Harmonization protocols for thyroid stimulating hormone (TSH) immunoassays: different approaches based on the...

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Assay Development

Background:

• Lack of interchangeable laboratory results and consensus in current practices necessitates standardization and harmonization projects.
• Debate exists on achieving measurement comparability for immunoassays, especially for heterogeneous proteins.
• Standardization requires calibration traceability to the International System of Units (SI unit) via a reference measurement procedure (RMP).

Purpose of the Study:

• To evaluate the effectiveness of external quality assessment (EQA) data in harmonizing thyrotropin (TSH) immunoassay results.
• To compare the harmonization potential of EQA data with complex statistical approaches.
• To address the need for method harmonization in immunoassays, particularly for TSH, where accepted RMPs are unavailable.

Main Methods:

• Utilized data from an external quality assessment (EQA) study.
• Compared results obtained from EQA data with those from a complex statistical approach applied to 14 TSH immunoassay methods.
• Analyzed the variability reduction between different TSH immunoassay methods.

Main Results:

• Data from an EQA study demonstrated the ability to achieve harmonization of TSH immunoassay results.
• The harmonization achieved using EQA data was comparable to results obtained with a complex statistical approach.
• EQA studies provide a viable method for reducing variability in TSH immunoassay measurements.

Conclusions:

• External quality assessment (EQA) studies can yield results similar to sophisticated statistical methods for TSH immunoassay harmonization.
• EQA data offers a practical approach to improve the comparability of laboratory results for TSH immunoassays.
• Harmonization through EQA is a valuable strategy in the absence of established reference measurement procedures.