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.
目的 通过同一实验室两台化学发光仪器间测定血清β-hCG的方法比对和预期偏倚评估，探讨两台化学发光仪器之间测定数据是否具有可比性，或检测结果的偏倚是否在允许范围内，以确保测定结果具有可比性和一致性，为实验室不同仪器测定结果互认提供依据。 方法 2009年11月2日-6日，参考美国CLSI EP9-A2文件，以Roche cobas e 601为参比方法，Roche cobas e 411为待评方法，用40份患者新鲜血清标本，测定血清β-HCG，对两台仪器之间的预期偏倚进行评估。 结果 相关系数 r =0.9988，截距a =3.48，斜率b =1.03，以20%为允许限，两仪器测定的结果在允许范围内。 结论 两仪器测定血清β-HCG的偏倚在实验室允许范围内，测定具有很好的相关性，结果具有可比性。