Analytical Performance of the Biosino Urea Reagent Kit

Two kinds of analytical system are used to analyze urea concentration, one is the homogeneous ana- lytical system and the other is the heterogeneous analytical system. No matter which analytical systems are used, their performance characteristics must be evaluated. Here, the performance of a heterogeneous analytical system is evaluated.The UV urease-glutamate dehydrogenase (GLDH) reference method was reproduced and its accuracy and precision were verified. The performance characteristics of the Biosino urea reagent kit were evaluated ac- cording to the Clinical and Laboratory Standards Institute (CLSI) EP15-A2, EP6-A, and EP9-A2 guidelines.The performance characteristics of the UV urease-GLDH reference method demonstrate that the urea concentrations of the standard reference material (SRM) 909b I and II are within their prescriptive ranges, the within-run CVs are 0.39% and 0.16%, and the within-laboratory CVs are 0.63% and 0.40%, respectively. The performance characteristics of the Biosino urea reagent kit demonstrate that the within-run CVs are 0.84% and 0.78%, the within-laboratory CVs are 2.26% and 0.92%, the ranges of interference are 0-2.84% (0-1 g/L vitamin C), 0 - -2.86% (0-10 g/L intralipid), 0-2.81% (0-10 g/L hemoglobin), 0 - -2.1% (0-0.4 g/L conjugated bilirubin), 0 - -2.1% (0-0.4 g/L unconjugated bilirubin), and the analytical results are linear within the range of 1.8- 35.0 mmol/L. The analytical results of the Biosino urea analytical method and UV urease-GLDH, Olympus and Beckman urea analytical methods are strongly correlated (r > 0.998; p < 0.001), and the predicted biases are con- sidered acceptable at the three medical decision levels for urea.The Biosino urea reagent kit can provide reliable analytical results and the results are suitable for clinical uses.