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Test Code FFTYC Collagen Type II antibody

Reporting Name

Collagen Type II Antibodies

Performing Laboratory

IMMCO Diagnostics, Inc.

Specimen Type

Serum


Specimen Required


Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 3 mL

Collection Instructions:

1. Draw blood in plain, red-top tube(s) or serum-gel tube(s).

2. Centrifuge and aliquot serum into a plastic vial.

3. Send refrigerated.


Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 7 days
  Frozen  365 days

Reference Values

Negative: <20 EU/mL

 

Borderline/Equivocal: 20-25 EU/mL

 

Positive: >25 EU/mL

Day(s) Performed

Once Weekly

Test Classification

This test has been developed and performance parameters have been validated by IMMCO Diagnostics, Inc. This test has not been approved by the U.S. Food and Drug Administration (FDA); however, US FDA approval is not required for clinical use. It is not intended that clinical diagnosis and patient management decisions be made using these results alone. This test has been validated using serum samples. The manufacturer has not determined the efficacy of this test when performed on CSF, plasma, joint or pleural fluid specimens. The performance characteristics of this test were determined by IMMCO Diagnostics Inc.

CPT Code Information

83520

LOINC Code Information

Test ID Test Order Name Order LOINC Value
FFTYC Collagen Type II Antibodies 13879-2

 

Result ID Test Result Name Result LOINC Value
Z0911 Collagen Type II Antibodies 13879-2

Report Available

4 to 18 days

Interpretation

Anti-collagen II antibodies occur in 22% of patients with idiopathic SNHL, 30% of patients with sudden deafness and 20% of patients with Meniere’s disease. Anti-collagen II antibodies also occur in patients with relapsing polychondritis and in rheumatoid arthritis.

Method Name

Enzyme Linked Immunosorbent Assay (ELISA)

Secondary ID

91496