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Quest AD-Detect® Phosphorylated tau217(p-tau217), Plasma
Test Code13825
CPT Codes
83520<br><strong>This test is not available for New York patient testing.</strong>
Preferred Specimen
0.7 mL plasma collected in an EDTA (lavender-top) tube
Patient Preparation
Patients should be cautioned to stop biotin consumption at least 72 hours prior to collection of a sample
Minimum Volume
0.5 mL
Instructions
Follow standard protocol for specimen collection and centrifugation then transfer plasma to a labeled plastic transport tube.
Transport Container
Transport tube
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 5 days
Refrigerated: 14 days
Frozen: 28 days
Refrigerated: 14 days
Frozen: 28 days
Methodology
Immunoassay (IA)
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.
Setup Schedule
Set up: Mon-Sat; Report available: 2-4 days
Reference Range
≤0.15 pg/mL
Clinical Significance
Current research indicates that plasma p-tau, including p-tau 217, is concordant with amyloid status defined by either CSF biomarker testing or PET scan analysis, and is able to differentiate between AD and non-AD neurodegenerative diseases and to predict progression to AD. Blood-based biomarkers, such as plasma p-tau, could potentially be used as inclusion criteria or to evaluate target engagement and treatment efficacy, and could further advance the development of disease-modifying treatments in the field of AD and related disorders. This assay is designed specifically for the quantitative measurement of tau phosphorylated at threonine 217 (p-tau 217) in human plasma.
Performing Laboratory
Quest Diagnostics Nichols Inst San Juan Capistrano
33608 Ortega Highway
San Juan Capistrano, CA 92690-6130
