国内电化学发光法检测甲胎蛋白诊断肝癌的准确性和文献质量评价

Evaluation of Accuracy and Quality of Diagnostic Test of ECLIA in Detecting AFP for the Diagnosis of Liver Cancer in Chinese Patients

目的评价围内关于电化学发光免疫法检测甲胎蛋白诊断肝癌的准确性及文献质量。方法计算机检索中国生物医学文献数据库（1978～2005）和中国学术期刊网（1994～2005），纳入电化学发光法检测甲胎蛋白的诊断性试验。用自制表格提取数据，并应用诊断性试验的6条质量评价标准评价纳入研究质量。结果最初共检索到相关文献48篇，经逐篇阅读全文，排除综述、临床应用、多项指标联合检测、非肝癌诊断试验和AFP异质体的检测，最终仅纳入6篇文献，且无一篇可提取四格表数据进行准确性评价。结论目前国内有关电化学发光法检测甲胎蛋白的诊断性试验文献不多，质量也不高。其主要原因是研究设计时仅考虑了技术指标而忽视了诊断准确性的指标，所以不能得出电化学发光法检测甲胎蛋白的敏感度和特异度。

Objective To evaluate the accuracy and quality of diagnostic test of Electrochemiluminescence immunoassay （ECLIA） in detecting A-fetal protein （AFP） for the diagnosis of liver cancer in Chinese patients. Methods We searched Chinese Biological Medicine Database （CBM, 1978 to 2005） and China National Knowledge Infrastructure （CNKI, 1994 to 2005）. Diagnostic tests of ECLIA in detecting AFP for the diagnosis of liver cancer were included. Data were extracted, and the quality of included studies was evaluated according to the six criteria of diagnostic tests. Results Forty-eight studies were identified, but only 6 were included and none mentioned the indices about the accuracy. Conclusion The number of studies of ECLIA in detecting AFP for the diagnosis of liver caner is few and the quality is poor. We cannot draw the conclusion that ECLIA is better for sensitivity and specificity.