Overview


Test code:

GFAP

Abbreviations, alternative names:

Plasma GFAP

Methodology:

Chemiluminescence assay (CLEIA)

Validation:

Laboratory Developed Test (LDT)

Requirements


Specimen type:

EDTA plasma

Minimum volume:

0.5 mL

Preferred volume:

5 mL

Rejection criteria:

Grossly hemolytic, lipemic, or icteric. If the sample arrives at room temperature

Our offices are only able to receive samples Mon-Sat, so samples must be shipped Mon-Fri. Samples arriving Sunday may need to be re-drawn.

Specimen


GFAP is extremely sensitive to temperature and free/thaw cycles. It is critical that time at room temperature be minimized. Refrigerate when not handling, and immediately after sample has been centrifuged and aliquoted.

Specimen collection:

Overnight fasting is recommended
Draw blood in K2 EDTA tubes (lavender top)
Invert 8 times to ensure complete mixing

Specimen handling:

Centrifuge EDTA tubes at 3,000 - 3,500 rpm for 10-15 minutes (use refrigerated centrifuge, if available)
Draw off plasma into Aliquot tubes with pipette, ensuring not to take gel or RBC (middle/bottom layers)
Store Aliquot tubes in refrigerator (2°C - 8°C) until shipping

Specimen storage:

Plasma samples must either be refrigerated and shipped chilled within 24 hours of collection, or frozen and shipped on dry ice

Specimen stability:

Serum samples may be stored:
Up to 1 week room temperature (20⁰C)
Up to 1 week refrigerated (2 - 8⁰C)
Up to 3 weeks frozen (-20⁰C)
Up to 3 weeks at ultra-low (-80⁰C – -70⁰C)
Up to 4 freeze / thaws

Performance


Testing frequency:

Once per week

Turnaround time:

1 week

Reference range:

< 78.2 ng/L (age 45-65)

Clinical performance:

A-beta PET-Positive vs HC: AUC of 0.96 at Youden index of 93.25 ng/L

Validation:

Laboratory Developed Test (LDT)

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