PT/INR Reference Interval IN Healthy Volunteers

Study Overview
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Brief Summary
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This is a prospective, single-center study in healthy volunteers to establish a PT/INR reference interval for the Microvisk International Normalized Ratio (INR) Test System. The primary objective of this study is to establish the reference interval for the measurement of prothrombin time (PT/INR) using the Microvisk INR Test System. The second objective is to evaluate the safety of the device.

Detailed Description
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Healthy volunteers who meet eligibility criteria, have been fully informed and provided written informed consent will be enrolled into this study. Each participant will be required to donate up to 3 finger stick samples for testing on one occasion. The maximum trial duration for each participant is one visit/occasion. This will be followed by a standard venipuncture for (1) a neutral tube (Red Top) for analysis by the on-test method, (1) one sodium citrate tube (Blue Top) for analysis by the comparative/reference laboratory method. Sample collection will take place within the clinic session. The maximum trial duration for each participant is one clinic session.

Official Title
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A Prospective, Single-Center Study, in Healthy Volunteers to Establish a PT/INR Reference Interval for the Microvisk INR Test System

Conditions
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Healthy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is considered a healthy volunteer Subject is male or female, over 18 years of age Subject is informed and has been given ample time and opportunity to think about his/her participation and has given his/her written informed consent Subject agrees to have blood drawn (venipuncture) and finger stick Exclusion Criteria: Subject is unable to give informed consent Subject is less than 18 years of age Female subject is pregnant Subject is on anticoagulant medication or other medication known to affect PT/INR assessment (e.g., warfarin, heparin) for a minimum of 28 days before enrolling in the trial Subject has a medical condition known to affect PT/INR (e.g. vitamin K deficiency, disseminated intravascular coagulation, liver disease, decreased or defective factor I, II, V, VII, or X) Subject has already taken part in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| INR value for normal population | Establish the INR value for the normal population | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Number of Participants with Adverse Events) | Number of Participants with Adverse Events as a Measure of Safety | 1 day | 
| Device Failure (number of device failures) | Overall number of device failures to measure the robustness of system | up to 12 weeks |