AD-Detect™ ABeta 42/40 and p-tau217 Evaluation, Plasma
Test Summary
AD-DetectTM ABeta 42/40 and p-tau217 Evaluation, Plasma-Intended use is for Alzheimer's Diagnosis. Independent measurement and interpretation of plasma amyloid ratios (AB42/40) and phosphorylated tau levels (p-tau181 and p-tau217) provide clinically valuable insight into patient risk for development of Alzheimer's disease. However, by combining core AD pathological markers for a single analytical interpretation have been shown to significantly improve predictive performance and accuracy for detecting amyloid positivity and confirming a diagnosis of Alzheimer's disease. The AD-DetectTM ABeta 42/40 and p-tau217 Evaluation Plasma evaluates a patient's AB42/40 ratios and p-tau217 levels reports out the likelihood that a symptomatic patient suspected of AD has a High, Indeterminant, or Low likelihood of amyloid pathology consistent with AD. This panel meets established performance criteria for confirming a diagnosis of Alzheimer's disease utilizing plasma biomarkers.
Aliases
- Phosphorylated tau
- ptau 217
- AB 42
- Dementia
- Alzheimer's Diagnostic panel
- Alzheimer’s Disease
- Alzheimer's diagnosis,Amyloid beta 42
- Phospho tau
Specimen Collection
Special Instructions
N/A
Preferred Specimen
2.5 mL plasma collected in a K2 EDTA (lavender-top) tube split into two equal aliquots
Minimum Volume
0.5 mL
Instructions
Quest Diagnostics does not perform this test for individuals under the age of 18. Pre-test and post-test counseling is strongly recommended.
Collect blood into a K2 EDTA (lavender-top) tube and mix by inversion 10 times. Centrifuge to separate plasma from cells within 1 hour of collection. Carefully transfer plasma into 2 separate polypropylene tubes or 2 separate Quest issued polypropylene pour-off/transfer tubes. Do not transfer to conical tubes. Store frozen.
Patient Preparation
Patients should be cautioned to stop biotin consumption at least 72 hours prior to collection of a sample.
Storage
Frozen
Transport Temperature
Frozen
Specimen Stability
- Room temperature: Unacceptable
- Refrigerated: 72 hours
- Frozen: 28 days
Limitations
N/A
Other Acceptable Specimens
N/A
Unacceptable Specimens
- Moderate hemolysis
- Gross hemolysis
- Specimen collected in a glass, polystyrene, or polycarbonate tube
- K3 EDTA tube
- K2 EDTA gel separator tube
Order Code
ADABEV
EPIC (Premier) Code
Includes
- AD-Detect™ Likelihood Score Interpretation
- Quest AD-Detect™ Beta-Amyloid 42/40 Ratio, Plasma
- Quest AD-Detect™ Phosphorylated tau217(p-tau217), Plasma
- AD-Detect™ Likelihood Score
CPT Code
- 82233
- 82234
- 84393
Billing Code
- 670707
- 670757
- 670784
CPT Statement
Methodology
Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS)
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
14225 Newbrook Drive
Chantilly VA, 20153
Department
Reference Range
- ABeta 42 Not Established
- ABeta 40 Not Established
- ABeta 42/40 Ratio ≥ 0.170
- AD Detect p-tau217≤0.15 pg/mL
- AD Detect Likelihodd Score
- Likelihood of amyloid PET positivity
- Low Likelihood <0.3254
- Indeterminant 0.3254-0.6460
- High Likelihood >0.6460
Setup Schedule / Expected Turnaround Time
Set up: Monday -Saturday; Report available: 3-5 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
2.5 mL plasma collected in a K2 EDTA (lavender-top) tube split into two equal aliquots
Minimum Volume
0.5 mL
Instructions
Quest Diagnostics does not perform this test for individuals under the age of 18. Pre-test and post-test counseling is strongly recommended.
Collect blood into a K2 EDTA (lavender-top) tube and mix by inversion 10 times. Centrifuge to separate plasma from cells within 1 hour of collection. Carefully transfer plasma into 2 separate polypropylene tubes or 2 separate Quest issued polypropylene pour-off/transfer tubes. Do not transfer to conical tubes. Store frozen.
Patient Preparation
Patients should be cautioned to stop biotin consumption at least 72 hours prior to collection of a sample.
Storage
Frozen
Transport Temperature
Frozen
Specimen Stability
- Room temperature: Unacceptable
- Refrigerated: 72 hours
- Frozen: 28 days
Limitations
N/A
Other Acceptable Specimens
N/A
Unacceptable Specimens
- Moderate hemolysis
- Gross hemolysis
- Specimen collected in a glass, polystyrene, or polycarbonate tube
- K3 EDTA tube
- K2 EDTA gel separator tube
Result Information
Methodology
Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS)
Testing Laboratory
Reference Range
- ABeta 42 Not Established
- ABeta 40 Not Established
- ABeta 42/40 Ratio ≥ 0.170
- AD Detect p-tau217≤0.15 pg/mL
- AD Detect Likelihodd Score
- Likelihood of amyloid PET positivity
- Low Likelihood <0.3254
- Indeterminant 0.3254-0.6460
- High Likelihood >0.6460
Setup Schedule / Expected Turnaround Time
Set up: Monday -Saturday; Report available: 3-5 days