两份分析仪（Cobas 6000（c501）和 Cobas Integra 400 Plus）的部分临床化学检验结果比较。
Comparison of Selected Clinical Chemistry Assay Results by two Analyzers: Cobas 6000 (c501) and Cobas Integra 400 Plus.
出版信息
Clin Lab. 2022 May 1;68(5). doi: 10.7754/Clin.Lab.2021.210734.
BACKGROUND
Comparison of assay results is very important for having a comparable backup analyzer to provide a quality laboratory service without interruption. Even though, several factors affect assay results by different instruments, little or no data is available regarding assay results comparison between Cobas 6000 (c501) and Cobas integra 400 plus in the study area. Thus, the present study was aimed to compare assay results of two fully auto-mated clinical chemistry analyzers: Cobas 6000 (c501) and Cobas Integra 400 Plus at the National Clinical Chemistry Reference Laboratory of Ethiopian Public Health Institute, Addis Ababa, Ethiopia.
METHODS
The assay results for the 20 selected clinical chemistry parameters were obtained from 52 randomly selected samples on Cobas 6000 (c501) and Cobas integra 400 plus. Statistical analysis was done using Med-Calc software. The 2019 CLIA proposed acceptance limits for proficiency testing were used to check bias or difference obtained from correlation and regression analysis.
RESULTS
Assay results comparison revealed almost perfect data correlations among all selected clinical chemistry parameters: Albumin, ALP, ALT, Alpha-amylase (AMYL), AST, Direct bilirubin, Total bilirubin, Total cholesterol, Creatine kinase, Creatine kinase MB-subunit, Creatinine, GGT, Glucose, HDLC4, LDH, Phosphate, Total Protein, Triglycerides, Uric acid, and Urea, on both analyzers with coefficient of determination (R2) ranging from 98.9% to 99.99% and coefficient of correlation (r) ranging from 99.4% to 100%, depicting the precision and reliability of assay results, standardization, and system equivalency. Moreover, the calculated bias/difference is lower than both CLIA total allowable error and CLIA allowable error.
CONCLUSIONS
In summary, regression/correlation analysis and calculated bias or difference revealed almost equivalent data representation of both analyzers as per the CLIA standard, thus showing that both fully automated analyzers are standardized and properly calibrated to be used simultaneously and inter-changeably as the main and back up analyzers for selected clinical chemistry parameters analyzed at the clinical chemistry reference laboratory.
背景
比较检测结果非常重要，因为拥有可比的备用分析仪可以在不中断的情况下提供高质量的实验室服务。尽管不同仪器的检测结果会受到多种因素的影响，但在研究区域内，关于 Cobas 6000（c501）和 Cobas integra 400 plus 之间检测结果比较的数据很少或没有。因此，本研究旨在比较两个全自动临床化学分析仪的检测结果：Cobas 6000（c501）和 Cobas Integra 400 Plus 在埃塞俄比亚公共卫生研究所国家临床化学参考实验室。
方法
从 Cobas 6000（c501）和 Cobas integra 400 plus 上随机选择的 52 个样本中获得了 20 个选定的临床化学参数的检测结果。使用 Med-Calc 软件进行统计分析。使用 2019 年 CLIA 提出的熟练测试接受限值来检查相关性和回归分析中获得的偏差或差异。
结果
检测结果比较显示，所有选定的临床化学参数之间的数据相关性几乎是完美的：白蛋白、碱性磷酸酶（ALP）、丙氨酸氨基转移酶（ALT）、α-淀粉酶（AMYL）、天门冬氨酸氨基转移酶（AST）、直接胆红素、总胆红素、总胆固醇、肌酸激酶、肌酸激酶同工酶-MB 亚单位、肌酐、谷氨酰转移酶、葡萄糖、高密度脂蛋白胆固醇 4、乳酸脱氢酶、磷酸盐、总蛋白、甘油三酯、尿酸和尿素，两种分析仪的决定系数（R2）范围从 98.9%到 99.99%，相关系数（r）范围从 99.4%到 100%，这表明检测结果的精密度和可靠性、标准化和系统等效性。此外，计算出的偏差/差异低于 CLIA 总允许误差和 CLIA 允许误差。
结论
综上所述，回归/相关分析和计算出的偏差或差异表明，根据 CLIA 标准，两种分析仪的数据表示几乎相同，这表明这两种全自动分析仪已标准化，并经过适当校准，可以同时使用并相互替换，作为临床化学参考实验室分析的选定临床化学参数的主用和备用分析仪。
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