Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, Korea.
Department of Laboratory Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Ann Lab Med. 2022 Mar 1;42(2):150-159. doi: 10.3343/alm.2022.42.2.150.
Results from laboratories using multiple instruments should be standardized or harmonized and comparability-verified for consistent quality control. We developed a simple frequent comparability verification methodology applicable to large healthcare centers using multiple clinical chemistry instruments from different manufacturers.
Comparability of five clinical chemistry instruments (Beckman Coulter AU5800, Abbott Architect Ci16000, two Siemens Vista 1500, and Ortho Vitros 5600) was evaluated from 2015 to 2019 for 12 clinical chemistry measurements. Pooled residual patient samples were used for weekly verifications. Results from any instrument exceeding the allowable verification range versus the results from the comparative instrument (AU5800) were reported to clinicians after being multiplied by conversion factors that were determined via a linear regression equation obtained from simplified comparison.
Over the five-year study period, 432 weekly inter-instrument comparability verification results were obtained. Approximately 58% of results were converted due to non-comparable verification. Expected average absolute percent bias and percentage of non-comparable results for non-converted and converted results after conversion action were much lower than those for data measured before conversion action. The inter-instrument CV for both non-converted and converted results after conversion action was much lower than that for measured data before conversion action for all analytes.
We maintained within-laboratory comparability of clinical chemistry tests from multiple instruments for five years using frequent low-labor periodic comparability verification methods from pooled residual sera. This methodology is applicable to large testing facilities using multiple instruments.
来自使用多种仪器的实验室的结果应进行标准化或协调，并进行可比性验证，以确保一致的质量控制。我们开发了一种简单的频繁可比性验证方法，适用于使用来自不同制造商的多种临床化学仪器的大型医疗中心。
从 2015 年到 2019 年，对五台临床化学仪器（贝克曼库尔特 AU5800、雅培 Architect Ci16000、两台西门子 Vista 1500 和 Ortho Vitros 5600）进行了 12 项临床化学测量的可比性评估。使用混合的剩余患者样本进行每周验证。任何仪器的结果超出与比较仪器（AU5800）相比的允许验证范围的结果，在乘以通过简化比较获得的线性回归方程确定的转换因子后，报告给临床医生。
在五年的研究期间，获得了 432 个每周仪器间可比性验证结果。由于不可比验证，大约 58%的结果被转换。转换后非转换和转换结果的预期平均绝对百分比偏差和不可比结果的百分比均低于转换前测量数据的结果。转换后非转换和转换结果的仪器间 CV 均低于转换前测量数据的结果，对于所有分析物均如此。
我们使用来自混合剩余血清的频繁低劳动周期性可比性验证方法，在五年内维持了来自多种仪器的临床化学测试的实验室内可比性。这种方法适用于使用多种仪器的大型检测设施。
