定量检测BCR-ABL(P210)转录本水平室内质控体系的完善及多中心推广应用  

The establishment and multicenter application of internal quality control system for real-time quantitative PCR detection of BCR-ABL(P210)transcript level

作　　者：何娜[1] 谷朝阳 李乾鹏 周辉 初丽娜 马道新[1] He Na;Gu Chaoyang;Li Qianpeng;Zhou Hui;Chu Li'na;Ma Daoxin(Institute of Hematology,Qilu Hospital of Shandong University,Jinan 250012,China;Department of Hematology,Weifang People's Hospital,Weifang 261000,China;Department of Hematology,Affiliated Hospital of Jining Medical University,Jining 272007,China;Clinical Lab,Yantai Yuhuangding Hospital,Yantai 264099,China)

机构地区：[1]山东大学齐鲁医院血液病研究室,济南250012 [2]潍坊市人民医院血液科,潍坊261000 [3]济宁医学院附属医院血液科,济宁272007 [4]烟台毓璜顶医院检验科,烟台264099

出　　处：《中华血液学杂志》2022年第7期562-567,共6页Chinese Journal of Hematology

基　　金：国家自然科学基金(81873439)。

摘　　要：目的建立完善的BCR-ABL(P210)监测室内质控体系, 确保检测结果的长期稳定性和室间可比性, 并在3家医院进行推广应用。方法山东大学齐鲁医院血液病研究室(H1)利用实时定量PCR(RQ-PCR)检测质控物的BCR-ABL(P210)转录本水平, 完善质控体系的可靠性和稳定性;赴其他3家医院(H2~H4)现场进行测定前质量控制检查, 同时邮寄给各家医院25套质控物进行检测;采用Levey-Jennings质控图结合Westgard多规则方法, 对各家医院的标准曲线斜率、截距及检测结果进行统计学的质量判断, 作出质控评价。结果①成功建立并完善了测定前质控检查、测定中质控统计判断、测定后质控评价的BCR-ABL(P210)转录本水平监测的室内质控体系。②4家医院标准曲线的斜率、截距均在控。③多中心质控物判断结果:H1医院中、低浓度质控物各出现1次"12s"警告, 判断为在控;H2医院3种浓度质控物各出现1次"12s"警告, 判断为"22s"失控;H3医院高浓度质控物违反1次"13s"规则, 低浓度质控物出现1次"12s"警告, 判断为"13s"失控;H4医院各质控物均在控。④质控评价及纠正:2家医院在控, 另2家医院各出现1次失控, 查找原因进行纠正后未再出现失控。⑤多中心质控物原始数值比较:4家医院之间高浓度质控物结果差异有统计学意义, 中、低浓度质控物结果差异无统计学意义。⑥多中心质控物国际标准值(IS值)比较:H2、H3医院的IS数值显著高于H1医院, H2医院显著高于H3医院。结论建立了一套完善稳定的BCR-ABL(P210)转录本室内质控体系, 有效地保证临床检测结果的稳定性和室间可比性, 并成功完成了多中心的推广应用。Objective The study aims to establish a perfect BCR-ABL(P210)internal quality control system and ensure the long-term stability and comparability of the detection results between laboratories and to popularize and apply it in the three hospitals.Methods The Qilu Hospital of Shandong University(H1)prepared a set of the BCR-ABL(P210)quality control substances to establish and improve internal quality control system.We went to other three participating hospitals(H2,H3,and H4)to inspect quality control before the measurement.In addition,we mailed 25 sets of quality control substances to each of the hospital for detection.The slope and intercept of the standard curve of each hospital and the detection results were analyzed and statistically judged using the Levey-Jennings quality control chart combined with the Westgard multirule theory.Then,we made a quality control evaluation.Results①An internal quality control system for the BCR-ABL(P210)transcript levels monitoring was successfully established for the quality inspection before the measurement,statistical judgment during the measurement,and evaluation after the measurement.②Both the slope and intercept of the standard curve of the four hospitals was under control.③The multicenter quality control substance judgment results were as follows:for H1 hospital,two times of"12s"warning were found in the middle-level quality control substance,which was judged as being under control;for H2 hospital,one time of"12s"warning was found for each quality control substance,which was judged as being"22s"out of control;for H3 hospital,its high-level quality control substance violated the"13s"rule,and low-level quality control substance appeared"12s"warning,which was judged as"13s"out of control;and all quality control substances were under control in H4 hospital.④The quality control evaluation and correction were as follows:two hospitals were under control,and the other two hospitals had an"out of control."We found out the reason for the out of control and corrected them.⑤T

关 键 词：聚合酶链反应 融合蛋白质类 BCR-ABL 室内质量控制 推广应用 

分 类 号：R197.32[医药卫生—卫生事业管理]