双抗原夹心ELISA法与间接ELISA法检测丙型肝炎病毒抗体对比分析

Comparative Analysis of Detection of Hepatitis C Virus Antibodies by Double Antigen Sandwich ELISA and Indirect ELISA

目的分别探讨双抗原夹心酶联免疫吸附法(Enzyme-Linked Immunosorbent Assay, ELISA)与间接ELISA法对丙型肝炎病毒(Hepatitis C virus, HCV)抗体(抗-HCV)的临床检测价值。方法回顾性分析2016年1月～2019年2月期间在本院进行无偿献血的100人次(100份标本)的临床资料,其中包括抗-HCV阴性标本79份,抗-HCV阳性标本21份,上述所有标本均需接受双抗原夹心ELISA法与间接ELISA法检测,分析不同检测方法的阳性检出率、特异度与准确度。结果双抗原夹心ELISA法的阳性检出率为97.47%,间接ELISA法的阳性检出率为86.08%,不同检测方法阳性检出率对比,差异有统计学意义(P <0.05);双抗原夹心ELISA法的准确度与特异度分别为98.00%、100.00%,间接ELISA法为85.00%、80.95%,不同检测方法对比,差异有统计学意义(P <0.05)。结论与间接ELISA法相较而言,双抗原夹心ELISA法为检测抗-HCV阳性标本的有效手段,且阳性检出率与特异度均较高,利于临床应用。

Objective To investigate the clinical value of double antigen sandwich Enzyme-Linked Immunosorbent Assay (ELISA) and indirect ELISA for Hepatitis C virus (HCV) antibody (anti-HCV). Methods The clinical data of 100 people (100 specimens) who donated blood in our hospital from January 2016 to February 2019 were retrospectively analyzed, including 79 anti-HCV-negative specimens and 21 anti-HCV-positive specimens. All the specimens above were tested by double antigen sandwich ELISA and indirect ELISA, and the positive detection rate, specificity and accuracy of different detection methods were analyzed. Results The positive detection rate of double antigen sandwich ELISA was 97.47%, and the positive detection rate of indirect ELISA was 86.08%, the difference was statistically significant (P < 0.05);The accuracy and specificity of double antigen sandwich ELISA were 98.00% and 100.00%, respectively. The indirect ELISA method was 85.00% and 80.95%. The difference was statistically significant (P < 0.05). Conclusion Compared with indirect ELISA, double antigen sandwich ELISA is an effective method for detecting anti-HCV positive specimens, and the positive detection rate and specificity are high, which is beneficial to clinical application.