Home
HelpTest Code ADEVL Alzheimer Disease Evaluation, Spinal Fluid
Specimen Required
Supplies:
Alzheimer's Disease Evaluation (ADEVL) Collection Kit (T836)
CSF AD Biomarker Tubes (T833; also included in T836)
Container/Tube:
Preferred: Sarstedt CSF False Bottom Tube 63.614.625 (2.5 mL)
Acceptable: Sarstedt 72.703.600 (1.5 mL) or Sarstedt 72.694.600 (2 mL)
Specimen Volume: 1.5 to 2.5 mL
Collection Instructions:
1. Perform lumbar puncture and discard the first 1 to 2 mL of cerebrospinal fluid (CSF).
2. Collect CSF directly into one of the listed collection tubes until the tube is at least 50% full.*
3. Send CSF specimen in original collection tube. Do not aliquot.
Note: Polystyrene collection tubes are not acceptable. Exposure of CSF to polystyrene tubes may result in falsely low Abeta42 concentrations. For more information see Cautions.
*The Alzheimer's Association consensus protocol for handling of CSF for clinical measurements of Abeta42 and tau recommends using the drip method for CSF collection and directly collecting into a low-bind polypropylene tube. Although some clinicians prefer the syringe pull method due to speed of collection, the drip method reduces the risk of Abeta42 binding to the plastic of any syringe used.
4. Collection instructions can also be found on Spinal Fluid Specimen Collection Instructions for Alzheimer Disease Evaluation (T967).
Useful For
Assessment of adults with cognitive impairment being evaluated for Alzheimer disease and other causes of cognitive impairment
These assays should not be used to predict the development of dementia or other neurologic conditions or to monitor response to therapies.
Method Name
Electrochemiluminescent Immunoassay (ECLIA)
Reporting Name
Alzheimer's Disease Evaluation, CSFSpecimen Type
CSFSpecimen Minimum Volume
See Specimen Required
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| CSF | Refrigerated (preferred) | 14 days | BlueTop SARSTEDT |
| Frozen | 60 days | BlueTop SARSTEDT | |
| Ambient | 12 hours | BlueTop SARSTEDT |
Reference Values
Beta-amyloid (1-42) (Abeta42): >834 pg/mL
Total-Tau: ≤238 pg/mL
Phosphorylated-Tau 181: ≤21.6 pg/mL
p-Tau/Abeta42: ≤0.028
Interpretation
A beta-amyloid (1-42; Abeta42) result greater than 834 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 834 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-Tau181) 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-Tau181 concentration of less than or equal to 238 pg/mL and less than or equal to 21.6 pg/mL, respectively, reduces the likelihood that a patient's cognitive impairment is due to AD.
The use of p-Tau181/Abeta42 ratio provides better concordance with amyloid PET scan when compared to Abeta42, p-Tau181, and t-Tau individually. The p-Tau/Abeta42 ratio provides better concordance with amyloid PET imaging when compared to Abeta42, phospho-Tau and total-Tau individually. A cut-off of 0.028 provides optimal balance between negative percent agreement (NPA) and positive percent agreement (PPA) when compared to amyloid PET results. A p-Tau/Abeta42 ratio of 0.028 or less has a 92% NPA with normal amyloid PET. A ratio above 0.028 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 (-) phospho Tau (-) total Tau (-) |
Normal concentrations of Abeta42, phospho-Tau, and total-Tau concentrations are present in CSF. These results are not consistent with the presence of pathological changes associated with Alzheimer disease. |
|
Abeta42 (+) phospho-Tau (-) total-Tau (-) |
Abnormal Abeta42 concentrations are present in CSF. Phospho-Tau and total-Tau concentrations are normal. These results may be consistent with Alzheimer-related pathologic change. |
|
Abeta42 (+) phospho-Tau (+) total-Tau (-) |
Abnormal Abeta42 and phospho-Tau concentrations are present in CSF. The total-Tau concentration is normal. These results are consistent with the presence of Alzheimer disease. |
|
Abeta42 (+) phospho Tau (+) total Tau (+) |
Abnormal Abeta42, phospho-Tau and total-Tau concentrations are present in CSF. These results are consistent with the presence of Alzheimer disease. |
|
Abeta42 (+) phospho Tau (-) total Tau (+) |
Abnormal Abeta42, and total-Tau concentrations are present in CSF. The phospho-Tau concentration is normal. These results may be consistent with Alzheimer-related pathologic change. |
|
Abeta42 (-) phospho-Tau (+) total-Tau (-) |
Abnormal phospho-Tau concentrations are present in CSF. Abeta42 and total-Tau concentrations are normal. These results are not consistent with the presence of pathological changes associated with Alzheimer disease. |
|
Abeta42 (-) phospho tau (-) total-Tau (+) |
Abnormal total-Tau concentrations are present in CSF. The Abeta42 and phospho-Tau concentrations are normal. These results are not consistent with the presence of pathological changes associated with Alzheimer disease. |
|
Abeta42 (-) phospho-Tau (+) total-Tau (+) |
Abnormal phospho-Tau and total-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 disease. |
This table and interpretations are based on the National Institute on Aging and Alzheimer's Association research framework diagnostic recommendations.
Clinical Reference
1. Peyro Saint Paul L, Debruyne D, Bernard D, Mock DM, Defer GL. Pharmacokinetics and pharmacodynamics of MD1003 (high-dose biotin) in the treatment of progressive multiple sclerosis. Expert Opin Drug Metab Toxicol. 2016;12(3):327-344
2. Grimsey P, Frey N, Bendig G, et al. Population pharmacokinetics of exogenous biotin and the relationship between biotin serum levels and in vitro immunoassay interference. J Pharmacokinet Pharmacodyn. 2017;2(4):247-256. doi:10.4155/ipk-2017-0013
3. van Harten AC, Wiste HJ, Weigand SD, et al. Detection of Alzheimer's disease amyloid beta 1-42, p-tau, and t-tau assays. Alzheimers Dement. 2022;18(4):635-644. doi:10.1002/alz.12406
4. Campbell MR, Ashrafzadeh-Kian S, Petersen RC, et al. P-tau/AB42 and AB42/40 ratios in CSF are equally predictive of amyloid PET status. Alzheimers Dement (Amst). 2021;13(1):e12190. doi:10.1002/dad2.12190
5. Blennow K, Stomrud E, Zetterberg H, et al. Second-generation Elecsys cerebrospinal fluid immunoassays aid diagnosis of early Alzheimer's disease. Clin Chem Lab Med. 2022;61(2):234-244. doi:10.1515/cclm-2022-0516
6. Leuzy A, Mattsson-Carlgren N, Cullen NC, et al. Robustness of CSF AB42/40 and AB42/P-tau181 measured using fully automated immunoassays to detect AD-related outcomes. Alzheimers Dement. 2023;19(7):2994-3004. doi:10.1002/alz.12897
7. Jack CR Jr, Bennett DA, Blennow K, et al. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018;14(4):535-562
8. Lifke V, Kollmorgen G, Manuilova E, et al. Elecsys Total-Tau and Phospho-Tau (181P) CSF assays: Analytical performance of the novel, fully automated immunoassays for quantification of tau proteins in human cerebrospinal fluid. Clin Biochem. 2019;72:30-38
9. Hansson O, Seibyl J, Stomrud E et al. CSF biomarkers of Alzheimer's disease concord with amyloid-beta PET and predict clinical progression: A study of fully automated immunoassays in BioFINDER and ADNI cohorts. Alzheimers Dement. 2018;14(11):1470-1481
10. Shaw LM, Arias J, Blennow K, et al. Appropriate use criteria for lumbar puncture and cerebrospinal fluid testing in the diagnosis of Alzheimer's disease. Alzheimers Dement. 2018;14(11):1505-1521
11. Hansson O, Batrla R, Brix B, et al. The Alzheimer's Association international guidelines for handling of cerebrospinal fluid for routine clinical measurements of amyloid beta and tau. Alzheimers Dement. 2021;17(9):1575-1582. doi:10.1002/alz.12316
Day(s) Performed
Tuesday, Thursday, Friday
Report Available
1 to 4 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
83520 x 3
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| ADEVL | Alzheimer's Disease Evaluation, CSF | 104134-2 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| PTABR | p-Tau/Abeta42 | 41027-4 |
| ADINT | AD Interpretation | 69048-7 |
| AB42P | Abeta42 | 33203-1 |
| TTAUP | Total-Tau | 30160-6 |
| PTAUP | Phospho-Tau(181P) | 72260-3 |
Forms
If not ordering electronically, complete, print, and send a Neurology Specialty Testing Client Test Request (T732) with the specimen.