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Test Code Billings Clinic: 4792 Mayo: 21OH 21-Hydroxylase Antibodies, Serum

Reporting Name

21-Hydroxylase Ab, S

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Investigating adrenal insufficiency

 

Aiding in the detection of those at risk of developing autoimmune adrenal failure in the future

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)


Ordering Guidance


Testing for autoantibodies against 21-hydroxylase is recommended following confirmation of adrenal insufficiency to help differentiate between causes of primary adrenal insufficiency



Shipping Instructions


Ship specimen frozen on dry ice



Specimen Required


Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial to remove from cells or gel prior to shipping.


Specimen Type

Serum

Specimen Minimum Volume

0.2 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Frozen 14 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Reference Values

Negative

Interpretation

This is a qualitative test. A positive result indicates the presence of autoantibodies to 21-hydroxylase and is consistent with Addison disease.

 

Utilizing an index value of <45 as a negative cutoff, this assay has a clinical sensitivity and specificity of 87.0% (95% CI: 79.4%-92.2%) and 99.3% (95% CI: 97.5%-99.8%), respectively.

Day(s) Performed

Wednesday

Report Available

3 to 9 days

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

83516

LOINC Code Information

Test ID Test Order Name Order LOINC Value
21OH 21-Hydroxylase Ab, S 85363-0

 

Result ID Test Result Name Result LOINC Value
607788 21-Hydroxylase Ab, S 85363-0