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Biogen Program, Alzheimer Disease Evaluation, Spinal Fluid

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Test Code
PESOT/ESOT ADBIO


Alias/See Also
ABeta
Amyloid Beta 42
Beta-Amyloid 42
Phosphorylated Tau
pTau
Total Tau
tTau


CPT Codes
83520x3

Preferred Specimen
Alzheimer's Disease Evaluation (ADEVL) Collection Kit (T836)
2.0 mL CSF AD Biomarker Tube


Patient Preparation
For 12 hours before specimen collection do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.

Other Acceptable Specimens
Sarstedt 72.703.600 (1.5 mL) or Sarstedt 72.694.600 (2 mL)


Instructions
1. Perform lumbar puncture and discard the first 1 to 2 mL of cerebrospinal fluid (CSF).
2. Collect 2 mL of CSF directly into 1 of the collection tubes listed above*


Transport Temperature
Refrigerated


Specimen Stability
Ambient: 12 hours
Refrigerated: 14 days
Frozen: 30 days


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross Hemolysis, Gross icteric
Polystyrene collection tubes are not acceptable


Methodology
Electrochemiluminescent Immunoassay (ECLIA)

FDA Status
LDT: This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

Clinical Significance
Assessment of adults with cognitive impairment being evaluated for Alzheimer disease and other causes of cognitive impairment Biogen’s Amyloid Beta Confirmed Program This test should not be used to predict the development of dementia or other neurologic conditions or to monitor response to therapies.




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.