|Ordering Recommendation||May aid in diagnosis of Creutzfeldt-Jakob Disease.
Assumes that the patient has a history of acute dementia, but did not have several conditionsi that might compromise the test results.
|Methodology||Quantitative Enzyme-Linked Immunosorbent Assay (ELISA).
Qualitative Real-Time Quaking-Induced Conversion (RT-QuIC)ii.
|Analytic Timeiii||7 business days.|
|New York DOH Approval Status||This panel is New York DOH approved.|
|Submit With Order||NPDPSC Test Request Form|
|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 2-5 ml of CSF (2ml minimum), avoiding bloody tap. Sample must be immediately frozen, at least in a -20°C freezer.|
|Storage/Transport Temperature||Frozen. Shipping transport on dry iceiv.|
|Unacceptable Conditions||Bloody and insufficient sample quantity.|
|Remarks||Complete the required test request form linked above.|
|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.