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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.
Centrifuge and aliquot serum into plastic vial to remove from cells or gel prior to shipping.
Ship serum specimen frozen
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.
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.
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.