Blood Dyscrasia
Conditions
Brief summary
This study is designed to evaluate and verify the clinical accuracy of the InRhythm PT/INR system; a point-of-care, whole blood PT/INR measurement with a reference plasma based PT/INR using a laboratory reference instrument and reagent (Sysmex/lnnovin) calibrated to the WHO rTF09 reference standard.
Interventions
None listed
Sponsors
University of Rochester
Accriva Diagnostics
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
- All * The subjects must be \> 18 years of age. * The subjects must be willing and competent to sign an informed consent. * The subjects must be able to attend the clinic for one visit to donate one FS blood sample and one venous blood draw of approximately 10 cc.
Exclusion criteria
- All * The subject is unable to donate fingerstick and venous blood samples. * The subject has a history of clinically significant bleeding associated with incising the finger and/or the venipuncture. * The subject is enrolled in any other study that involves an investigational drug and/or device. Additional Inclusion Criteria - Therapeutic Group * The subject must require oral VKA anticoagulant therapy. * The patient must have been anticoagulated for at least three months prior to enrollment. Additional
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of INR measurements | 5 weeks |
Outcome results
None listed