Test Catalog

Test Id : 21OH

21-Hydroxylase Antibodies, Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

Investigation of adrenal insufficiency

 

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

Highlights

Addison disease is the most frequent cause of primary adrenal insufficiency.

 

Auto-antibodies against 21-hydroxylase are present in up to 90% of Addison disease cases.

 

Measurement of anti-21-hydroxylase auto-antibodies is useful in the evaluation of the cause of established primary adrenal insufficiency.

Method Name
A short description of the method used to perform the test

Enzyme-linked Immunosorbent Assay (ELISA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

21-Hydroxylase Ab, S

Aliases
Lists additional common names for a test, as an aid in searching

21 Hydroxylase Antibody

21-OH Ab

Adrenal Antibody

Anti-Adrenal Antibody

Hydroxylase Antibody

Addison's Disease

Specimen Type
Describes the specimen type validated for testing

Serum

Ordering Guidance

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

Shipping Instructions

Ship serum specimen frozen

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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 plastic vial to remove from cells or gel prior to shipping.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.20 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Frozen (preferred) 14 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Investigation of adrenal insufficiency

 

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Adrenal insufficiency is caused by failure of the adrenal cortex to produce cortisol. This failure can result from loss of function of the adrenal glands (ie, primary adrenal insufficiency). This is most frequently caused by autoimmune adrenalitis or Addison disease accounting for 68% to 94% of cases. It can occur sporadically or in combination with other autoimmune endocrine diseases that together comprise Type I or Type II autoimmune polyglandular syndrome (APS).

 

Antibodies that react with several steroidogenic enzymes (most often 21-hydroxylase) are present in the serum of up to 86% of patients with autoimmune primary adrenal insufficiency, but only rarely in patients with other causes of adrenal insufficiency. Therefore, anti-21-hydroxylase autoantibodies (21-OH Abs) are markers of autoimmune Addison disease, whether it’s present alone, or as part of Type I or Type II APS. The measurement of 21-OH Abs is an important step in the investigation of adrenal insufficiency, and may also aid in the detection of those at risk of developing autoimmune adrenal failure in the future.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative

Interpretation
Provides information to assist in interpretation of the test results

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.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Lipemic or grossly hemolyzed serum should not be used in this assay.

 

Results should be interpreted in the context of clinical symptoms and adrenal functional confirmatory tests.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Charmandari E, Nicolaides NC, Chrousos GP: Adrenal insufficiency. Lancet 2014;383(9935):2152-2167

2. Bancos I, Hahner S, Tomlinson J, Arlt W: Diagnosis and management of adrenal insufficiency. Lancet Diabetes Endocrinol 2015;3(3):216-226

3. Bornstein SR, Allolio B, Arlt W, et al: Diagnosis and Treatment of Primary Adrenal Insufficiency: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab 2016;101(2):364-389

Method Description
Describes how the test is performed and provides a method-specific reference

A reference preparation, controls, and patient specimens are incubated with a reaction enhancer overnight in a coated ELISA plate. 21-Hydroxylase (21-OH) antibodies (Ab) act divalently and form a bridge between 21-OH Ab coated on ELISA plate wells and liquid phase 21-OH biotin. The resulting antigen-antibody-antigen complexes are then detected by the addition of streptavidin peroxidase (SA-POD) and tetramethylbenzidine (TMB) to produce a colorogenic reaction. Stop solution is added to halt the reaction and absorbance is read using an ELISA plate reader. The absorbance of each well is directly proportional to the amount of antibody present. Positive and negative determinations are based on index values. Index values are calculated from the mean value of duplicate sample wells and compared to a reference value.(Package insert: 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit, Kronus, Star, ID. 01/2019)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Wednesday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

2 to 9 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

83516

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports