| 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. Frozen: 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. |
References
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.