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The George King Coumadin® Plasma is an assayed control plasma derived from a single donor on Coumadin® therapy and is intended for in vitro diagnostic use in monitoring the accuracy of the coagulation analyzer and thromboplastin using the clottable prothrombin time/INR on an optical instrument with appropriate commercial reagents. George King Coumadin® Plasma may be used when evaluating a new lot of thromboplastin reagent or new coagulation analyzer.

Each lot of George King Coumadin® Plasma is from a single human donor stabilized on at least 6-weeks of Coumadin® therapy. The donor plasma is obtained via plasmapheresis using 4.0% sodium citrate and frozen immediately at -70°C. The INR of the donor plasma is determined using the ACL Top 500 using RecombiPlastin 2G and each plasma is then categorized into one of the three INR levels of control material based on the testing results obtained using the following INR calculation: INR = (Patient PT / Mean of normal range) ISI. Level 1 - INR Control: 1.5-2.8 Level 2 - INR Control: 2.9-4.0 Level 3 - INR Control: >4.0