Immunoassay (IA)
These tests were developed and their performance characteristics determined by the NPDPSC, and have not been cleared or approved by the FDA. These assays should be used in conjunction with other clinical, pathological and laboratory findings.
Specimen requirements | |
|---|---|
| Patient preparation | 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. |
| Preferred specimen(s) | 2 mL frozen CSF collected in a sterile screw-cap vial |
| Alternative specimen(s) | CSF collected Sarstedt CSF false-bottom tube |
| Minimum volume | 1 mL |
| Collection instructions | The patient must be 12 years of age or older. Cerebrospinal Fluid (CSF) obtained by lumbar puncture. The first 2 mL of CSF that flows from the tap should be discarded. Collect 2 mL of CSF (1 mL minimum), avoiding bloody tap. The sample must be immediately frozen, at least in a -20° C freezer. Freeze within 20 minutes of collection. Store and transport frozen. Ship using a styrofoam container with sufficient dry ice (5 lbs/24 hours). 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. *** Ship Monday through Wednesday (priority overnight) *** |
| Transport container | Transport tube |
| Transport temperature | Frozen |
| Specimen stability | Room temperature: Unacceptable Refrigerated: Unacceptable Frozen: Indefinitely |
| Reject criteria | Bloody and insufficient sample quantity • Samples that are colored or contain blood cannot be performed for RT-QuIC and 14-3-3 GAMMA |
| RT-QUIC (CSF) | Negative |
| T-TAU Protein (CSF) | 0-1149 pg/mL |
| 14-3-3 Protein (CSF) | 173-1999 AU/mL |
| Likelihood of prion disease | See Laboratory Report |
Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.
*The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.
This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.
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