Evaluating the consistency of prothrombin time results from two kinds of coagulation analyzers with EP9-A3 / 临床检验杂志

ABSTRACT

Objective@#To investigate the consistency of plasma prothrombin time (PT) results detected by the STAGO STA-R Evolution and Mindray Precil C3510 automatic coagulation analyzers. @*Methods@#The PTs from 69 plasma samples were detected by the STA-R Evolution and Precil C3510 coagulation analyzers, respectively, and the obtained results were compared. Based on the CLSI EP9-A3 protocol, the ESD test was used to detect outliers, the scatter plot, difference plot, and frequency distribution plot were drawn, and the method comparison and bias evaluation were performed using the Passing-Bablok regression and Bland-Altman plot. @*Results@#The PTs (median \[P 25, P 75\]) detected by the STA-R Evolution and Precil C3510 analyzers were 19.00 (13.85, 25.65) s and 20.50 (13.83, 26.30) s, respectively, and there was no significant difference between them (P＞0.05). No outliers were detected by the ESD test, and the variation of PTs (CV) was constant. There were no systematic, random and proportional differences in PT results from two coagulation analyzers. The bias between two coagulation analyzers was within the acceptable range (1/2 CLIA′88 TEa). The predicted bias of PT at each medical decision point was also within the acceptable range. @*Conclusion@#The results of PT detected by the Precil C3510 and STA-R Evolution coagulation analyzers are comparable, and the bias is within the acceptable range, which can meet the needs of clinical diagnosis and treatment.