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Test Code P1433 14-3-3 Protein, Spinal Fluid

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Supporting, in conjunction with other tests, a diagnosis of Creutzfeldt-Jakob disease in patients with rapidly progressive dementia when other neurodegenerative conditions have been excluded.

Method Name

Immunochemiluminometric Assay (ICMA)

Reporting Name

14-3-3 Protein, CSF

Specimen Type

CSF


Specimen Required


Collection Container/Tube: Sterile vial

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

1. Obtain aliquot from second collection vial.

2. Hemolyzed specimens will give false-positive results. Specimens should be centrifuged to remove any red cells before shipping. The test will be canceled if there is any level of hemolysis present.

3. Immediately place aliquot on ice.

Additional Information:

1. Specimens that have not been kept refrigerated, or which have been tested for other analytes previously, may give a false-positive result.

2. Separate specimens should be submitted when multiple tests are ordered. This will reduce the risk of test cancellation due to stability problems.


Specimen Minimum Volume

1 mL CSF on ice; Pediatric or minimum volume: 0.6 mL CSF on ice

Specimen Stability Information

Specimen Type Temperature Time
CSF Refrigerated (preferred) 7 days
  Frozen  90 days

Reject Due To

Hemolysis

Mild reject; Gross reject

Lipemia

NA

Icterus

NA

Other

NA

Reference Values

Normal: ≤2.0 ng/mL

Elevated: >2.0 ng/mL

Interpretation

A concentration of 14-3-3 protein in cerebrospinal fluid (CSF) of 2.0 ng/mL or higher supports the diagnosis of Creutzfeldt-Jakob disease (CJD) in patients who have been carefully preselected based on various diagnostic criteria. CSF 14-3-3 measurement is particularly helpful in sporadic CJD, where it is used as one of several diagnostic criteria.

 

Sporadic CJD World Health Organization (WHO) diagnostic criteria from 1998:

1. Definitive CJD:

-Neuropathological diagnosis by standard techniques AND/OR immunohistochemistry AND/OR Western blot confirmed protease-resistant prion protein AND/OR presence of scrapie-associated fibrils

 

2. Probable CJD:

-Progressive dementia

-At least 2 of the following symptoms:

-Myoclonus, pyramidal/extrapyramidal, visual or cerebellar, akinetic mutism

-Positive electroencephalographs (EEG) (periodic epileptiform discharges) AND/OR positive CSF 14-3-3 protein and less than 2 years disease duration

-No alternate diagnosis

 

3. Possible CJD:

-Progressive dementia

-At least 2 of the following symptoms:

-Myoclonus, pyramidal/extrapyramidal, visual or cerebellar, akinetic mutism

-No supportive EEG and less than 2 years disease duration

 

Recently proposed, but not yet universally accepted, amendments to these criteria center on including magnetic resonance imaging (MRI) high-signal abnormalities in caudate nucleus and/or putamen on diffusion-weighted imaging (DWI) or fluid attenuated inversion recovery (FLAIR) as diagnostic criteria for probable CJD.

 

The USA Center of Disease Control and Prevention supports these modified WHO criteria as of 2010 (http://www.cdc.gov/ncidod/dvrd/cjd/diagnostic_criteria.html).

 

There is no established role for 14-3-3 measurement in the diagnosis of acquired or inherited CJD.

Day(s) and Time(s) Performed

Monday, Thursday: 2 p.m.

Analytic Time

2 days

Specimen Retention Time

3 months

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information

83520

LOINC Code Information

Test ID Test Order Name Order LOINC Value
P1433 14-3-3 Protein, CSF 36924-9

 

Result ID Test Result Name Result LOINC Value
82528 14-3-3 Protein, CSF 36924-9