담도암 miRNA 진단 칩을 이용한 분석적 성능 시험

Objectives: This study`s purpose was to analyze the analytical performance test of miRNA diagnosis chip for a national project, Development of Multiple Biomarkers Using Integrated Analysis of Next Generation Bio-data, and it was attempted in June 2016. Methods: The evaluation indices of the analytical performance test were reproducibility, repeatability, and specificity. The analytical performance test of miRNA diagnosis chip for bile duct cancer were subjected to analysis of five markers. One same subject had two sessions of the test, and three times were repeated per each session for reproducibility analysis whereas two different subjects had two sessions of the test, and three times were repeated per each session for repeatability analysis. The mea-sured value taken from six times repeated test of patient group of bile duct cancer and the measured value taken from two times repeated test of normal group were compared by using hierarchical clustering analysis in order for specificity analysis. Results: As a result of analysis, all CV (coefficient of vari-ance) values of markers were 10% or below for reproducibility and repeatability, and patient group of bile duct cancer were significantly divided from normal group being completely different groups. Conclusions: Analytical performance test confirmed suitability of miRNA diagnosis chip designed for diagnosing bile duct cancer.