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AD-Detect ® Phosphorylated TAU217 (P-TAU217)

Test Summary

Quest AD-Detect® Phosphorylated tau217(p-tau217), Plasma - 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.

Aliases

  • pT217,Phosphorylated Tau 217 (217P),Ptau217,Phosphorylated tau217

Specimen Collection

Special Instructions

N/A

Preferred Specimen

0.7 mL plasma collected in an EDTA (lavender-top) tube. Refrigerated

Minimum Volume

0.5 mL

Instructions

N/A

Patient Preparation

Patients should be cautioned to stop biotin consumption at least 72 hours prior to collection of a sample

Storage

Refrigerated

Transport Temperature

Refrigerated

Specimen Stability

  • Room Temperature: 5 days Refrigerated: 14 days Frozen: 28 days

Limitations

N/A

Other Acceptable Specimens

N/A

Unacceptable Specimens

N/A

Order Code

ADP217

EPIC (Premier) Code

LAB6917

Includes

N/A

CPT Code

  • 84393

Billing Code

  •  670175

CPT Statement

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.

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675

Reference Range

≤0.15 pg/mL

Setup Schedule / Expected Turnaround Time

Monday - Saturday; Report available: 1 - 3 days

Specimen Collection

Special Instructions

N/A

Preferred Specimen

0.7 mL plasma collected in an EDTA (lavender-top) tube. Refrigerated

Minimum Volume

0.5 mL

Instructions

N/A

Patient Preparation

Patients should be cautioned to stop biotin consumption at least 72 hours prior to collection of a sample

Storage

Refrigerated

Transport Temperature

Refrigerated

Specimen Stability

  • Room Temperature: 5 days Refrigerated: 14 days Frozen: 28 days

Limitations

N/A

Other Acceptable Specimens

N/A

Unacceptable Specimens

N/A

Billing

CPT Code

  • 84393

Billing Code

  •  670175

CPT Statement

Result Information

Methodology

Immunoassay (IA)

Testing Laboratory

N/A

Reference Range

≤0.15 pg/mL

Setup Schedule / Expected Turnaround Time

Monday - Saturday; Report available: 1 - 3 days