Provider Frequently Asked Questions
Neural-Injury Assessment Test™ Complete Panel and Neural-Injury Assessment Test™ Biomarker Panel
Ordering the Test
Which tests are available?
Providers may order:
Neural-Injury Assessment Test™ Complete Panel
Neural-Injury Assessment Test™ Biomarker Panel
The Complete Panel includes protein biomarkers and genetic markers. Genetic markers only need to be evaluated once because an individual's genetic profile remains unchanged over time.
The Biomarker Panel includes protein biomarkers only.
How do I order the Neural-Injury Assessment Test™?
Providers submit test orders through the Brazos Neuroscience Provider Portal.
Is a requisition form required?
Yes. Providers must complete and submit the Brazos Neuroscience Test Requisition Form when placing a test order through the provider portal.
Incomplete requisition forms may delay scheduling or specimen processing.
Where can I access the requisition form?
The Test Requisition Form is available within the Provider Portal and should be completed at the time of test ordering.
What clinical situations may warrant testing?
The Neural-Injury Assessment Test™ may be considered when evaluating patients with:
• Concussions and traumatic brain injuries
• Motor vehicle accidents
• Falls
• Sports-related injuries
• Military blast exposures
• Occupational injuries
• Repetitive head impacts
• Heavy metal exposures
• Carbon monoxide exposure
• Neuroinflammatory conditions
• Neuroimmune activation
• Environmental neurotoxic exposures
Results should always be interpreted alongside clinical history, symptoms, physical examination findings, and other diagnostic evaluations.
Can the Neural-Injury Assessment Test™ be performed more than 30 days after an injury?
Yes. Scientific literature demonstrates that blood-based neurologic biomarkers may remain clinically relevant beyond the acute injury window and into the subacute and chronic phases of recovery. While some biomarkers peak acutely, others may remain elevated or demonstrate meaningful biologic patterns for weeks, months, or longer depending on injury severity, biologic processes, and individual recovery trajectories. In the subacute and chronic setting, biomarker testing may provide objective biologic context regarding ongoing injury-associated processes, including neuroinflammation, axonal injury, and tissue recovery, and may support longitudinal clinical monitoring when interpreted within the broader clinical context rather than in isolation.
Specimen Collection & Blood Draw Process
How is the test performed?
Testing is performed through a standard venous blood draw conducted by a trained phlebotomist. The required specimen consists of one EDTA tube and one sodium citrate tube collected through standard venipuncture.
What blood draw options are available?
Blood specimens may be collected through:
• In-office collection for providers who offer in-clinic phlebotomy services.
• Mobile phlebotomy services coordinated by Brazos Neuroscience.
• Outpatient collection centers coordinated by Brazos Neuroscience.
For providers who do not perform blood draws in their office, Brazos Neuroscience manages patient scheduling and collection coordination. Collection options may vary based on patient location and service availability.
Can providers collect specimens in their office?
Yes. Providers with in-office phlebotomy capabilities may collect specimens directly using the supplied collection kit.
What happens if the provider does not perform blood draws?
If in-office collection is unavailable, Brazos Neuroscience will coordinate mobile or outpatient collection services depending on patient location.
Does Brazos schedule blood collections?
Yes. When mobile or outpatient collection is required, the Brazos Patient Scheduling Team coordinates blood draw appointments directly with the patient.
Specimen Kits & Shipping
How are collection kits distributed?
For in-office collections, specimen kits are shipped directly to the provider's office.
For mobile or outpatient collections, kits are shipped directly to the patient.
Are special handling requirements required?
Yes. Cold packs should be frozen prior to collection according to kit instructions.
Specimens should be packaged and shipped according to the provided instructions to maintain specimen integrity.
What if a specimen requires recollection?
Occasionally, specimens may not meet laboratory acceptance criteria.
If recollection is necessary:
• Brazos Neuroscience will notify the provider and patient.
• A replacement kit may be issued.
• Collection will be rescheduled as appropriate.
How can I order bulk test kits?
Providers who offer in-clinic phlebotomy may request bulk test kits to maintain inventory within their practice. To order bulk test kits, please email [email protected]. The Brazos Neuroscience team will assist with coordinating inventory and shipment needs.
Results & Clinical Interpretation
When are results available?
Results are typically available within 7–10 business days after the laboratory receives the specimen.
How are results delivered?
Results are securely delivered to the ordering provider through the provider portal and a patient-facing report is sent to the patient’s email.
Does the test determine injury severity or timing?
No.
The Neural-Injury Assessment Test™ does not establish:
• Injury severity
• Timing of injury
• Mechanism of injury
Results should always be interpreted within the patient's clinical history and examination findings.
Protein Biomarkers
Which biomarkers are measured?
The panel includes:
GFAP (Glial Fibillary Acidic Protein)
UCH-L1 (Ubiquitin Terminal Hydrolase)
S100B (S100 Calcium-Binding Protein B)
NF-H (Neurofilament Heavy Chain)
What biological processes do these biomarkers evaluate?
The biomarkers provide objective biological data associated with:
• Neuronal injury
• Glial injury
• Axonal injury
• Blood-brain barrier disruption
• Neuroinflammation
• Neurotoxicity
• Cellular recovery processes
Are the biomarkers qualitative or quantitative?
Brazos Neuroscience provides quantitative measurements of each biomarker.
These measurements may assist providers in evaluating biological changes and monitoring trends over time.
How long may biomarkers remain elevated?
Biomarkers associated with brain injuries may change over time. Published studies have reported biomarker elevations persisting for varying lengths of time; however, no definitive timeline has been established across all biomarkers, patient populations, and testing platforms.
Healthcare providers should consider the timing of biomarker levels and trends over time when interpreting results within the appropriate clinical context. Additionally, this test does not establish injury severity or timing of a brain injury event.
Can biomarkers be monitored over time?
Yes. Many providers repeat testing approximately every three months to evaluate biomarker trends over time.
Serial measurements may assist with longitudinal assessment when interpreted alongside clinical findings.
Genetic Markers
Which genetic markers are included?
The Complete Panel includes:
APOE (Apolipoprotein E)
MTHFR (Methylenetetrahydrofolate Reductase)
Do genetic results need to be repeated?
No.
Genetic testing only needs to be performed once because an individual's DNA sequence does not change over time.
How should APOE and MTHFR findings be interpreted?
Genetic findings should not be interpreted in isolation.
Providers should consider:
• Clinical history
• Environmental factors
• Lifestyle factors
• Nutritional status
• Other diagnostic findings
These markers may provide insight into gene-environment interactions and neurological risk factors.
How do genetic variants provide additional clinical context?
Genetic variants are common alterations in the DNA sequence that may influence individual traits and health.
APOE and MTHFR genetic variants provide information about inherited factors that may influence cognitive function, neurological conditions, and individual responses to injury or disease.
Having a genetic variant alone does not mean an individual will develop or experience symptoms related to a specific condition. Genetic variants should never be assessed in isolation from other contributing factors, such as nutrition, environment, and overall health.
Healthcare providers may use genetic variant findings to better understand gene-environment interactions, assess potential risks, and identify lifestyle modifications to support patient care.
What is the APOE gene and how common is it to have an APOE ε4 allele?
The APOE gene encodes apolipoprotein E, a protein involved in lipid metabolism and the transport of cholesterol and other fats in the bloodstream.
APOE plays an important role in facilitating the repair and maintenance of neuronal membranes, promoting synaptic function, and supporting the overall health of brain cells.
Normal APOE function is important for communication between brain cells and may influence cognitive ability and memory.
The ε4 allele may be associated with impaired synaptic function and neuroinflammation, potentially contributing to cognitive changes over time.
The APOE ε4 allele is found in approximately 15–30% of people worldwide, depending on ethnicity and geographic region.
What health conditions are associated with the APOE ε4 allele?
Emerging scientific research indicates an association between the APOE ε4 allele and an increased risk of developing various mental health and neurological conditions, including but not limited to:
• Alzheimer's disease
• Lewy body dementia
• Cognitive impairment
• Increased neuroinflammation
• Anxiety
• Depression
What is the MTHFR gene and how common is it to have an MTHFR genetic variant?
The MTHFR gene encodes methylenetetrahydrofolate reductase, an enzyme that converts dietary folate (vitamin B9) into an active form called methylfolate.
The brain uses methylfolate for:
• DNA synthesis and repair
• Neurotransmitter production (e.g., serotonin, dopamine, norepinephrine)
• Methylation, a process that helps regulate genes and chromosomal structure
• Supporting myelin integrity to insulate nerve fibers
All of these functions are vital for optimal cognitive function.
Certain genetic variants of the MTHFR gene may reduce enzyme activity and impair folate metabolism. This may be associated with elevated homocysteine levels and reduced availability of methylfolate, potentially influencing cognition and mood.
MTHFR genetic variants are very common, with at least one copy of either the rs1801133 or rs1801131 variant found in approximately 60–70% of people worldwide, depending on ethnicity and geographic region.
What health conditions are associated with MTHFR genetic variants?
Emerging scientific research indicates an association between MTHFR genetic variants and an increased risk of developing various mental health and neurological conditions, including but not limited to:
• Alzheimer's disease
• Cognitive impairment
• Depression
Do the genetic markers need to be tested more than once?
No. Genetic markers only need to be tested once because DNA does not change over time.
Laboratory & Scientific Information
What quality standards does the laboratory follow?
The Neural-Injury Assessment Test™ is performed in a:
Clinical Laboratory Improvement Amendments (CLIA) certified laboratory
College of American Pathologists (CAP) accredited laboratory
What are the analytical performance characteristics?
The Neural-Injury Assessment Test™ demonstrates:
99% sensitivity
93% specificity
Is the test intended to be used independently?
No.
The Neural-Injury Assessment Test™ is intended to complement:
• Clinical evaluation
• Patient history
• Physical examination
• Imaging studies
• Neurocognitive assessments
• Other diagnostic evaluations
Results should always be interpreted within the appropriate clinical context.
Laboratory Quality & Validation
What quality standards does Brazos Neuroscience’s laboratory follow?
The Neural-Injury Assessment Test™ is performed in a CLIA (Clinical Laboratory Improvement Amendments) -certified and CAP-accredited laboratory. The biomarkers included in the test are supported by a growing body of scientific literature and research related to traumatic brain injury, neurotoxicity, neuroinflammation, and neurological function.
What does it mean that Brazos Neuroscience is a CLIA-certified and CAP-accredited laboratory?
Brazos Neuroscience is a Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited clinical laboratory. These certifications require the laboratory to meet rigorous federal and industry standards for quality, accuracy, reliability, and ongoing quality assurance.
As part of Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) requirements, the laboratory validates its testing methods, maintains comprehensive quality control procedures, participates in proficiency testing, and undergoes routine inspections to ensure testing continues to meet established performance standards.
These certifications help ensure that laboratory testing is performed in a controlled, highly regulated environment using validated analytical methods.
What is the difference between an FDA-approved test and a Laboratory Developed Test (LDT)?
U.S. Food and Drug Administration (FDA) approval and Clinical Laboratory Improvement Amendments (CLIA) validation serve different regulatory purposes and should not be conflated.
The FDA regulates commercially manufactured diagnostic devices and test kits. In contrast, CLIA and the College of American Pathologists (CAP) regulate how clinical laboratories develop, validate, perform, and maintain laboratory testing.
The Neural-Injury Assessment Test™ is a Laboratory Developed Test (LDT) performed exclusively within Brazos Neuroscience's CLIA-certified and CAP-accredited laboratory. Unlike commercially distributed FDA-cleared diagnostic kits, LDTs are analytically validated by the laboratory to demonstrate that they produce accurate, reliable, and reproducible results for their intended clinical use.
As part of this validation process, laboratories evaluate analytical performance characteristics such as accuracy, precision, reproducibility, reportable range, specimen stability, linearity, quality control, and potential sources of analytical interference. CLIA and CAP also require ongoing quality assurance, routine inspections, and proficiency testing to help ensure continued laboratory performance.
Importantly, FDA approval and CLIA/CAP validation represent different regulatory pathways.
With regard to LDT reporting, federal regulations require laboratories to include a statement indicating that the assay was developed by the laboratory, along with information describing the method and performance characteristics necessary for clinical use. Accordingly, reports for the Neural-Injury Assessment Test™ include the following required statement:
“This test was developed and its performance characteristics determined by Brazos Neuroscience. It has not been cleared or approved by the U.S. Food and Drug Administration.”
This statement reflects the distinct regulatory framework governing LDTs and should not be interpreted as an indication that the test is less scientifically rigorous or less reliable than an FDA-cleared or FDA-approved test. Rather, it reflects the regulatory pathway under which the test was developed, analytically validated, and is performed within a CLIA-certified and CAP-accredited laboratory.
Like all laboratory testing, Neural-Injury Assessment Test™ results should be interpreted by a healthcare provider alongside a patient's medical history, symptoms, physical examination, imaging, and other relevant clinical information.
Is the test efficacious?
The Neural-Injury Assessment Test™ is designed to objectively measure proteins associated with neurologic injury-related biologic processes, including astroglial injury, neuronal injury, axonal injury, neuroinflammation, and tissue recovery. Biomarkers such as GFAP, UCH-L1, S100B, and neurofilaments are analytically measurable and have been associated in the scientific literature with neurologic injury and recovery trajectories. Importantly, the test is not intended to function as a standalone diagnostic tool but rather as one component of a broader clinical evaluation interpreted alongside symptom presentation, history, imaging, examination findings, and other clinical data to provide objective biologic context.
Neuroendocrine Assessment Test (Coming Soon)
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