Abstract:

Objective　 To evaluate the main performance parameters of Destiny Max automatic coagulation analyzer (Destiny Max analyzer). Methods　 According to the Clinical and Laboratory Standards Institute (CLSI) document, the precision, detection limit, linearity, contamination rate and stability of Destiny Max analyzer were evaluated, and the results were compared with those by Stago STA-R coagulation system (Stago STA-R analyzer). The evaluation parameters included prothrombin time (PT), international standardization ratio (INR), activated partial thromboplastin time (APTT), thrombin time (TT) and fibrinogen (FIB). Results 　The within-run coefficients of variation (CV) of all the results detected by Destiny Max analyzer were <3%,and the between-run CV were <1/3 total error. The detection limit of FIB was 0.50 g/L, and it had good linearity in the range of 0.90-8.97 g/L. The results of contamination rate were less than 1/4 of total error. The results were stable within 15 d after open vial reconstituted. The CV of all the results were <10%. The correlation of Destiny Max analyzer, and Stago STA-R analyzer showed that except the coefficient of correlation (r²) of APTT was 0.813 4,the results of PT,INR and FIB were in high correlation(r²>0.95). Conclusions　 The precision, linearity, detection limit and contamination rate of Destiny Max analyzer meet the requirements. The stability of reagents and performance of Destiny Max analyzer are quite good and suitable for the clinical application.

Key words: Performance evaluation, Automatic coagulation analyzer, Detection limit, Linear range