Tbit System Precision and Correlation of Different Blood Samples

Study Overview
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Brief Summary
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The Tbit™ System will detect S100B and GFAP concentrations with the blood specimen to produce and compare repeated measures from 3 blood samples from 3 fingersticks from one subject and one 1 venous whole blood sample will be collected from the same subject, on 3 different Tbit™ System by 3 different operators.

Official Title
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A Prospective, Multi-Center, Blood Collection Study to Evaluate TbitTM System Precision and Correlation Between Different Blood Samples Measured With TbitTM System

Conditions
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Brain Injuries, Traumatic Brain Injury

Intervention / Treatment
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* Diagnostic Test: Single Group Assignment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Presents to the Emergency Department with suspected traumatic brain injury Blood sample collected for Tbit™ System within 12 hours of injury Willing and able to provide informed consent or obtain consent from legal authorized representative (LAR) Exclusion Criteria: Suspect of ischemic or hemorrhagic stroke with subsequent incidental trauma based on ED examination Subject suspect of need of craniotomy for the acute trauma for this event External signs compatible with a depressed skull fracture based on ED exam Subject requiring administration of blood transfusion after injury and prior to study blood draw Subject for whom timing of injury is unable to be estimated within 1 hour of certainty Subject who had neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizures, brain tumors, stroke or TIA within the last 30 days, or history of neurosurgery Known or suspected to be pregnant Prisoner or under incarceration Participating in another clinical research study prior to this study completion

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Group Assignment<br> | Diagnostic Test: Single Group Assignment<br>* Tbit™ System will detect S100B and GFAP concentrations with the blood specimen collected<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement Repeatability | 1. Evaluate the repeatability of measurement of S100B and GFAP concentrations in capillary blood using the Tbit™ System at different clinical sites and between-instrument and between-operator components of variance in the intended use environment. | within 12 hours from injury for Tbit and within 30 min from the sample drawn | 
| Compare Measurements | 2. Compare concentrations of S100B and GFAP measured using Tbit™ System in specimens obtained from a fingerstick blood, venous whole blood, serum and plasma in the intended use environment. | within 12 hours from injury |