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26323 Biogen Program, Alzheimer Disease Evaluation, Spinal Fluid (ADBIO)

Biogen Program, Alzheimer Disease Evaluation, Spinal Fluid (ADBIO)
Test Code: MISC
Synonyms/Keywords

​Abeta, Amyloid Beta 42, Beta-Amyloid 42, Phosphorylated Tau, pTau, Total Tau, tTau, ADBIO, BIOGEN, AdMark, ADEVL

Useful For

This entry is specific to the BIOGEN research program.

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.

Specimen Requirements
Specimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen Volume
​CSF​CSF AD Biomarker Tube

​Sarstedt 72.703.600 (1.5 mL)   or  

Sarstedt 72.694.600 (2 mL)

​2 mL
Collection Processing Instructions

​*This entry is specific to the BIOGEN research program.  If this is being ordered outside of that research program, order ADEVL to Mayo**

*For those IN the BIOGEN research program, please use test code ADBIO.*

Collect into the T836 collection kit from Mayo.  When more kits are needed, contact Lab-Customer Service at 1-6700.  Supplies are located on the Specimen Processing Mayo Supply shelf.

Specimen Stability Information
Specimen TypeTemperature

Time

​CSF ​ ​

​Refrigerated (preferred)

​14 days

Frozen​​30 days
​Ambient​12 hours
Rejection Criteria

Gross hemolysis

Gross Icterus

Performing Laboratory Information
Performing LocationDay(s) Test PerformedAnalytical TimeMethodology/Instrumentation
​Mayo Clinic Laboratories​Tuesday, Thursday​1 to 8 days​Electrochemiluminescent Immunoassay (ECLIA)
Reference Lab
Reference Range Information

Reference Range

Beta-amyloid (1-42) (Abeta42): >1026 pg/mL

Total-Tau: < or =238 pg/mL

Phosphorylated-Tau (p-Tau) 181: < or =21.7 pg/mL

p-Tau/Abeta42: < or =0.023

Interpretation

A beta-amyloid (1-42; Abeta42) result greater than 1026 pg/mL is consistent with a negative amyloid positron emission tomography (PET) scan. A negative amyloid PET scan indicates the presence of no or sparse neuritic plaques and is inconsistent with a neuropathological diagnosis of Alzheimer disease (AD). An Abeta42 result greater than 1026 pg/mL is associated with a reduced likelihood that a patient's cognitive impairment is due to AD. Total Tau (t-Tau) and phosphorylated Tau (p-Tau) cerebrospinal fluid (CSF) concentrations increase approximately 2 to 3-times as much in patients with mild-moderate AD as compared to age-matched controls. A t-Tau and/or p-Tau concentration of less than or equal to 238 pg/mL and less than or equal to 21.7 pg/mL, respectively, reduces the likelihood that a patient's cognitive impairment is due to AD.

 

The use of p-Tau/Abeta42 ratio provides better concordance with amyloid PET scan when compared to Abeta42, p-Tau and t-Tau individually. A cut-off of 0.023 provides optimal balance between NPA (negative % agreement) and PPA (positive % agreement) when compared to amyloid PET results. A p-Tau/Abeta42 ratio of less than or equal to 0.023 has a 92% NPA with normal amyloid PET. A ratio of greater than 0.023 has a 92% PPA with abnormal amyloid PET.

 

High CSF t-Tau protein concentrations are found in other neurodegenerative diseases such as prion disease or Creutzfeldt-Jakob disease (CJD). In this situation, an elevated t-Tau concentration and an increased t-Tau to p-Tau ratio has a very high specificity for differential diagnoses of CJD.

Abnormal (+)/Normal (-)Individual comments for AD reporting values

Abeta42 (-)

Phosphorylated-Tau (-)

Total-Tau (-)

Normal concentrations of Abeta42, phosphorylated-Tau (p-Tau), and total-Tau (t-Tau) concentrations are present in CSF. These results are not consistent with the presence of pathological changes associated with Alzheimer's disease.

Abeta42 (+)

p-Tau (-)

t-Tau (-)

Abnormal Abeta42 concentrations are present in CSF.

P-Tau and t-Tau concentrations are normal.

These results may be consistent with Alzheimer's related pathologic change. 

Abeta42 (+)

p-Tau (+)

t-Tau (-)

Abnormal Abeta42 and p-Tau concentrations are present in CSF.

The t-Tau concentration is normal.

These results are consistent with the presence of Alzheimer's disease.

Abeta42 (+)

p-Tau (+)

t-Tau (+)

Abnormal Abeta42, p-Tau and t-Tau concentrations are present in CSF. These results are consistent with the presence of Alzheimer's disease.

Abeta42 (+)

p-Tau (-)

t-Tau (+)

Abnormal Abeta42 and t-Tau concentrations are present in CSF.

The p-Tau concentration is normal.

These results may be consistent with Alzheimer's related pathologic change.

Abeta42 (-)

p-Tau (+)

t-Tau (-)

Abnormal p-Tau concentrations are present in CSF.

Abeta42 and t-Tau concentrations are normal.

These results are not consistent with the presence of pathological changes associated with Alzheimer's disease. 

Abeta42 (-)

p-Tau (-)

t-Tau (+)

Abnormal t-Tau concentrations are present in CSF.

The Abeta42 and p-Tau concentrations are normal.

These results are not consistent with the presence of pathological changes associated with Alzheimer's disease.

Abeta42 (-)

p-Tau (+)

t-Tau (+)

Abnormal p-Tau and t-Tau concentrations are present in CSF.

The Abeta42 concentration is normal.

These results are not consistent with the presence of pathological changes associated with Alzheimer's disease. 

 

This table and interpretations are based on the NIA-AA Research Framework diagnostic recommendations.(1)

 

 

Outreach CPTs
CPTModifier
(if needed)
QuantityDescriptionComments
Synonyms/Keywords

​Abeta, Amyloid Beta 42, Beta-Amyloid 42, Phosphorylated Tau, pTau, Total Tau, tTau, ADBIO, BIOGEN, AdMark, ADEVL

Ordering Applications
Ordering ApplicationDescription
​COM​Biogen Program, Alzheimer Eval
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Specimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen Volume
​CSF​CSF AD Biomarker Tube

​Sarstedt 72.703.600 (1.5 mL)   or  

Sarstedt 72.694.600 (2 mL)

​2 mL
Collection Processing

​*This entry is specific to the BIOGEN research program.  If this is being ordered outside of that research program, order ADEVL to Mayo**

*For those IN the BIOGEN research program, please use test code ADBIO.*

Collect into the T836 collection kit from Mayo.  When more kits are needed, contact Lab-Customer Service at 1-6700.  Supplies are located on the Specimen Processing Mayo Supply shelf.

Specimen Stability Information
Specimen TypeTemperature

Time

​CSF ​ ​

​Refrigerated (preferred)

​14 days

Frozen​​30 days
​Ambient​12 hours
Rejection Criteria

Gross hemolysis

Gross Icterus

Useful For

This entry is specific to the BIOGEN research program.

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.

Reference Range Information

Reference Range

Beta-amyloid (1-42) (Abeta42): >1026 pg/mL

Total-Tau: < or =238 pg/mL

Phosphorylated-Tau (p-Tau) 181: < or =21.7 pg/mL

p-Tau/Abeta42: < or =0.023

Interpretation

A beta-amyloid (1-42; Abeta42) result greater than 1026 pg/mL is consistent with a negative amyloid positron emission tomography (PET) scan. A negative amyloid PET scan indicates the presence of no or sparse neuritic plaques and is inconsistent with a neuropathological diagnosis of Alzheimer disease (AD). An Abeta42 result greater than 1026 pg/mL is associated with a reduced likelihood that a patient's cognitive impairment is due to AD. Total Tau (t-Tau) and phosphorylated Tau (p-Tau) cerebrospinal fluid (CSF) concentrations increase approximately 2 to 3-times as much in patients with mild-moderate AD as compared to age-matched controls. A t-Tau and/or p-Tau concentration of less than or equal to 238 pg/mL and less than or equal to 21.7 pg/mL, respectively, reduces the likelihood that a patient's cognitive impairment is due to AD.

 

The use of p-Tau/Abeta42 ratio provides better concordance with amyloid PET scan when compared to Abeta42, p-Tau and t-Tau individually. A cut-off of 0.023 provides optimal balance between NPA (negative % agreement) and PPA (positive % agreement) when compared to amyloid PET results. A p-Tau/Abeta42 ratio of less than or equal to 0.023 has a 92% NPA with normal amyloid PET. A ratio of greater than 0.023 has a 92% PPA with abnormal amyloid PET.

 

High CSF t-Tau protein concentrations are found in other neurodegenerative diseases such as prion disease or Creutzfeldt-Jakob disease (CJD). In this situation, an elevated t-Tau concentration and an increased t-Tau to p-Tau ratio has a very high specificity for differential diagnoses of CJD.

Abnormal (+)/Normal (-)Individual comments for AD reporting values

Abeta42 (-)

Phosphorylated-Tau (-)

Total-Tau (-)

Normal concentrations of Abeta42, phosphorylated-Tau (p-Tau), and total-Tau (t-Tau) concentrations are present in CSF. These results are not consistent with the presence of pathological changes associated with Alzheimer's disease.

Abeta42 (+)

p-Tau (-)

t-Tau (-)

Abnormal Abeta42 concentrations are present in CSF.

P-Tau and t-Tau concentrations are normal.

These results may be consistent with Alzheimer's related pathologic change. 

Abeta42 (+)

p-Tau (+)

t-Tau (-)

Abnormal Abeta42 and p-Tau concentrations are present in CSF.

The t-Tau concentration is normal.

These results are consistent with the presence of Alzheimer's disease.

Abeta42 (+)

p-Tau (+)

t-Tau (+)

Abnormal Abeta42, p-Tau and t-Tau concentrations are present in CSF. These results are consistent with the presence of Alzheimer's disease.

Abeta42 (+)

p-Tau (-)

t-Tau (+)

Abnormal Abeta42 and t-Tau concentrations are present in CSF.

The p-Tau concentration is normal.

These results may be consistent with Alzheimer's related pathologic change.

Abeta42 (-)

p-Tau (+)

t-Tau (-)

Abnormal p-Tau concentrations are present in CSF.

Abeta42 and t-Tau concentrations are normal.

These results are not consistent with the presence of pathological changes associated with Alzheimer's disease. 

Abeta42 (-)

p-Tau (-)

t-Tau (+)

Abnormal t-Tau concentrations are present in CSF.

The Abeta42 and p-Tau concentrations are normal.

These results are not consistent with the presence of pathological changes associated with Alzheimer's disease.

Abeta42 (-)

p-Tau (+)

t-Tau (+)

Abnormal p-Tau and t-Tau concentrations are present in CSF.

The Abeta42 concentration is normal.

These results are not consistent with the presence of pathological changes associated with Alzheimer's disease. 

 

This table and interpretations are based on the NIA-AA Research Framework diagnostic recommendations.(1)

 

 

For more information visit:
Performing Laboratory Information
Performing LocationDay(s) Test PerformedAnalytical TimeMethodology/Instrumentation
​Mayo Clinic Laboratories​Tuesday, Thursday​1 to 8 days​Electrochemiluminescent Immunoassay (ECLIA)
Reference Lab
For billing questions, see Contacts
Outreach CPTs
CPTModifier
(if needed)
QuantityDescriptionComments
For most current information refer to the Marshfield Laboratory online reference manual.