CAJ | 학술논문

目的：探讨同一实验室不同生化仪器之间检测结果的可比性。方法以刚通过仪器厂家校准过的Hitachi 7180及为参比系统（X），以ARCHITECT c i16200为待评系统（Y），每个比对项目每天找出8个新鲜血清样本(浓度分布参照E P9-A2要求)，每个样本分别在两个系统上重复测定两次。计算待评系统与参比系统之间的相关性及偏倚，以相关回归分析中R2>0.95及偏倚小于美国CLLA，88最大允许误差的1/2为评判标准，评判两系统之间的相关性及偏倚程度。结果两系统比对项目相关系数R2值均大于0.95，两系统比对项目之间的偏倚都小于美国CLLA，88最大允许误差的1/2。结论两检测系统中的比对项目检测结果具有可比性，符合临床需求。
목적：탐토동일실험실불동생화의기지간검측결과적가비성。방법이강통과의기엄가교준과적Hitachi 7180급위삼비계통（X），이ARCHITECT c i16200위대평계통（Y），매개비대항목매천조출8개신선혈청양본(농도분포삼조E P9-A2요구)，매개양본분별재량개계통상중복측정량차。계산대평계통여삼비계통지간적상관성급편의，이상관회귀분석중R2>0.95급편의소우미국CLLA，88최대윤허오차적1/2위평판표준，평판량계통지간적상관성급편의정도。결과량계통비대항목상관계수R2치균대우0.95，량계통비대항목지간적편의도소우미국CLLA，88최대윤허오차적1/2。결론량검측계통중적비대항목검측결과구유가비성，부합림상수구。
Objective To study the comparability of the testing results between different biochemical analyzers under the same laboratory conditions. Methods The comparative system(X) was Hitachi 7180 which was calibrated by the instrument manufacturer in days. The test method system(Y) was ARCHITECT ci16200. each item was detected every days with 8 fresh serum samples(concentration distribution according to EP9-A2 requirements), each sample were determined in the two systems for two times. like this for 5 days. Calculate the reference correlation and the bias between the two systems. using the judgment standard with R2>0.95 and 1/2CLLA,88. Results The correlation coefficient of al items is greater than 0.95 and the bias is less than 1/2CLLA,88. Conclusion The results tested by two analysis systems are comparable , and consistent with the clinical demand.