Clinical evaluation of a microsample coagulation analyzer, and comparison with existing techniques

Area of Science:

• Clinical Pathology
• Medical Diagnostics
• Hematology

Background:

• Coagulation monitoring is crucial in interventional cardiology.
• Existing methods for activated clotting time (ACT) and activated partial thromboplastin time (aPTT) can be time-consuming.
• A novel microsample analyzer, the Hemochron Jr., has been developed for rapid coagulation testing.

Purpose of the Study:

• To evaluate the performance of the Hemochron Jr. analyzer in measuring ACT and aPTT.
• To compare Hemochron Jr. results with established laboratory methods.
• To assess the speed and reproducibility of the Hemochron Jr. during coronary interventions.

Main Methods:

• The Hemochron Jr. uses a 5-microliter whole-blood sample and an optical detector.
• Results are extrapolated to ACT and aPTT values using validated regression analysis.
• Simultaneous ACT+ and Hemochron ACT measurements were compared in 44 patients undergoing coronary intervention (n=124).
• Paired Hemochron Jr. aPTT and laboratory aPTT results were analyzed (n=53).

Main Results:

• Hemochron Jr. aPTT showed strong correlation with laboratory aPTT (r = .79, P < .0001).
• Hemochron Jr. provided significantly faster results than laboratory aPTT (3.5 min vs. 56.3 min, P = 0.0029).
• ACT+ measurements demonstrated high reproducibility.
• Hemochron ACT correlated well with ACT+ (r = .85, P < .0001), with slight but significant differences observed at baseline and after heparin administration.

Conclusions:

• The Hemochron Jr. offers a fast, reproducible, and accurate method for point-of-care coagulation testing.
• Its ability to use small blood volumes is advantageous.
• Further research is needed to establish optimal anticoagulation ranges for the Hemochron Jr. in interventional procedures.