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This multi-center study is designed to evaluate the ability of intended lay users (patients on oral anticoagulation therapy, OAT, or their caregivers) to 1) operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, and 2) obtain accurate results for the quantitative determination of International Normalized Ratio (INR) when self-testing using fingerstick capillary blood. Patients will be trained by their healthcare provider using the instructions for use and product labeling provided. The accuracy of the patient INR results will be assessed by comparison to the INR results obtained by the site's trained healthcare professional using the same INRatio system (from a separate fingerstick collected from the same patient at the point-of-care), and with the INR results obtained on venous plasma obtained from the same patient and analyzed at a central laboratory with the Sysmex CA-560 System INR reference method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BSTE-0125-Original Protocol | |||
| BSTE-0125.a-Amended Protocol |
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| Measure | Description | Time Frame |
|---|---|---|
| Operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited from their primary care clinic.
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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 retained for reference method comparison.
| Sacramento |
| California |
| 95817 |
| United States |
| San Diego Cardiac Center | San Diego | California | 92123 | United States |
| Fox Valley Cardiology | Aurora | Illinois | 60504 | United States |