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Multicenter performance evaluation of a second generation cortisol assay.

Michael Vogeser1, Jürgen Kratzsch2, Yoon Ju Bae2

  • 1Institute of Laboratory Medicine, Hospital of the University of Munich (LMU), Marchioninistr. 15, 81377 Munich.

Clinical Chemistry and Laboratory Medicine
|November 30, 2016
PubMed
Summary

The new Elecsys® Cortisol II assay accurately measures cortisol levels in serum and saliva, showing excellent agreement with the gold standard LC-MS/MS method. This automated test is suitable for diagnosing adrenocortical diseases.

Keywords:
assaycortisolimmunoassaymethod comparisonperformance evaluation

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Area of Science:

  • Clinical Chemistry
  • Endocrinology
  • Assay Development

Background:

  • Accurate cortisol measurement is critical for diagnosing life-threatening adrenocortical disorders like Cushing's and Addison's disease.
  • The Elecsys® Cortisol II assay is a new, fully-automated second-generation assay for quantifying cortisol.

Purpose of the Study:

  • To evaluate the analytical performance of the Elecsys® Cortisol II assay for serum and saliva cortisol measurement.
  • To assess the assay's precision, reproducibility, and agreement with LC-MS/MS.

Main Methods:

  • Intermediate precision and reproducibility were assessed at four European sites under routine conditions.
  • Method comparison was performed against liquid chromatography-tandem mass spectrometry (LC-MS/MS).
  • Cortisol reference ranges were established using samples from 300 healthy individuals across three US sites.

Main Results:

  • The Elecsys® Cortisol II assay demonstrated high precision with coefficients of variation (CVs) ≤5.8% for serum and ≤10.9% for saliva.
  • Excellent agreement with LC-MS/MS was observed for serum samples (slope=1.02, intercept=4.473 nmol/L).
  • Established reference ranges for serum and saliva cortisol were provided.

Conclusions:

  • The Elecsys® Cortisol II assay exhibits good precision and excellent agreement with LC-MS/MS.
  • The assay is suitable for routine diagnostic use in clinical laboratories.
  • It is a valuable tool for the diagnosis of adrenocortical diseases.