Zou Zhenzhen, Tang Honghui, Xiao Erya, Zhou Yu, Yin Xuebei, Hu Zhen, Cai Yang, Han Qingzhen, Wang Lin
Center of Clinical Laboratory, The Fourth Affiliated of Soochow University, Suzhou, Jiangsu, 215000, China.
Suzhou Affiliated Hospital of Nanjing Medical University, Suzhou Municipal Hospital, Suzhou, Jiangsu, 215000, China.
Cell Biochem Biophys. 2025 Jun;83(2):1575-1591. doi: 10.1007/s12013-024-01568-3. Epub 2024 Oct 17.
This study aimed to evaluate the performance and clinical laboratory adaptability of the Mindray SAL9000 biochemical immunoassay automation system, ensuring compliance with ISO 15189 standards and relevant national requirements. We conducted comprehensive performance verification tests on 21 biochemical analytes and 15 immunoassays, including precision, accuracy, linear bias, measurement range assessments, interference testing, reference range validation, inter-instrument comparison, and carryover verification. The Mindray SAL9000 demonstrated high performance across various parameters, with all analytes showing good linearity and minimal bias. While specific interfering substances affected some analytes, the system showed excellent resistance to common interferences such as hemolysis, ascorbic acid, and jaundice. The inter-instrument comparison with the BS2000M and Roche 702 indicated a good correlation, with most parameters showing biases of less than 10%, although exceptions were noted for ALT and AST. In conclusion, the Mindray SAL9000 meets clinical requirements through its high precision, excellent accuracy, and broad measurement range, making it a reliable and adaptable choice for clinical outpatient and emergency laboratories.
本研究旨在评估迈瑞SAL9000生化免疫分析自动化系统的性能及临床实验室适应性，确保其符合ISO 15189标准及相关国家要求。我们对21种生化分析物和15种免疫分析进行了全面的性能验证测试，包括精密度、准确度、线性偏差、测量范围评估、干扰测试、参考范围验证、仪器间比对以及携带污染验证。迈瑞SAL9000在各项参数上均表现出高性能，所有分析物均显示出良好的线性和最小偏差。虽然特定干扰物质会影响某些分析物，但该系统对溶血、抗坏血酸和黄疸等常见干扰具有出色的抗性。与BS2000M和罗氏702的仪器间比对显示出良好的相关性，大多数参数的偏差小于10%，不过谷丙转氨酶（ALT）和谷草转氨酶（AST）存在例外情况。总之，迈瑞SAL9000凭借其高精度、出色的准确度和宽广的测量范围满足了临床需求，使其成为临床门诊和急诊实验室可靠且适用的选择。
