Validation of a new whole blood coagulation monitoring system.
The Hemochron Response is a third generation point-of-care (POC) whole blood coagulation analyzer that retains the clinical utility of the Hemochron standard (801/8000) while providing a data management program that assists the POC coordinator with Quality Assurance (QA) compliance. Clinical and laboratory studies were performed to ensure consistency of the target anticoagulation times with the Hemochron standard and to evaluate precision and reproducibility of the Hemochron Response. Clinical tests for prothrombin time (PT) using fresh and citrated whole blood, activated clotting time (ACT), and activated partial thromboplastin time (APTT) showed excellent correlation to the Hemochron standard where r = 0.929, r = 0.969, r = 0.947, and r = 0.992, respectively. This was confirmed by a paired Student's t-test. The standard expectation for reproducibility of ACT tests has been a coefficient of variation (CV) of 10%. Laboratory studies of reproducibility and precision for the Response instrument included analysis of the CV using ACT test tubes. For normal and abnormal control plasma (CPL), the range of CVs observed was 3.3%-4.6% and 3.0%-5.0%, respectively. For heparin dose response analysis, the range for Donor 1 and 2 was 1.0%-4.2% and 1.1%-8.0%, respectively. These data suggest that the Hemochron Response is reliable and equivalent to the Hemochron standard in clinical applications.
Jaryno
Stacy
S
Clinical Research, Internacional Technidyne Corporation, Edison, New Jersey, USA. sjaryno@itcmed.com
Bennett
Kim
K
Loder
Carol
C
Zucker
Marcia L
ML
Pan
Chi-Miau
CM
LaDuca
Frank M
FM
D001322:Autoanalysis; D001777:Blood Coagulation; D006493:Heparin / Q000008:administration & dosage; D006801:Humans; D008991:Monitoring, Physiologic / Q000295:instrumentation*; D019095:Point-of-Care Systems; D011785:Quality Assurance, Health Care; D014481:United States
D006493:Heparin