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A reference system for cortisol

L M Thienpont¹

¹Laboratorium voor Analytische Chemie, Faculteit van de Farmaceutische Wetenschappen, Universiteit Gent, Belgium. linda.thienpont@rug.ac.be

Clinical Biochemistry

|September 19, 1998

Summary

The International Federation of Clinical Chemistry (IFCC) pilot study demonstrates a method for standardizing hapten immunoassays using metrological traceability. This approach ensures accurate patient sample results by calibrating tests against primary reference materials.

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Area of Science:

Clinical Chemistry
Metrology
Immunoassay Standardization

Background:

The International Federation of Clinical Chemistry (IFCC) is implementing a standardization concept for hapten immunoassays.
This concept focuses on metrological traceability, linking measurement results to SI units via primary reference materials.
Accurate calibration of measurement procedures is crucial for reliable patient sample analysis.

Purpose of the Study:

To pilot the standardization of hapten immunoassays using cortisol as an example.
To evaluate the accuracy of routine immunoassay systems through correlation studies with reference methods.
To establish a basis for the general implementation of metrological traceability in immunoassays.

Main Methods:

A panel of human serum samples was assigned cortisol values using isotope dilution-gas chromatography/mass spectrometry reference methods.
Manufacturers measured these samples with their calibrated immunoprocedures.
Patient correlation studies between routine and reference methods were conducted to assess accuracy and specificity.

Main Results:

Correlation studies were interpreted to evaluate the accuracy and specificity of routine immunoassay systems.
The potential for using these comparisons for recalibration was investigated.
The pilot study provided insights for developing recommendations for manufacturers on correlation studies.

Conclusions:

The pilot study successfully demonstrated a framework for standardizing hapten immunoassays based on metrological traceability.
This approach enhances the accuracy and reliability of patient sample measurements.
The findings are expected to guide the broader implementation of standardized immunoassays.

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