检验医学与临床2019，Vol.16Issue(4)：448-452,5.DOI:10.3969/j.issn.1672-9455.2019.04.005
ISO15189认可关于CYP2C19基因多态性检测性能验证评价
Evaluation on determination performance verification of CYP2C19 gene polymorphisms in ISO15189 accreditation
摘要
Abstract
Objective To evaluate the analytical performance of fluorescence quantitative PCR in detecting human CYP2C19gene polymorphisms.Methods According to the requirements of ISO15189accreditation, the accuracy (compared with the gold standard), specificity, precision, limit of lowest detection and anti-interference ability of the reagent kit were evaluated.Results In the comparison of the results between fluorescence quantitative PCR and Sanger sequencing for detecting 20clinical samples, the coincidence rate of accuracy was 100％ (which of sequencing results was 100％);in 10clinical samples, the results of 3genotype locus detected by fluorescence quantitative PCR and Sanger sequencing all were wild type, the coincidence rate of specificity was 100％;the results of 15times repeated detection in clinical sample by fluorescence quantitative PCR were in full accord, moreover the Ct value CV≤5％;the lowest detection limit of the kit was 0.550ng/μL;after adding three interfering substances of hemoglobin, bilirubin and triglyceride into the blood samples with known genotype, and the results determined by the kit had 100％coincidence rate with the control results.Conclusion The performance verification of fluorescence of quantitative PCR for detecting human CYP2C19polymorphisms meets the ISO15189accreditation requirements and is suitable for the clinical application.关键词
CYP2C19/基因多态性/性能验证/ISO15189认可Key words
CYP2C19/polymorphisms/performance verification/ISO15189 accreditation分类
医药卫生引用本文复制引用
师志云,贾伟,梁小燕,张玉英,赵玥,赵倩颖,郭雅琪,何学虎,董洁,赵志军..ISO15189认可关于CYP2C19基因多态性检测性能验证评价[J].检验医学与临床,2019,16(4):448-452,5.基金项目
宁夏自然科学基金资助项目(NZ16153) （NZ16153）
宁夏高等学校科学研究项目(NGY2015072) （NGY2015072）
宁夏医科大学教育教学改革研究项目(NYJY1861) （NYJY1861）
