CAJ | 학술논문

目的：以乳酸脱氢酶（LDH）为例，验证罗氏新批号自动生化分析系统校准品（Cfas）的检测性能。方法在罗氏Cobas C501全自动生化分析仪上，使用20份新鲜患者血清样本，于Cfas批号更换前后分别检测LDH。采用Bland‐Altman散点图方法，用Medcalc12．7．0统计学软件分析检测结果。结果散点图中，有19个点位于一致性界限（LoA）范围内，超过所有点的95％；LDH两次测定结果差值均数仅为－0．2 U／L ，与差值均数为0的线非常接近；LDH两次测量结果最大差值为8U／L，最大比对偏差为2．48％，小于比对偏差可接受标准（2．87％），这种偏差幅度在临床上可以接受。结论在更换Cfas批号前后LDH的两次检测结果具有一致性，新批号Cfas性能验证通过。
목적：이유산탈경매（LDH）위례，험증라씨신비호자동생화분석계통교준품（Cfas）적검측성능。방법재라씨Cobas C501전자동생화분석의상，사용20빈신선환자혈청양본，우Cfas비호경환전후분별검측LDH。채용Bland‐Altman산점도방법，용Medcalc12．7．0통계학연건분석검측결과。결과산점도중，유19개점위우일치성계한（LoA）범위내，초과소유점적95％；LDH량차측정결과차치균수부위－0．2 U／L ，여차치균수위0적선비상접근；LDH량차측량결과최대차치위8U／L，최대비대편차위2．48％，소우비대편차가접수표준（2．87％），저충편차폭도재림상상가이접수。결론재경환Cfas비호전후LDH적량차검측결과구유일치성，신비호Cfas성능험증통과。
Objective To verify the performance of calibrator with new batch number for automatic biochemi‐cal analysis systems (Cfas), using lactate dehydrogenase (LDH) as an example .Methods LDH of twenty serum samples were detected by Roche Cobas C501 automatic biochemical analyzer before and after replacement of calibrator with new batch number .The detection results were analyzed by Bland‐Altman analysis method and Medcalc 12 .7 .0 software .Results According to the Bland‐Altman scatter diagram, a total of 19 dots were within limits of agreement (LoA), accounting for more than 95% of all dots .The mean value of difference between the results of twice detection was only -0 .2 U/L, which was very closed to zero, and the maximum difference was 8 U/L .The largest comparabil‐ity deviation (2 .48% ) was less than the comparability standard deviation(2 .87% ), which was clinically acceptable . Conclusion The detectable results of LDH before and after replacement of calibrator with new batch number could be in accordance, indicating the performance of the calibrator with new batch numbe might be acceptable .