Evaluation and performance characteristics of the coagulation system: ACL TOP analyzer - HemosIL reagents

ACL TOP is a fully automated coagulation analyzer, designed for simultaneous measurement of routine and special coagulation parameters. We evaluated analytical and technical performance characteristics of the coagulation system composed of the ACL TOP analyzer and HemosIL reagent group for the determination of routine clotting (PT, APTT, fibrinogen, FVII, and FVIII), chromogenic (protein C) and immunological assays (FXIII antigen). Within run and between run CVs ranged from 0.9% to 7.7% and from 2.0% to 14.8% respectively. The obtained CVs for imprecision of calibration curves were <5% of PT and <7% for fibrinogen. The method comparison study showed good correlation between results obtained on the ACL TOP and BCS/BCT analyzers, with correlation co-efficients ranging from 0.709 to 0.955, but with significantly different results for PT INR, APTT, fibrinogen and protein C, and wide dispersion of differences observed in difference plots for most assays. Despite good correlation and agreement for FVIII, problems in measuring FVIII<10% were encountered. The effective througput for the ACL TOP and BCS was 151 and 212 PT/APTT/fibrinogen tests per hour, respectively. Although the ACL TOP is designed to run multiple assays on a large number of samples, software limitations make the instrument suitable rather for mid-sized laboratories.