生化分析仪是利用光电比色法原理量化体液中特定化学成分的重要仪器。该分析为诊断提供了关键数据,治疗,预后,以及临床实践中各种疾病的总体健康状况。然而,生化分析仪的性能可能在不同品牌之间或在同一品牌内随时间而显著不同。因此,必须定期评估分析仪的性能,以确保纵向研究的结果一致,并保持日常数据的一致性。此外,当使用多个分析仪时,有必要评估每个仪器的性能,以确保跨多个平台的准确结果。在这项研究中,我们开发并验证了仪器分析性能的实验评估方案,生化分析仪的化学计量学,利用国家参考材料和患者血清作为实验对象。我们评估了光学系统的性能,温度控制系统,样品添加系统,和检测系统来证实该方案的可行性。我们还比较了不同品牌生化分析仪用于常规生化测试的分析性能,比如肝功能,肾功能,离子,血脂,血糖,和心肌酶谱。使用AU5400作为对照,使用ADVIA2400作为比较系统,在临床医学决策层面,仪器间比较数据的相对差异被认为是可接受的.总之,生化分析仪的性能可能在不同品牌之间或在同一品牌内随时间而显著不同。定期评估是必要的,以确保不同分析仪的准确和一致的结果。本研究为评价生化分析仪的分析性能提供了一种可行的方案,可用于保证实验室不同品牌自动化学分析仪结果的准确性和一致性。
Biochemical analyzers are vital instruments that utilize the principle of photoelectric colorimetry to quantify a specific chemical composition in body fluids. This analysis provides critical data for the diagnosis, treatment, prognosis, and overall health status of various diseases in clinical practice. However, the performance of a biochemical analyzer can vary significantly between different brands or over time within the same brand. Therefore, it is imperative to regularly assess the performance of the analyzer to ensure consistent results for longitudinal studies and to maintain day-to-day data consistency. Additionally, when multiple analyzers are utilized, it is necessary to evaluate the performance of each instrument to ensure accurate results across multiple platforms. In this study, we developed and verified an experimental evaluation scheme for the analytical performance of the instrument, chemometrics for biochemical analyzers, utilizing national reference materials and patient sera as the experimental subjects. We evaluated the performance of the optical system, temperature control system, sample-adding system, and detection system to confirm the feasibility of this scheme. We also compared the analytical performance of different brands of biochemical analyzers for routine biochemical tests, such as liver function, kidney function, ion, blood lipids, blood glucose, and myocardial enzyme spectrum. Using the AU 5400 as a control and the ADVIA 2400 as the comparison system, the relative variation in inter-instrument comparison data was found to be acceptable at the clinical medicine decision level. In conclusion, the performance of a biochemical analyzer can vary significantly between different brands or over time within the same brand. Regular evaluations are necessary to ensure accurate and consistent results across different analyzers. This study provides a feasible scheme for evaluating the analytical performance of biochemical analyzers that can be used to ensure the accuracy and consistency of the results of different brands of automatic chemical analyzers in the laboratory.