The performance of the / methylation assay is influenced by cancer stage, age, type and differentiation.

To investigate the clinicopathological factors affecting the assay performance and its application in lung cancer detection in Chinese population. A total of 455 subjects were recruited in this case-control study (302 untreated lung cancer patients, 153 normal subjects). Blood samples were collected before therapy and the level was measured with Epi proLung assay. The sensitivity was 75.6% at 84.8% specificity. Both markers showed stage-dependent sensitivity. was more sensitive to small-cell lung cancer and was more sensitive to poorly differentiated lung cancer. Sensitivity increased with age but was not affected by sex. The / sensitivity was significantly higher than that of protein markers. The / assay showed some values with more limitations in lung cancer early detection.