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The Tbitâ„¢ 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 Tbitâ„¢ System by 3 different operators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Group Assignment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Group Assignment | Diagnostic Test | Tbitâ„¢ System will detect S100B and GFAP concentrations with the blood specimen collected |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement Repeatability | 1. Evaluate the repeatability of measurement of S100B and GFAP concentrations in capillary blood using the Tbitâ„¢ 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 Tbitâ„¢ System in specimens obtained from a fingerstick blood, venous whole blood, serum and plasma in the intended use environment. | within 12 hours from injury |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lelia A Paunescu, PhD | Contact | 7815268152 | apaunescu@medicept.com | |
| Travis Jones, BSc | Contact | 6783207670 | tjones@medicept.com |
| Name | Affiliation | Role |
|---|---|---|
| Jerika Acosta, BSc | Medicept Inc. | Study Director |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |