Ad-Detect™ p-Tau217/Beta-Amyloid 1--42 Ratio, P
PTABP
Test Summary
AD-Detect™ p-tau217/Beta-Amyloid 1-42 Ratio, Plasma (FDA Cleared) is cleared by the FDA for assessment of patients aged >=50 years with signs or symptoms of cognitive decline. The levels of two proteins, p-tau217 and Beta-amyloid 1-42, are evaluated within the plasma and calculated into an analytical ratio. This ratio is correlated to the presence or absence of amyloid plaques in the patient's brain, which may reduce the need for an amyloid-PET scan.
Aliases
Dementia, MCI, p-Tau217/42 ratio, Alzheimer's Disease, Amyloid beta 42
Specimen Collection
Special Instructions
N/A
Preferred Specimen
1 mL plasma collected in a K2EDTA (lavender-top) tube.
Minimum Volume
0.75 mL
Instructions
Centrifuge sample within 2 hours of collection and transfer to a polypropylene tube for transport. Freeze within 24 hours. Transport frozen.
Patient Preparation
N/A
Storage
Plastic screw-cap vial
Transport Temperature
Frozen
Specimen Stability
Room temperature: Unacceptable
Refrigerated: 24 hours
Frozen: 30 days
Limitations
The Lumipulse G pTau 217/Beta-Amyloid 1-42 Plasma Ratio result must be interpreted in conjunction with other patient clinical information.
Other Acceptable Specimens
N/A
Unacceptable Specimens
Hemolysis
Order Code
PTABP
EPIC (Premier) Code
LAB
Includes
ptau217,ABeta 42,ptau217/ABeta 42 Ratio
CPT Code
84393
82234
Billing Code
671394
671395
CPT Statement
Methodology
Fujirebio Lumipulse Chemiluminescent Enzyme Immunoassay
FDA Status
FDA Approved
Physician Attestation of Informed Consent
N/A
Testing Laboratory
33608 Ortega Highway
San Juan Capistrano CA, 92675
Department
Reference Range
ptau217 Not Established
ABeta 42 Not Established
ptau217/ABeta 42 Ratio <=0.00370
Plasma p-tau217/ABeta 42 Ratio Risk Table
Lower Risk <=0.00370
Indeterminate Risk 0.00371-0.00737
Higher Risk >=0.00738
Setup Schedule / Expected Turnaround Time
Monday-Saturday; Report available: 4 - 6 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
1 mL plasma collected in a K2EDTA (lavender-top) tube.
Minimum Volume
0.75 mL
Instructions
Centrifuge sample within 2 hours of collection and transfer to a polypropylene tube for transport. Freeze within 24 hours. Transport frozen.
Patient Preparation
N/A
Storage
Plastic screw-cap vial
Transport Temperature
Frozen
Specimen Stability
Room temperature: Unacceptable
Refrigerated: 24 hours
Frozen: 30 days
Limitations
The Lumipulse G pTau 217/Beta-Amyloid 1-42 Plasma Ratio result must be interpreted in conjunction with other patient clinical information.
Other Acceptable Specimens
N/A
Unacceptable Specimens
Hemolysis
Result Information
Methodology
Fujirebio Lumipulse Chemiluminescent Enzyme Immunoassay
Testing Laboratory
Reference Range
ptau217 Not Established
ABeta 42 Not Established
ptau217/ABeta 42 Ratio <=0.00370
Plasma p-tau217/ABeta 42 Ratio Risk Table
Lower Risk <=0.00370
Indeterminate Risk 0.00371-0.00737
Higher Risk >=0.00738
Setup Schedule / Expected Turnaround Time
Monday-Saturday; Report available: 4 - 6 days