Ensuring Clinical Excellence: The Mindray SAL9000 Biochemical Immunoassay System.

Abstract

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.