14-3-3 Protein, CSF (Prion Disease)

Test Code

CPT Codes
83520<br /> **This test is not available for California, Florida, Maryland, Rhode Island patient testing**

If 14-3-3 protein is positive or tau is ≥ 500 pg/mL, then non-orderable RT-QuiC will be performed at an additional charge (CPT code: 0035U).

Preferred Specimen
5 mL CSF collected in sterile screw-cap container

Minimum Volume
1 mL

Collect CSF by lumbar puncture. Discard first 2 mL that flows from tap. Collect next 5 mL CSF, avoiding bloody tap.

Specimen Processing: Freeze within 20 minutes of collection. Store and transport frozen. Ship using a styrofoam container with sufficient dry ice (5 lbs/24 hours). The NPDPSC requests a urine sample for research purposes with all CSF samples if available. Ship Monday through Wednesday.

Required patient information: Please complete and send the National Prion Requisition "Test Request Form", available on the website at National Prion Disease Pathology Surveillance Center with the sample.

In addition to our Test Request Form, all senders of CSF will be required to also complete and submit our CSF Billing Requisition Form only if the NPDPSC is to bill patient directly.

**Please note: Patient is also asked to submit a frozen urine sample (100-200 mL) for validation of a recently published diagnostic test on Creutzfeldt-Jakob disease; no report will be issued. Please inform patient and/or family that urine is used for research on a diagnostic test and obtain oral consent.

Urine: ship double boxed using a styrofoam container with sufficient dry ice (5 lbs/24 hours).

Transport Temperature

Specimen Stability
Room temperature: 24 hours
Refrigerated: 14 days
Frozen: Indefinitely

Immunoassay (IA)

FDA Status
These tests were developed and their performance characteristics determined by the NPDPSC and they have not been cleared or approved by the FDA. These assays should be used in conjunction with other clinical, pathological and laboratory findings.

Setup Schedule
Set up: Tues, Thurs; Report available: 7-10 days

Reference Range
See Laboratory Report

Clinical Significance
Use in CSF: Search for the presence of the 14-3-3 protein. The 14-3-3 protein is a marker for some prion diseases, such as Creutzfeldt-Jakob disease (CJD), when a number of other neurodegenerative conditions are excluded.

Performing Laboratory
National Prion Disease Pathology Surveillance Center
Case Western Reserve University
2085 Adelbert Road, Room 419
Cleveland, OH 44106

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.