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This is a multi-center study designed to evaluate the accuracy and precision of the INRatio® Prothrombin Time (PT) Monitoring System, utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, when used by trained medical professionals for the quantitative determination of PT and International Normalized Ratio (INR) in fingerstick and venous whole blood from subjects on oral anticoagulation therapy (OAT). These results will be compared to those PT/INR results obtained on plasma from the same subjects as analyzed at a central laboratory with the Sysmex CA-560 System.
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| Measure | Description | Time Frame |
|---|---|---|
| Analytical accuracy and precision of the INRatio Prothrombin Time (PT) Monitoring System. | 3-6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Approximately 210 subjects on OAT and 20 normal healthy subjects not on anticoagulation therapy will be enrolled.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda VA Hospital | Loma Linda | California | 92357 | United States | ||
| UC Davis Healthcare System |
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Plasma specimens for reference testing.
| Sacramento |
| California |
| 95817 |
| United States |
| San Diego Cardiac Center | San Diego | California | 92123 | United States |
| Fox Valley Cardiology | Aurora | Illinois | 60504 | United States |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D001281 | Atrial Fibrillation |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013927 | Thrombosis |
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