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Test ID EDN Eosinophil Derived Neurotoxin, Serum


Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial within 12 hours of collection. Serum cannot sit on either gel or cells for longer than 12 hours.


Useful For

Evaluating patients suspected to have a condition associated with eosinophilia or hypereosinophilia

 

Evaluating patients with elevated peripheral blood eosinophil counts

 

Managing patients with elevated eosinophil-derived neurotoxin in the context of eosinophil-associated diseases

Method Name

Fluorescence Enzyme Immunoassay (FEIA)

Reporting Name

Eosinophil Derived Neurotoxin, S

Specimen Type

Serum

Specimen Minimum Volume

0.3 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 7 days
  Frozen  21 days

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK
Heat-treated specimen Reject
If serum is on cell pellet or gel for >12 hours Reject

Clinical Information

Eosinophils are a type of white blood cell (WBC) that derives from myeloid progenitor cells.(1) They are a critical part of the immune response to helminth and other infections and play a significant role in allergic diseases. Eosinophils are characterized by their cytoplasmic granules, which appear dark red when stained with eosin. These cytoplasmic granules contain a number of cytotoxic proteins, including major basic protein, eosinophil cationic protein, and eosinophil-derived neurotoxin (EDN). Upon activation, eosinophils degranulate, with subsequent release of these proteins into the extracellular space. These proteins exhibit a variety of activities, with EDN being a ribonuclease having antiviral activity. Eosinophils generally comprise less than 5% of the total WBC count. Eosinophilia and hypereosinophilia are defined by elevated numbers of eosinophils in the peripheral blood at 500/mcL and above and 1500/mcL and above, respectively. Apart from situations of a normal immune response, elevated eosinophil numbers can be found in allergy, asthma, malignancies, immunodeficiencies, autoimmune diseases, and eosinophilic disorders. In some cases, peripheral blood eosinophil counts may not accurately reflect elevated numbers of eosinophils found in tissues; absolute counts also do not indicate the level of eosinophil activation and degranulation. EDN concentrations have been shown to correlate with peripheral blood eosinophil counts and may provide additional information related to activation status.(2,3)

Reference Values

<70 mcg/L: Normal

70-99 mcg/L: Borderline

≥100 mcg/L: Elevated

Reference values apply to all ages.

Interpretation

Eosinophil-derived neurotoxin (EDN) concentrations greater than or equal to 100 mcg/L, in the presence of elevated numbers of peripheral blood or tissue-resident eosinophils, may be suggestive of inflammation or increased disease activity in patients with eosinophil-associated diseases.

 

In the context of normal eosinophil counts, EDN concentrations greater than 70 mcg/L may indicate cellular activation and degranulation.

 

In the context of elevated eosinophil counts, EDN concentrations less than or equal to 70 mcg/L may indicate limited or absent cellular activation.

Cautions

Prolonged contact of serum with the cell pellet can lead to increased concentrations of serum eosinophil-derived neurotoxin (EDN). Serum should be aliquoted into a plastic vial immediately (within 12 hours) after centrifugation.

 

Elevated concentrations of EDN are not diagnostic for any specific condition and should be correlated with other laboratory data and clinical information.

 

Normal EDN concentrations do not exclude the possibility of eosinophilia or hypereosinophilia.

Clinical Reference

1. Wechsler ME, Munitz A, Ackerman SJ, et al: Eosinophils in health and disease: A state-of-the-art review. Mayo Clin Proc. 2021 Oct;96(10):2694-2707

2. Rutten B, Young S, Rhedin M, et al: Eosinophil-derived neurotoxin: A biologically and analytically attractive asthma biomarker. PLoS ONE. 2021 Feb 10;16(2):e0246627

3. Rydell N, Nagao M, Ekoff H, et al: Development of an automated ImmunoCAP research assay for eosinophil derived neurotoxin and its use in asthma diagnosis in children. Pract Lab Med. 2019 Sep 19;17:300138

Method Description

Anti-eosinophil derived neurotoxin (EDN) antibodies, covalently bound to lmmunoCAP, bind to EDN in the patient sample. After washing, enzyme labeled antibodies against EDN are added to form a complex. Following incubation, the unbound enzyme labelled anti-EDN antibodies are washed away, and the bound complex is incubated with a developing agent. After the reaction has been stopped, the fluorescence of the eluate is measured. The response value correlates to the amount of EDN in the sample and a calibration curve is used to transform the response values to concentrations.(Package insert: Phadia ImmunoCAP EDN Assay Kit. Thermo Scientific; Rev 09/2020)

Day(s) Performed

Tuesday

Report Available

2 to 8 days

Test Classification

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

CPT Code Information

83520

NY State Approved

Yes