仅可以降低漏诊,同时也为临床抗病毒提供有效的医学数据。由于ELISA检测HCV-Ab仍然具有可靠性,对于基层医院,ELISA检测HCV-Ab仍是首选的方法。

Objective To compare the consistency on the results of the same samples determined by ELISA, CMIA and PCR-fluorescent-probe. Methods The HCV-Ab of 120 serum samples obtained from patients with suspected HCV was detected by ELISA and CMIA, and the HCV-RNA was detected by PCR-fluorescent-probe. Results When the results detected by CMIA were not considered suspiciously, results of the ELISA and CMIA in detection HCV-Ab were consistent. There was no correlation between the ELISA test HCV-Ab OD values and HCV-Ab S/CO values of CMIA, when the HCV-Ab results detected by CMIA were suspicious. However, when results detected by CMIA were positive, there was no correlation between the ELISA OD values and the RNA content of the HCV by PCR-fluorescence-probe, at the same time, there was no correlation between CMIA S/CO values and HCV-RNA content detected by PCR-fluoreseence probe, either. Conclusions In screening HCV infection clinically, we suggest applying CMIA plus PCR-fluorescence-probe methods. Thus not only the misdiagnosis will be reduced, but also more clinical effective antiviral medical data will be provided. ELISA remains the preferred method in detecting HCV-Ab in loacl hospitals, as it still has a high reliability.