LucentAD^® p-Tau 217

Specimen

K2 EDTA Plasma

Volume

1 mL (Minimum: 0.5mL)

Container

Plasma separator tube (pearl-top)

Collection

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

Storage Instructions

Refrigerated 7 days, Frozen 14 days, Stable for 3 freeze/thaw cycles

Stability Requirements

Stable at refrigerated and frozen conditions

Causes for Rejection

Hemolysis, insufficient volume, improper storage

Specimen

K2 EDTA Whole Blood

Volume

Fill Tube

Container

Plasma separator tube (pearl-top)

Collection

Draw blood in pearl-top (K2 EDTA) tube. Invert to mix with preservatives. Whole blood should be placed immediately into an activated refrigerated shipper. Ship the same day as collection.

Storage Instructions

Must arrive at the lab in a refrigerated shipper within 48 hours of collection. Do not freeze whole blood.

Stability Requirements

Stable at refrigerated and frozen conditions

Causes for Rejection

Hemolysis, insufficient volume, improper storage

Use

Used for the measurement of phosphorylated Tau 217 (p-Tau 217) in human plasma. P-Tau 217 is associated with amyloid pathology, a hallmark of Alzheimer’s disease.

Limitations

• Not FDA cleared (Developed under CLIA)
• Should be used alongside other diagnostic tools
• Results should be interpreted in clinical context

Methodology

Simoa^® Ultra-Sensitive Technology

Reference Interval

Amyloid Risk Score (0-100)
<0.040: Low Likelihood of amyloid pathology
0.041-0.089: Intermediate likelihood
>0.090: High likelihood

Specificity

91.3%

Accuracy

90.7%

Sensitivity

90.3%