CAJ | 학술논문

目的：探讨不同生化分析仪检测结果的可比性和临床可接受性。方法以罗氏试剂、罗氏cfas校准液、罗氏7600全自动生化分析仪为标准检测系统，标佳试剂及自带校准液、雅培AEROSET 全自动生化分析仪为待检测系统（以下简称雅培A），德赛试剂及自带校准液、另一台雅培 AEROSET 全自动生化分析仪为另一待检测系统（以下简称雅培M ）。用罗氏7600、雅培A和雅培M 3个检测系统同时测定40份新鲜人血清的总蛋白（T P ）、肌酐（Cr）两项生化指标，并将所得结果根据NCCLS提供的标准化文件EP9-A中的对比方法进行线性回归分析。结果同一新鲜混合血清在3台仪器上检测C V均小于2．5％，精密度良好，结果稳定；两个项目的相关系数 R2＞0．95，说明各检测系统有良好的线性和相关性；A 系统 TP在各医学决定水平处和Cr在医学决定水平中值处SE％＜1/2CLIA′88允许误差（Ea％），M系统Cr在医学决定水平高值处的 SE％＜1/2CLIA′88 Ea％，偏倚可接受；其余值则均大于1/2CLIA′88 Ea％。结论实验室内对比试验能有效对实验室检测能力进行质量监控，实验室其他项目对比工作需不断完善。
목적：탐토불동생화분석의검측결과적가비성화림상가접수성。방법이라씨시제、라씨cfas교준액、라씨7600전자동생화분석의위표준검측계통，표가시제급자대교준액、아배AEROSET 전자동생화분석의위대검측계통（이하간칭아배A），덕새시제급자대교준액、령일태아배 AEROSET 전자동생화분석의위령일대검측계통（이하간칭아배M ）。용라씨7600、아배A화아배M 3개검측계통동시측정40빈신선인혈청적총단백（T P ）、기항（Cr）량항생화지표，병장소득결과근거NCCLS제공적표준화문건EP9-A중적대비방법진행선성회귀분석。결과동일신선혼합혈청재3태의기상검측C V균소우2．5％，정밀도량호，결과은정；량개항목적상관계수 R2＞0．95，설명각검측계통유량호적선성화상관성；A 계통 TP재각의학결정수평처화Cr재의학결정수평중치처SE％＜1/2CLIA′88윤허오차（Ea％），M계통Cr재의학결정수평고치처적 SE％＜1/2CLIA′88 Ea％，편의가접수；기여치칙균대우1/2CLIA′88 Ea％。결론실험실내대비시험능유효대실험실검측능력진행질량감공，실험실기타항목대비공작수불단완선。
Objective To study the comparability and clinical acceptability of the results detected by different biochemistry analytical systems .Methods Detection reagents ,cfas calibration solution and 7600 automatic biochemi-cal analyzer of Roche company were taken as standard detection system (Roche 7600 system) .One experiment system (Abbott A system) included detection reagents and calibration solution of Biaojia company ,and AEROSET automatic biochemical analyzer of Abbott company .The other experiment system(Abbott M system) included detection rea-gents and calibration solution of Desai company ,and another AEROSET automatic chemical analyzer .Levels of total protein(TP) and creatinine(Cr) in 40 fresh serum samples were detected by the three systems ,and the results were analyzed by linear regression analysis ,according to EP9-A document of Clinical and Laboratory Standard Institute (CLSI) .Results Coefficient of variability of the results detected by the three systems was less than 2 .5% ,with fine precision and stability .Correlation coefficients (R2 ) of TP and Cr were both more than 0 .95 ,indicating that there were fine linearity and correlation between the three systems .System error(SE% ) of TP detected by Abbott A sys-tem at various medical decision levels (MDL) and SE% of Cr detected at mid-value of MDL ,and SE% of Cr detected by Abbott M system at high-value of MDL were all less than the half value of allowed error (Ea% ) ruled in Clinical Laboratory Improvement Amendments of 1988(CLIA′88) ,indicating that the bias were acceptable .Other SE% val-ues were more than the half value of Ea% ruled in CLIA′88 .Conclusion Internal comparative tests in laboratory might be helpful for the quality monitoring of the performance of detection .