LucentAD® p-Tau 217

Casandra

Casandra Test Code LU54941Version 1 (DRAFT)

Performing Lab

Lab Lucent DiagnosticsLab Test ID 104620

Clinical Use

Use

The LucentAD® p-Tau 217 test is designed to measure phosphorylated Tau 217 (p-Tau 217) in human plasma. This biomarker is closely linked to amyloid pathology, a hallmark of Alzheimer's disease (AD). The test assists clinicians in determining the likelihood of amyloid plaques in patients presenting with cognitive or memory symptoms. It helps differentiate those with a lower likelihood from those with a higher risk of having AD-related pathology, complementing other diagnostic tools like clinical assessments and imaging.

Special Instructions

This test is integrated with easy onboarding and support for use in clinical settings. Orders can be placed through the provider portal or via paper requisitions. The assay is currently unavailable in New York State, and it is not standalone, meaning it should be used alongside other diagnostic evaluations like clinical and cognitive assessments.

Limitations

The LucentAD® p-Tau 217 test is not FDA cleared and was developed under CLIA standards. It's not a standalone diagnostic tool and should be used as supplementary information to help identify amyloid pathology. Results falling in the intermediate range may need further verification through methods like cerebrospinal fluid biomarker testing or PET imaging to confirm amyloid pathology status.

Test Details

Methodology

Immunoassay (Digital Immunoassay)

Biomarkers

p-Tau 217

Protein

Simoa p-Tau 217 Quantitative Assay • Concentration / Level • Quantitative (Continuous) (e.g., copies/mL, % expression)

Result Turnaround Time

10 days

Specimen

Plasma

Volume

1 mL

Minimum Volume

0.5 mL

Container

Pearl-top tube, gel barrier tube

Collection Instructions

Draw blood in pearl-top (K2 EDTA) tube. Invert to mix with preservatives. Centrifuge and transfer plasma to a labeled plastic transport tube and refrigerate until time to ship.