CSF Panel for Prion Markers

14-3-3 (ELISA), Total TAU (ELISA) and RT-QuIC Panel
CPT Code 86317 (14-3-3 & TAU), 0035U (RT-QuIC)
Ordering Recommendation May aid in diagnosis of prion disease.
Assumes that the patient has a history of a rapid neurodegenerative condition and does not have several conditionsi that might compromise the test results.
Methodology Quantitative Enzyme-Linked Immunosorbent Assay (ELISA). 
Real-Time Quaking-Induced Conversion (RT-QuIC)ii.
Available STAT No. 
Analytic Timeiii 7 business days.
New York DOH Approval Status This panel is New York DOH approved.
Submit With Order NPDPSC Test Request Form


Specimen Requirements
Patient preparation Patient must be 12 years of age or older.
Specimen Type Cerebrospinal Fluid (CSF) obtained by lumbar puncture.
Preferred Container Cerebrospinal Fluid kit tubes, or sterile containers.
Specimen Preparation The first 2ml of CSF that flows from the tap should be discarded. Collect 2 ml of CSF (1 ml minimum), avoiding bloody tap. Sample must be immediately frozen, at least in a -20°C freezer.
Storage/Transport Temperature

Frozen. Shipping transport on dry ice.iv.

Please note: shipments are not received on weekends and/or holidays. Ship only Monday through Thursday (priority overnight).

Unacceptable Conditions Bloody and insufficient sample quantity.
Remarks Complete the required test request form linked above.
Stability Freeze CSF (at least under -20°C) immediately after collection. 

: Indefinitely.


Specimen Reporting
Critical Results None.
Reference Range(s) for Non-Prion Disease RT-QuIC: Negative
Total TAU (ELISA): 0-1149 pg/ml
14-3-3 GAMMA (ELISA): <30-1999 AU.



i. Conditions include, but are not limited to, subarachnoid hemorrhage, various encephalitis, stroke with acute infarction, mutli-infarct dementia with acute infarction, brain neoplasm and paraenoplastic neurological disorders. These conditions may yield false-positive results.
ii. CSF RT-QuIC has a diagnostic sensitivity and specificity of 90.3% and 98.5%, respectively (Rhoads DD, Neurology 2020).

iii. Expected turnaround-time (business days) for results, beginning when the center receives the specimen.
iv. A recent re-evaluation of the shipment conditions of CSF specimens showed that shipment at room temperature caused an average loss of ~50% for the 14-3-3 protein (range ~32 to ~91%) and ~9% for tau, when compared with shipment of frozen CSF samples on dry ice.