Biogen Program, Alzheimer Disease Evaluation, CSF to Mayo


Abbrev Code:MMMISC   
Order Code:LAB4909Order Name:Send Outs Misc Test
Synonyms:Amyloid Beta; Biogen's Amyloid Beta Confirmed Program
Methodology:Electrochemiluminescent immunoassay
Turnaround Time:Specimens are sent to the reference laboratory Mon-Fri; results are reported within 1-8 days.
Special Instructions:This test is only available as part of Biogen's Amyloid Beta Confirmed Program.

The following information is required:
  • Current disease state (mild, moderate or severe)
  • Zip code of patient
  • Sponsor registration code.
 
Compliance:

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.

Associated Links:

Mayo Biogen Program Request Form



Collection Instructions

Specimen:CSF
Optimal Volume:2 mL
Container:See Collection Instructions
Collection Instructions:Supplies: Alzheimer's Disease Evaluation (ADEVL) Collection Kit (T836) available from Mayo Laboratories.
  1. Perform lumbar puncture and discard the first 1 to 2 mL of cerebrospinal flud (CSF)
  2. Collect 2 mL CSF directly into CSF AD Biomarker Tube (preferred) or Sarstedt 72.703.600 (1.5 mL) or Sarstedt 72.694.600 (2 mL). Do not collect sample in polystyrene collection 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.
Causes for Rejection:Grossly hemolyzed or icteric specimens. Polystyrene collection tubes are not acceptable. Exposure of CSF to polystyrene tubes may result in falsely low Abeta42 concentrations.


Processing and Shipping

Specimen Processing:Do not process. Store frozen.
Shipping Instructions:Ship frozen.
Stability:12 hours at room temperature; 14 days refrigerated; 30 days frozen.
Test Performed at or Referral Lab Lab Sendouts  (Mayo Medical Laboratories)
Referral Lab number:ADBIO


Interpretive

Reference Range:
Beta-amyloid (1-42) (Abeta42) >1026 pg/mL
Total-Tau ≤ 238 pg/mL
Phosphorylated-Tau (p-Tau) 181 ≤ 21.7 pg/mL
p-Tau/Abeta42 ≤ 0.023
 
Use:Assessment of adults with cognitive impairment being evaluated for Alzheimer disease and other causes of cognitive impairment. This test should not be used to predict the development of dementia or other neurologic conditions or to monitor response to therapies.


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