CAJ | 학술논문

目的：通过日立7600全自动生化仪（日立7600）与罗氏c311全自动生化仪（罗氏c311）检测血清葡萄糖（Glu）项目进行比对分析和偏倚评估，建立分析模式，探讨两台仪器测定结果的可比性。方法参考 NCCLS EP15-A、EP6-A文件，先检测日立7600的精密度与线性范围，结果与厂家声明一致后，再参考 NCCLS EP9-A2文件进行比对分析。将40例血清标本按Glu浓度水平分为Ⅰ组（＜2．80 mmol/L ，4例），Ⅱ组（2．80～6．11 mmol/L ，16例），Ⅲ组（6．12～8．30 mmol/L ，12例），Ⅳ组（8．31～14．00 mmol/L ，4例），Ⅴ组（14．01～44．20 mmol/L ，4例）。各组分别在日立7600（比对系统）与罗氏c311（实验系统）上进行检测，计算实验系统与比对系统之间的相对偏差。最后以CLIA′88允许总误差的1/3为标准，判断两台仪器测定结果的可比性。结果日立7600的精密度与线性范围均达到了厂家声明的性能要求。浓度在2．80、7．00、11．10 mmol/L 3个Glu的医学决定水平处的预期偏倚（Bc）的95％可信区间分别为2．68～2．70 mmol/L、6．72～6．80 mmol/L、10．59～10．63 mmol/L ，均满足相应允许浓度范围。结论血清Glu测试在罗氏c311与日立7600的不同检测系统间具有可比性，为进一步全面开展比对分析奠定了基础。
목적：통과일립7600전자동생화의（일립7600）여라씨c311전자동생화의（라씨c311）검측혈청포도당（Glu）항목진행비대분석화편의평고，건립분석모식，탐토량태의기측정결과적가비성。방법삼고 NCCLS EP15-A、EP6-A문건，선검측일립7600적정밀도여선성범위，결과여엄가성명일치후，재삼고 NCCLS EP9-A2문건진행비대분석。장40례혈청표본안Glu농도수평분위Ⅰ조（＜2．80 mmol/L ，4례），Ⅱ조（2．80～6．11 mmol/L ，16례），Ⅲ조（6．12～8．30 mmol/L ，12례），Ⅳ조（8．31～14．00 mmol/L ，4례），Ⅴ조（14．01～44．20 mmol/L ，4례）。각조분별재일립7600（비대계통）여라씨c311（실험계통）상진행검측，계산실험계통여비대계통지간적상대편차。최후이CLIA′88윤허총오차적1/3위표준，판단량태의기측정결과적가비성。결과일립7600적정밀도여선성범위균체도료엄가성명적성능요구。농도재2．80、7．00、11．10 mmol/L 3개Glu적의학결정수평처적예기편의（Bc）적95％가신구간분별위2．68～2．70 mmol/L、6．72～6．80 mmol/L、10．59～10．63 mmol/L ，균만족상응윤허농도범위。결론혈청Glu측시재라씨c311여일립7600적불동검측계통간구유가비성，위진일보전면개전비대분석전정료기출。
Objective To investigate the comparability of detection results between Hitachi 7600-020 biochem-ical analyzer (Hitachi 7600) and Roche c311 biochemical analyzer (Roche c311) through detecting serum glucose (Glu) level and estimating bias .Methods Referring to NCCLS EP15-A and EP6-A documents ,the experiment of precision and linearity range were firstly run in Hitachi 7600 ,which was consistent with the manufacturer claim .Then the further comparative analysis was estimated according to EP 9-A2 document .According to the Glu level ,all 40 ser-um samples were classified into group Ⅰ(<2 .80 mmol/L ,n=4) ,group Ⅱ (2 .80-6 .11 mmol/L ,n=16) ,group Ⅲ(6 .12-8 .30 mmol/L ,n=12) ,group Ⅳ(8 .31 -14 .00 mmol/L ,n=4) ,group Ⅴ (14 .01 -44 .20 mmol/L ,n=4) . The Glu concentration of these samples were detected by Hitachi 7600 (comparative system ) and Roche c311 (test system) ,respectively .The relative deviation between the comparative system and test system was analyzed .Finally 1/3 of CLIA'88 total error as a goal ,the comparability between two systems was judged .Results The estimation of the linear range and the precision in Hitachi 7600 were in compliance with the manufacturer claim .The 95% confidence intervals of the predicted bias(Bc)in the Glu concentration of three medical decision levels were 2 .68-2 .70 mmol/L , 6 .72-6 .80 mmol/L and 10 .59 -10 .63 mmol/L ,respectively .All were accepted for the allowable concentration range .Conclusion The comparability of the Glu detection between Hitachi 7600 and Roche c311 built the foundation for the further comparative analysis .