Performance Evaluation of the Coapresta®2000 Automated Coagulation analyzer for Screening Coagulogram

Objective: The Coapresta®2000 (CP) is an automated analyzer which can perform various coagulation assays. The author aimed to validate the CP performance for screening coagulogram testing, including APTT, PT, and fibrinogen assays, under our local situation such that the data could be applied to the laboratory in Thailand. Methods: The real patients’ samples and control materials were used to evaluate the CP in terms of precision, reference range, comparability to the validated analyzer Sysmex® CS-2100i (CS), carryover, and turnaround time. Results: The highest percentages of coefficient of variation of APTT, PT, and fibrinogen were 1.05, 3.92 and 2.53 for within run and 2.15, 2.71 and 6.53 for between run precision studies. The correlation coefficient of PT and fibrinogen between CP and CS were 0.99, while it was 0.77 for APTT. Considering warfarin dose adjustment, 6% of patients might require dose adjustment when using CP instead of CS. Carryover was not observed. The turnaround time of first specimen was less than 6 minutes for APTT and 3 minutes for PT and fibrinogen. Conclusion: The performance of CP for screening coagulogram in terms of precision and carryover was acceptable. The turnaround time was short. The comparability between CP and CS was excellent for PT and fibrinogen, but was fair for APTT. The participation of external quality assurance scheme is needed to assess the accuracy. Keywords: Coapresta®2000, automated analyzer, performance evaluation, screening coagulogra