Validation of the Hemochron Jr. Signature + Microcoagulation System and the Hemochron Configuration Manager

Abstract

The Hemochron Jr. Signature + is a point-of-care (POC) coagulation device that incorporates data and quality management features most often cited by health care professionals as crucial. The Hemochron Signature + and the Hemochron Configuration Manager software were evaluated at multiple sites to assess the system's clinical utility. Clinical and laboratory evaluations were performed to ensure consistency of the target anticoagulation times with the predicate Hemochron Jr. Signature. Tests for prothrombin time and activated clotting time showed excellent correlation to the Hemochron Jr. Signature (r = 0.912 and r = 0.972 respectively). After validation testing was complete, the operators at each site completed a questionnaire ranking the Signature + operational features. Electronic and liquid quality control lockout and operator and patient identification requirements were the most desirable features. Participants at all sites noted that the data management features of the Signature + would improve regulatory compliance substantially in the POC setting. Overall, the clinical operators reported the Signature + and Hemochron Configuration Manager to be an exciting, innovative technology ideally suited for managing the expanding scope of POC testing in health care.