Cortisol assays across the physiologic spectrum: access immunoassay compared with LC-MS/MS

Andrew J Newman1, Sanan Mahrokhian1, Isabelle Hanna1

  • 1Center for Adrenal Disorders, Division of Endocrinology, Diabetes, and Metabolism, Mass General Brigham, Harvard Medical School, Boston, MA 02115, United States.

Insights

This study demonstrates that the Access Cortisol immunoassay closely correlates with the gold-standard liquid chromatography-tandem mass spectrometry (LC-MS/MS) for measuring serum cortisol levels across a wide physiologic range.

Area of Science:

  • Endocrinology
  • Clinical Chemistry
  • Assay Development

Background:

  • Cortisol immunoassays are widely used for adrenal function testing.
  • Previous studies have not comprehensively validated immunoassay performance against LC-MS/MS across the full spectrum of cortisol production.

Purpose of the Study:

  • To compare the performance of the Access Cortisol immunoassay with LC-MS/MS for serum cortisol measurement.
  • To assess immunoassay accuracy across morning, post-dexamethasone suppression, and post-cosyntropin stimulation conditions.

Main Methods:

  • A cross-sectional study involving 97 adults without adrenal disease.
  • Serum cortisol was measured using the Access Cortisol immunoassay and LC-MS/MS at three time points.
  • Analysis included correlation and concordance assessments using common clinical cutoffs.

Main Results:

  • The Access Cortisol immunoassay showed good correlation with LC-MS/MS across the physiologic spectrum.
  • Agreement was closer at lower cortisol levels (post-dexamethasone suppression) than at higher levels (post-cosyntropin stimulation).
  • High concordance (Cohen's κ > 0.89) was observed using standard interpretative cutoffs for all conditions.

Conclusions:

  • The Access Cortisol immunoassay provides reliable cortisol measurements comparable to LC-MS/MS.
  • Clinicians can be confident in using this immunoassay for evaluating adrenal function across varying cortisol levels.
Abstract