摘要
目的:研究双抗原夹心法和间接法酶联免疫吸附试验(ELISA)检测丙型肝炎病毒(HCV)抗体的临床价值。方法:选取输血前、术前及孕前拟行HCV抗体检测的患者1674例,采用促凝管取患者空腹肘静脉血5ml,以3000r/min离心10min后取上清-20℃保存备用,分别采用间接ELISA法和双抗原夹心ELISA法检测抗-HCV抗体,所有操作均严格按照试剂盒内说明书要求完成,采用一致性Kappa检验分析间接法和双抗原夹心法诊断价值。结果:上海科华间接法、英科新创间接法和北京万泰双抗原夹心法对HCV检出率分别为4.30%、4.06%和3.52%(P>0.05),且三种检测试剂吸光度值/临界值(S/CO)差异均无统计学意义(P>0.05);以确证实验结果为“金标准”,间接ELISA法检测HCV灵敏度为94.00%,特异度为98.27%,阳性预测值为62.67%,阴性预测值为99.81%,准确率为98.15%,一致性Kappa为0.743;双抗原夹心法检测HCV灵敏度为97.91%,特异度为99.26%,阳性预测值为79.66%,阴性预测值为99.94%,准确率为99.22%,一致性Kappa为0.875;McNemar检验结果显示,间接法和双抗原夹心法检测HCV结果比较差异有统计学意义(P<0.05)。结论:双抗原夹心ELISA法用于HCV检测灵敏度和特异度均明显高于间接ELISA法,对控制HCV感染和传播具有较高临床价值和应用前景。
Objective:To study the clinical value of double antigen sandwich method and indirect enzyme-linked immunosorbent assay(ELISA)in the detection of hepatitis C virus(HCV)antibodies.Methods:1674 patients who underwent HCV antibody testing before blood transfusion,before operation and before pregnancy were selected and treated with a pro-coagulation tube to take 5 ml of fasting blood in cubital vein,and the supernatant was stored at-20°C after centrifuged at 3000 r/min for 10 min.The anti-HCV antibodies were detected by indirect ELISA and double antigen sandwich ELISA.All the operations were carried out in strict accordance with the instructions in the kit.The diagnostic value of indirect method and double antigen sandwich method was analyzed by consistency Kappa test.Results:The detection rates of HCV in Shanghai Kehua indirect method,Intec Products indirect method and Beijing Wantai double antigen sandwich method were 4.30%,4.06%and 3.52%respectively(P>0.05),and there was no significant difference in the absorbance value/critical value(S/CO)of three detection reagents(P>0.05).The experimental results were confirmed as“gold standards”,and the sensitivity,specificity,positive predictive value,negative predictive value,accuracy rate and consistency Kappa of indirect ELISA for HCV detection were 94.00%,98.27%,62.67%,99.81%,98.15%and 0.743.The sensitivity,specificity,positive predictive value,negative predictive value,accuracy rate and consistency Kappa of double antigen sandwich method for HCV detection were 97.91%,99.26%,79.66%,99.94%,99.22%and 0.875.The Mc Nemar test showed that there were statistically significant differences in the HCV results between indirect method and double antigen sandwich method(P<0.05).Conclusion:The sensitivity and specificity of double antigen sandwich ELISA for HCV detection are significantly higher than those of indirect ELISA.The former one has high clinical value and application prospects for controlling HCV infection and transmission.
作者
孙强
李艳琴
何宝明
SUN Qiang;LI Yanqin;HE Baoming(Hanzhong Central Hospital Inspection Section Shaanxi (Hanzhong 723000))
出处
《陕西医学杂志》
CAS
2019年第9期1231-1234,共4页
Shaanxi Medical Journal
基金
陕西省科学技术研究发展计划项目(S2015YFSF01732)
关键词
丙型肝炎病毒
抗体检测
酶联免疫吸附试验
双抗原夹心法
间接法
诊断价值
Hepatitis C virus
Antibody detection
Enzyme-linked immunosorbent assay
Double antigen sandwich method
Indirect method
Diagnostic value
