不同检测系统间参考区间转移可行性的方法比对研究  

Comparative Study on the Feasibility of Reference Interval Transfer Between Different Detection Systems

作　　者：雷航[1] 刘艳婷[1] 魏容[1] 何成钦 肖光军[1] LEI Hang;LIU Yan-ting;WEI Rong;HE Cheng-qin;XIAO Guang-jun(Department of Clinical Laboratory and Basic Laboratory,Suining Central Hospital,Suining 629000,Sichuan,China)

机构地区：[1]遂宁市中心医院检验科,四川遂宁629000

出　　处：《医学信息》2023年第18期119-123,共5页Journal of Medical Information

摘　　要：目的以TBIL和DBIL血清参考区间为例,探讨通过方法比对分析不同检测系统间参考区间转移的可行性。方法按照美国国家临床实验室标准委员会(NCCLS)EP9-A2文件的比对方案,以罗氏配套检测系统为参考系统(X)、自建的非配套检测系统为待评价检测系统(Y),使用40份新鲜样品进行TBIL和DBIL检测结果的比对,并通过其线性回归方程对参考系统TBIL、DBIL的参考区间进行转移,从而得到非配套检测系统TBIL、DBIL的参考区间,并通过遂宁地区2655例20~79岁表观健康成人的TBIL和DBIL检测结果来验证该参考区间的适宜性。同时,分别使用前期自建的参考区间和转移所得的参考区间对2021年7月我院11254例20~79岁门诊患者的TBIL、DBIL检测结果进行临床判断,比较两参考区间对患者检测结果临床判断的一致性。结果两检测系统TBIL、DBIL检测结果比较,差异有统计学意义(P<0.05),其线性回归方程依次为Y=0.8886X+0.262、Y=0.7451X+0.3463,相关系数R2依次为0.9989、0.9882。通过该回归方程得到非配套检测系统TBIL的参考区间依次为:男≤23.37μmol/L,女≤18.92μmol/L,男/女≤20.70μmol/L;DBIL参考区间则为≤6.31μmol/L。对该参考区间进行验证,各年龄段的符合率均≥90%,验证均通过;使用该参考区间和自建的参考区间对患者检测结果进行临床判断,两参考区间临床结果比较,差异无统计学意义(P>0.05)。结论通过方法比对可实现参考区间在不同检测系统间的转移,提高临床实验室非配套检测系统参考区间的适宜性,而与自建参考区间比较,具有操作简单、成本低廉等优点。Objective To analyze the feasibility of reference interval transfer between different detection systems by method comparison,taking TBIL and DBIL serum reference intervals as examples.Methods Comparison protocol according to National Committee for Clinical Laboratory Standards(NCCLS)EP9-A2 document,40 fresh samples were used to analyze the detection results of TBIL and DBIL.Taking the Roche matching detection system as the reference system(X)and the self-built non-matching detection system as the evaluation detection system(Y),40 fresh samples were used to compare the test results of TBIL and DBIL,and the reference interval of TBIL and DBIL of the reference system was transferred through its linear regression equation,so as to obtain the reference interval of TBIL and DBIL of the non-matching detection system.The suitability of the reference interval was verified by the test results of TBIL and DBIL of 2655 apparently healthy adults aged 20-79 years in Suining area.At the same time,the clinical judgment of TBIL and DBIL test results of 11254 outpatients aged 20-79 years in our hospital in July 2021 was carried out by using the self-built reference interval and the transferred reference interval respectively,and the consistency of the two reference intervals in the clinical judgment of patients'test results was compared.Results There were statistically significant differences in TBIL and DBIL between the two detection systems(P<0.05),while the linear regression equation was Y=0.8886x+0.262,Y=0.7451x+0.3463,and the correlation coefficient R2 was 0.9989 and 0.9882,respectively.Through the regression equation,the reference intervals of TBIL for non-matching detection systems were as follows:≤23.37μmol/L for men,≤18.92μmol/L for women,and≤20.70μmol/L for men/women.The reference interval of DBIL was≤6.31μmol/L.The reference interval was verified,and the coincidence rate of each age group was≥90%,and the verification was passed.The clinical judgment of the patient's test results was performed using the ref

关 键 词：总胆红素 直接胆红素 参考区间 

分 类 号：R446.1[医药卫生—诊断学]