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机构地区:[1]上海市医学科学技术情报研究所,上海200031 [2]中国福利会,上海200031
出 处:《中国卫生资源》2014年第1期10-16,共7页Chinese Health Resources
摘 要:目的 :系统评价不同乙肝表面抗体定量测定诊断试验的准确性,为政府确定乙肝表面抗体定量检测主流方法提供理论依据。方法 :通过检索MEDLINE、EMBASE、EBM REVIEWS、中国生物医学文献数据库、中文科技期刊全文数据库、万方数据库等收集文献,采用QUADAS开展文献质量评价,计算灵敏度、特异度、阳性似然比、阴性似然比等指标,拟合ROC曲线。结果 :共纳入28篇研究文献,共5 243例患者。以酶联免疫吸附试验为参照,时间分辨荧光免疫分析法、电化学发光免疫技术及微粒子酶免分析法合并敏感度、特异度及ROC曲线下面积分别为(0.97,0.92,0.982 2)、(0.94,0.77,0.971 5)、(0.90,0.94,0.965 2);以时间分辨荧光免疫分析法为对照,电化学发光免疫技术及微粒子酶免分析法合并敏感度、特异度及ROC曲线下面积分别为(0.92,0.96,0.989 0)、(0.91,0.99,0.991 8)。结论 :乙肝表面抗体定量方法时间分辨荧光免疫分析法、电化学发光免疫技术及微粒子酶免分析法检测准确性均较高,其中时间分辨荧光免疫分析法及微粒子酶免分析法相对较优,建议政府根据不同医疗机构的实际情况推广使用。Objective: To evaluate the accuracy of hepatitis B surface antibody quantitative determination diagnostic tests, and to provide a theoretical basis for governments decision making. Methods: Databases such as the MEDLINE, EMBASE, EBM REVIEWS, CBM, CNKI, Wanfang were searched. Related literatures were collected, and literature quality evaluation was implemented by using quality assessment of diagnostic accuracy studies ( QUADAS ) criteria. Sensitivity, specificity, positive likelihood ratio and negative likelihood ratio were calculated and ROC curve were fitted. Results: Twenty-eight studies were included, which contained a total of 5 243 cases of patients. Compared to enzyme linked immunosorbent assay ( ELISA ), time resolved fluoroisnmunoassay ( TRFIA ), electrochemiluminescence immunoassay ( ECLIA ) and micropartial immunoassay ( MEIA ) merged sensitivity, specificity and area under of the ROC curve were (0.97, 0.92, 0.982 2 ), ( 0.94, 0.77, 0.971 5 ) and ( 0.90, 0.94, 0.965 2 ), respectively. Compared to TRFIA, ECLIA and MEIA merged sensitivity, specificity and area under of the ROC curve were ( 0.92, 0.96, 0.989 0 ) and( 0.91, 0.99, 0.991 8 ), respectively. Conclusion: The accuracy of three kinds of hepatitis B surface antibody quantitative methods are all very high, in which TRFIA and MEIA are relatively better. The government should promote the use of these methods according to the actual situation of different medical institutions.
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