CAJ | 학술논문

目的：评估强生 VITROS FUSION 5．1全自动干片式生化仪校准品（KIT1：LOT0112；KIT3：LOT0322）两个校准包的基质效应。方法以 Olympus AU 5400全自动生化分析仪为参比系统，VITROS FU‐SION 5．1干化学分析仪为待评估系统，参照CLSI EP14‐A2文件对KIT1及KIT3校准包每个校准包3个水平随机排列在20份新鲜的患者标本之中，用待评估系统和参比系统分别对患者标本、KIT1进行血糖（GLU ）、尿素（URE‐A）、肌酐（CR）、尿酸（UA）测定，对KIT3校准包进行天门冬氨酸氨基转移酶（AST）、乳酸脱氢酶（LDH）、肌酸激酶（CK）测定。结果 KIT1校准包中GLU、CR相对于参比系统不存在基质效应，其他项目至少有一个水平存在基质效应，KIT3校准包中所有项目至少有一个水平存在基质效应。结论在日常检测中由仪器校准品基质效应造成不同系统间结果的差异是不能忽视的，应尽量减少基质效应带来的影响。通过定期开展不同仪器间比对是减少其影响的手段之一，也是实验室标准化过程中不可或缺的一部分。
목적：평고강생 VITROS FUSION 5．1전자동간편식생화의교준품（KIT1：LOT0112；KIT3：LOT0322）량개교준포적기질효응。방법이 Olympus AU 5400전자동생화분석의위삼비계통，VITROS FU‐SION 5．1간화학분석의위대평고계통，삼조CLSI EP14‐A2문건대KIT1급KIT3교준포매개교준포3개수평수궤배렬재20빈신선적환자표본지중，용대평고계통화삼비계통분별대환자표본、KIT1진행혈당（GLU ）、뇨소（URE‐A）、기항（CR）、뇨산（UA）측정，대KIT3교준포진행천문동안산안기전이매（AST）、유산탈경매（LDH）、기산격매（CK）측정。결과 KIT1교준포중GLU、CR상대우삼비계통불존재기질효응，기타항목지소유일개수평존재기질효응，KIT3교준포중소유항목지소유일개수평존재기질효응。결론재일상검측중유의기교준품기질효응조성불동계통간결과적차이시불능홀시적，응진량감소기질효응대래적영향。통과정기개전불동의기간비대시감소기영향적수단지일，야시실험실표준화과정중불가혹결적일부분。
Objective To evaluate the matrix effect of the calibration packages of calibrator KIT1 :LOT 0112 and KIT3 :LOT 0322 for the Johnson VITROS FUSION 5 .1 automatic dry chip analyzer .Methods Using the Olym‐pus AU5400 automatic biochemistry analyzer as the reference system ,and the VITROS FUSION 5 .1 dry type chemi‐cal analyzer as the undetermined evaluation system ,referring to the NCCLS EP14‐A2 files ,three levels for each pack‐age in the calibration packages of KIT1 and KIT3 were randomly arranged in 20 fresh patient samples ,GLU ,UREA , Cr and UA were detected for the calibrator KIT1 and AST ,LDH and CK were detected for the calibrator KIT3 by the reference system and undetermined evaluation system .Results Compared with the reference system ,GLU and CR in the KIT1 calibration package had no matrix effects and other items had at least a level with the presence of ma‐trix effects and among all items in KIT3 calibration package at least a level had the presence of matrix effect .Conclu‐sion In daily detection ,the difference between the results of different systems caused by the matrix effect of the in‐strument calibrator can not be ignored .Therefore the effect of matrix effect should be reduced as far as possible . Launching the comparison among different instruments at regular intervals is one of reducing its influence ,and also an indispensable part of laboratory standardization .