Fresh Intravenous Blood Samples for TBI Diagnostic Assay Development With Philips Point of Care System

Fresh Intravenous Blood Samples for TBI Diagnostic Assay Development With Philips Point of Care System (FIRST DOWN)

The purpose of this study is to collect fresh whole blood within 12 hours from suspected mild head injury (Glasgow Coma Scale score 13-15) from subjects over the age of 18, to help verify that both UCH-L1 and GFAP can be detected with the Philips Minicare POC diagnostic test platform.

Inclusion Criteria:

• The Subject is at least 18 years of age at screening.
• The Subject has presented to a Health Care Facility or Emergency Department with a suspected traumatically induced head injury, as a result of insult to the head from an external force.
• The Subject has a Glasgow Coma Scale score of 13-15 at the time of Informed Consent.
• The venous blood sample is collected no later than 12 hours from the time of head injury.
• The Subject is competent and willing to undergo the Informed Consent process

Exclusion Criteria:

• Participating in any other interventional, therapeutic clinical study (an observational study would be acceptable).
• Time of suspected head injury cannot be determined.
• Venipuncture not feasible (i.e., skin integrity compromised at the venipuncture sites, blood vessel calcification (i.e., IV drug users, advanced atherosclerosis) both upper limbs missing (congenital or amputee)).
• Blood transfusion after head injury, and prior to study blood draw
• Blood donation within 1 week of study enrollment.
• The subject is a female who is pregnant or lactating.
• The Subject is otherwise determined by the Principal Investigator to be an unsuitable candidate for participation