Analytical Performance Test of Pancreas Cancer miRNA Chip

This study was conducted to identify reproducibility, repeatability, and specificity and to establish the evaluation basis through the analytical performance test of the pancreatic cancer microRNA (miRNA) diagnosis chip manufactured at the "Integrated Analysis of Next-Generation Bio-Data" in June 2016. There were 16 selected markers manufactured to be installed in the miRNA diagnosis chip exclusively for pancreatic cancer and used for analytical performance tests for the chip itself. Three analytical performance tests were performed (reproducibility, repeatability, and specificity). For the reproducibility test, the same subject had two test sessions repeated three times per each session. For repeatability analysis, two different subjects had two test sessions repeated three times per each session. Analytical specificity was analyzed by using hierarchical clustering analysis results, comparing the results of two repeated tests of normal miRNA, and the results of six repeated tests of patient group miRNA. As a result of analytical performance tests, coefficient of variance values of reproducibility and repeatability were 10 % or below, and patient groups with pancreatic cancer were significantly divided from normal groups obviously different by hierarchical clustering analysis results. Such tests confirmed that the miRNA diagnosis chip of pancreatic cancer, constructed with 16 markers, is quite suitable.