Author contributions: Meng W and Zhu HH contributed equally to this work; Meng W conducted the study, data collection, management and analysis, and drafted the manuscript; Zhu HH did data correction, designed the analysis strategy and did data interpretation, co-drafted and revised the manuscript, reviewed and edited the whole manuscript; Xu ZF performed quality control on ELISA work; Cai SR performed previous screening work and collection of serum samples; Dong Q performed helpful work in previous screening; Pan QR did part of ELISA work; Zheng S co-supervised the field activities and designed the study's analytical strategy; Zhang SZ co-designed the study, co-supervised the field activities and did quality assurance and control.
METHODS:We conducted a molecular epidemiology study in Hangzhou, China, from year 2006 to year 2008. Serum samples were collected from 93 CRC, 41 advanced adenomas, 137 adenomas, 47 non-adenomatous polyps, and 158 normal participants in a community setting. Serum M2-PK and carcinoembryonic antigen (CEA) were measured using Enzyme-linked immunosorbent assay. SPSS 16.0 software was used to perform data analysis. Area under the receiver operating characteristic curve (AUC), sensitivity, and specificities were estimated for serum M2-PK in diagnosis of colorectal lesions and compared with CEA.
RESULTS:Average serum M2-PK value among 158 normal people was 2.96 U/mL and not affected by gender (P = 0.47) or age (P = 0.59). Average serum M2-PK (U/mL) was 14.75 among stage Ⅲ and 13.10 among stage Ⅰ and Ⅱ CRC patients, about 4 times higher than that among normal people. Average serum M2-PK was 8.58, 6.70, 5.13 and 2.51 U/mL among advanced adenoma, adenomas, non-adenomatous polyps, and inflammatory bowel disease patients, respectively. AUC for serum M2-PK was greater than that for CEA among all colorectal lesions. AUC for serum M2-PK was 0.89 (0.84, 0.94) (95% confidence interval), higher than that for CEA [0.70 (0.62-0.79 The diagnostic sensitivity for all colorectal lesions increased with decrease in the cut-off value of serum M2-PK. The diagnostic sensitivity (%) of serum M2-PK was 100.00 for CRC, 95.12 advanced adenoma, 82.48 adenoma, and 82.98 non-adenomatous polyp. There were no CRC cases missed and 40.51% of BRIEF ARTICLE