Objective To Evaluation of Accuracy and Quality of Diagnostic Test of CEA for the Diagnosis of NSCLC in Chinese Patients. Methods We searched Chinese Biological Medicine Database (CBM, 1978 to 2009) and China National Knowledge Infrastructure (CNKI, 1994 to 2009). Diagnostic tests of CEA for the diagnosis of NSCLC were included. Data were extracted, and the quality of included studies was evaluated according to the six criteria of diagnostic tests. The heterogeneity test and The Summary Receiver Operating Characteristic (SROC) curve and meta-analyses were performed by MetaDisc. Results A total of 84 relevant articles were retrieved and 11 were included in our review. Eleven studies involving 925 patients (861 NSCLC patients, all diagnosed by the gold standard) were included. Meta-analyses showed that the heterogeneity among studies was high (P=0.000 2, I2=69.1%), the pooled sensitivity was 0.542 and the pooled specificity was 0.869. Subgroup analyses indicated that 5 of the studies which used the ECLIA (P=0.376, I2=5.4%, AUC= 0.748 3) and 4 of the studies which lung adenocarcinoma (P=0.186, I2=37.6%, AUC=0.900 2) and 4 of the studies which lung squamous cell carcinoma (P=0.955，I2=0.00%, AUC=0.762 0) had no heterogeneity. serum CEA is low sensitive and high specific on the diagnosis of NSCLC. The sensitivity and diagnostic accuracy rate of CEA were higher in adenocarcionoma than squamous cell cance. Conclusion CEA could be regarded as one of the reference tests in patients with NSCLC, Serum CEA is more sensitive and specific than lung squamous cell carcinoma on lung adenocarcinoma. but more high quality trials are required.
The Standards for reporting diagnostic accuracy studies (STARD) 2015 is a revision of the STARD 2003 on the checklist and flow chart, on the basis of the new evidences of potential bias and applicability, to better guide the application of diagnostic test in clinical practices. Currently, the interpretation and application in China is still based on STARD 2003. This review will describe the application status of the original version and introduce the updated standards for reporting diagnostic accuracy studies.