丙型肝炎核心抗原酶联免疫检测试剂的临床应用

目的评价1种国产丙型肝炎病毒核心抗原(HCV-cAg)酶联免疫检测试剂的敏感性以及在临床应用效果。方法采用1种酶联免疫试剂盒(ELISA)检测HCV游离核心抗原,分别对2808名献血者、随机抽取的1099名门诊病人及244名抗-HCV阳性者血清作HCV-cAg检测,再进一步对献血者、门诊病人HCV-cAg阳性血清作HCV-RNA和抗-HCV检测,对244名抗-HCV阳性血清作HCV-RNA检测。结果献血者2808份血清,经HCV-cAg试剂检测出HCV-cAg阳性1例,此例血清HCV-RNA亦为阳性;随机抽取的1099份门诊病人血清标本,检测出HCV-cAg阳性8份,其中抗-HCV阳性5份(5/8),HCV-RNA阳性5份(5/6,有2份HCV-cAg阳性标本因血清不足未作RT-PCR和FQ-PCR);244名抗-HCV阳性的血清中检测出HCV-cAg阳性52份,HCV-RNA阳性49份(49/52),2种方法符合率为94.23%;另外,检测为HCV-cAg阴性的192份标本中,HCV-RNA阳性68份(68/192)。结论该HCV-cAg检测试剂在不同的临床样本中具有很好的应用价值。

Clinical application of enzyme immunoassay for the detection of hepatitis C virus core antigen

Objective To evaluate the sensitivity of the enzyme immunoassay(EIA)kits of Hunan Jynda Gene Co.Ltd in detecting hepatitis C virus core antigen.Methods Blood samples from 2808 blood donors,1909 outpatients,and 244 anti-HCV( )cases were randomly selected and hepatitis C virus core antigen(HCV-cAg)was detected with EIA kit.Samples found out to be HCV-cAg( )were further tested for HCV-RNA and anti-HCV antibody.Results In 2808 blood donors,one case(0.04%)with both HCV-cAg( )and HCV-RNA( )was found.In 1099 outpatients,8 cases(0.73%)of HCV-cAg( )was detected,and 5 of them were anti-HCV( ).Of these 8 HCV-cAg( )cases,6 were tested for HCV-RNA and 5 were found positive.The other 2 cases of HCV-cAg( )were not tested for HCV-RAN because of inadequate specimen.Of the 244 anti-HCV( )cases,HCV-cAg( )was found in 52,and HCV-RNA( )in 49.The other 192 HCV-cAg(-)were also tested for HCV-RNA,and 68 of them were HCV-RNA( ).Conclusion EIA kit for the detection of HCV-cAg in human serum or plasma can be used clinically in prevention of the HCV transmission.