Clinical Evaluation of the Pre-Analytical Capabilities of Hemostasis Instrument.

Abstract

Objective: Evaluate the technical performance of the pre-analytical hemolysis-icterus-lipemia (HIL) check module on the ACL-TOP-750. Methods: 8433 routine coagulation samples were evaluated for HIL, the presence of clotting and low sample volume by both visual inspection and the pre-analytical HIL check module on the ACL-TOP-750. Results: 7726 samples were in agreement with both methods and 707 were not consistent. 356 samples with low volume were identified by visual inspection and 920 by the instrument (2.7 mL threshold). Visual inspection identified 56 lipemic samples while 13 of those with moderate or high lipemia were identified by the instrument. Visual inspection identified 47 hemolyzed samples while 7 with moderate or high hemolysis were identified by the instrument. Both visual inspection and the instrument identified 36 icteric samples. For triglyceride concentration and bilirubin concentration, there was good correlation between the ACL-TOP-750 and the DXC800 biochemistry analyzer. Among 30 samples with varying amounts of clotting, 27 were discovered by visual inspection and 3 were discovered by the instrument. Conclusion: The pre-analytical check module on the ACL-TOP-750 improved the detection rate of samples below the target 2.7 mL volume, and the accuracy in detection of HIL. However, the automated method could not replace visual assessment of clotting in samples.