Abstract:

Objective To evaluate the determination quality of creatinine（Cr）,uric acid（UA） and urea（Urea） determinations in clinical laboratories,through analyzing the results of small molecule determination trueness verification in Shanghai,2016. Methods Remaining samples from clinical laboratories were collected,and high-level and low-level frozen mixed blood samples were prepared. These samples were determined repeatedly in different working days,and the results were returned through network. Reference methods were used to assignment simultaneously. Biases and coefficients of variation（CV） of the 3 parameters were obtained and analyzed according to different instrument systems. Results According to different instrument systems,the bias between Cr-2016A determination results and target value was -5.54%-0.62%,and that between Cr-2016B determination results and target value was -5.34%-2.89%. The bias between UA-2016A determination results and target value was -1.43%-2.62%,and that between UA-2016B determination results and target value was -1.49%-3.73%. The bias between Urea-2016A determination results and target value was -1.74%-0.81%,and that between Urea-2016B determination results and target value was -0.08%-1.16%. The performance was assessed according to the criterion listed in the analytical quality specification for routine analysis in clinical biochemistry （WS/T 403—2012） and the target value by reference methods. The failure ratios of Cr determination in high-level and low-level frozen mixed blood samples were 17.14% and 7.14%,the failure ratios of UA determination were 10.00% and 14.29%,and the failure ratios of Urea determination were 41.43% and 37.14%,respectively. Conclusions The accuracies of Cr and UA can meet related requirements in most clinical laboratories. However,the determination quality of Urea still should be improved.

Key words: Creatinine, Uric acid, Urea, Reference method, Trueness verification