PT/INR Reference Interval IN Healthy Volunteers
PT/INR Reference Interval IN Healthy Volunteers
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.
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.
Inclusion Criteria:

 1. Subject is considered a healthy volunteer

 2. Subject is male or female, over 18 years of age

 3. 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

 4. Subject agrees to have blood drawn (venipuncture) and finger stick

 Exclusion Criteria:

 1. Subject is unable to give informed consent

 2. Subject is less than 18 years of age

 3. Female subject is pregnant

 4. 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

 5. 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)

 6. Subject has already taken part in the study