Methods, systems, and a kit for diagnosis, detection, monitoring and treatment of traumatic brain injury
AssigneeRapidDx, Inc.
InventorsBalwant Rai, Jasdeep Kaur
Life of this patent
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Abstract
Methods and systems for diagnosis, detection, monitoring, and treatment of traumatic brain injury are described. The methods and systems include detection of salivary biomarkers associated with brain injury in a human subject, one application of which is to determine whether the subject has sustained a concussion or a more severe traumatic brain injury (TBI). Detection of the salivary biomarkers can also provide a basis to determine that a subject can safely return to play in an athletic event and can provide a basis to evaluate the efficacy of particular treatments. The methods and systems may be implemented, for example, by means of a kit.
Claims35
A system for detecting traumatic brain injury (TBI) of at least mild severity (mTBI) in a human subject, comprising:
- (a) at least one binding agent specific to a Ubiquitin Carboxy-Terminal Hydrolase L1 (UCH-L1) biomarker or UCH-L1 in combination with one or more biomarker selected from the group consisting of Neuron Specific Enolase (NSE), Glial Fibrillary Acidic Protein (GFAP), and Interleukin 8 (IL-8);
- (b) a measurable label that indicates a proportional reaction based on the level of biomarker present in a saliva sample from the subject;
- and
- (c) a measurement device operable to provide a visible indication of the measurable label to provide a qualitative or quantitative level of one or more biomarkers in the saliva sample indicative that the subject has TBI,
- wherein the system detects when the one or more biomarkers are at the following concentrations in the saliva sample and such detection is indicative that the subject should be evaluated for possible TBI:
- (i) NSE concentrations of between 0.8 pg/ml and 2.1 pg/ml;
- (ii) GFAP concentrations of between 0.7 pg/ml and 2.5 pg/ml;
- (iii) UCH-L1 concentrations of between 0.8 pg/ml and 65 pg/ml;
- and
- (iv) IL-8 concentrations of between 450 pg/ml and 950 pg/ml.
A system for detection of possible mild traumatic brain injury (mTBI) or more severe traumatic brain injury (TBI) in a human subject within 6 hours after a head injury event, the system comprising:
- (a) at least one binding agent specific to a Ubiquitin Carboxy-Terminal Hydrolase L1 (UCH-L1) biomarker or UCH-L1 in combination with one or more biomarker, the one or more biomarker being selected from the group consisting of Neuron Specific Enolase (NSE), Glial Fibrillary Acidic Protein (GFAP), and Interleukin 8 (IL-8);
- (b) a measurable label that indicates a proportional reaction based on the level of biomarker present in a saliva sample from the subject;
- and
- (c) a measurement device which provides a visible indication of the measurable label when the one or more biomarker in the subject's saliva sample is at or above the following concentrations:
- (i) NSE at or above about 1 pg/ml;
- (ii) GFAP at or above of about 1 pg/ml;
- (iii) UCH-L1 at or above about 10 pg/ml;
- and
- (iv) IL-8 at or above about 400 pg/ml,
- whereby, appearance of the indication means that the subject should be evaluated for possible mTBI or TBI.
Dependencies are inferred from the claim text.