Multicenter evaluation of analytical performance and onboard stability of Mindray 10 concentrated biochemical reagents

Objectives To systematically evaluate the analytical performance of 10 newly developed Mindray concentrated biochemical reagents (alanine aminotransferase concentrated reagent; ALTn, aspartate aminotransferase concentrated reagent; ASTn, albumin concentrated reagent; ALBn, total protein concentrated reagent; TPn, total bilirubin concentrated reagent; TBILn, direct bilirubin concentrated reagent; DBILn, glucose concentrated reagent; GLUn, carbon dioxide concentrated reagent; CO 2 n, urea concentrated reagent; UREAn, uric acid concentrated reagent; UAn) for routine clinical application in medium and large hospitals. Methods Method comparison was conducted in three clinical laboratories, while repeatability, precision, linearity, LoD, and onboard stability were evaluated at a single center Fu Xing Hospital, Capital Medical University (FXH-CMU (Fuxing Hospital, Capital Medical University). Method comparison was performed vs. Mindray non-concentrated, Roche, and Abbott reagents (per CLSI (Clinical and Laboratory Standards Institute) EP09-A3c). Results All 10 concentrated reagents exhibited excellent analytical performance: within-laboratory precision CV % ranged from 0.45 % to 3.00 %, with repeatability CV % below 2 %; all showed excellent linearity within clinically relevant concentration ranges, with R 2 (coefficient of determination) all exceeding 0.999. Limit of detection (LoD) values were lower than the claimed linear lower limits, and limit of blank (LoB) values were lower than LoD, meeting EP17-A2 requirements. method comparison revealed good agreement with all comparison systems: Passing-Bablok regression slopes were between 0.95 and 1.05, correlation coefficients (r) >0.995, mean biases at medical decision levels did not exceed ±4 %, and over 95 % of samples fell within Bland-Altman limits of agreement. CO 2 n, TPn, and UREAn maintained stable performance for 24 consecutive days after opening under standard instrument conditions (20–25 °C, 40–60 % humidity) without recalibration, with relative deviations ≤±4 %. Conclusions The newly developed Mindray concentrated reagents demonstrate excellent performance, meet laboratory quality requirements, reduce reagent replacement frequency, improve testing efficiency, and are well-suited for routine laboratory testing in medium and large hospitals.