QStat Pilot Reference Range Study

Study Overview
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Brief Summary
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The objective is to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge.

Detailed Description
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This is a single center prospective, observational study of a healthy adult population with normal coagulation function to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge. The threshold for the Clot Stability to Lysis (CSL) parameter will be determined from the CSL reference range.

Official Title
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Reference Range Pilot Study for the Quantra Analyzer With the QStat Cartridge

Conditions
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Coagulation Disorder

Intervention / Treatment
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* Diagnostic Test: Quantra System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 years or older Subject is willing to participate and has signed a consent form Subject's laboratory coagulation test results at screening are within each test's normal reference range. Exclusion Criteria: Subject is younger than 18 years Subject has a history of a coagulation disorder Subject is pregnant or lactating Subject is currently taking medications known to alter coagulation Subject has one or more laboratory coagulation test restuls outside of the normal reference range at screening Subject had a blood transfusion or surgery within the last month Drug abuse Excessive alcohol consumption Subject is unable to provide written informed consent Subject is incarcerated at the time of the study Subject previously participated in this 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy volunteers<br>Blood samples from healthy volunteers analyzed on the Quantra System | Diagnostic Test: Quantra System<br>* Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.<br>* Other names: QStat Cartridge;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reference range intervals for measurement of Clot Time (CT) parameter | Reference range intervals determined in this study will serve as the reference range for CT on the QStat Cartridge when it is commercially available. | Baseline, determined from a single blood draw | 
| Reference range intervals for measurement of Clot Stiffness (CS) parameter | Reference range intervals determined in this study will serve as the reference range for CS on the QStat Cartridge when it is commercially available. | Baseline, determined from a single blood draw | 
| Reference range intervals for measurement of Fibrinogen Contribution to Clot Stiffness (FCS) parameter | Reference range intervals determined in this study will serve as the reference range for FCS on the QStat Cartridge when it is commercially available. | Baseline, determined from a single blood draw | 
| Reference range intervals for measurement of Platelet Contribution to Clot Stiffness (PCS) parameter | Reference range intervals determined in this study will serve as the reference range for PCS on the QStat Cartridge when it is commercially available. | Baseline, determined from a single blood draw | 
| Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter | Reference range intervals determined in this study will serve as the reference range for CSL on the QStat Cartridge when it is commercially available. | Baseline, determined from a single blood draw |