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Current status and performance goals for serum thyrotropin (TSH) assays
C A Spencer1, M Takeuchi, M Kazarosyan
1Department of Medicine, University of Southern California, Los Angeles 90033, USA. cspencer@hsc.usc.edu
Clinical Chemistry
|January 1, 1996
Summary
Reliable measurement of low thyrotropin (TSH) concentrations is crucial for cost-effective thyroid management. This review highlights the need for standardized functional sensitivity assessments in TSH assays to ensure accurate clinical laboratory results.
Area of Science:
- Clinical Chemistry
- Endocrinology
- Laboratory Medicine
Background:
- Accurate thyrotropin (TSH) measurement is essential for thyroid disorder diagnosis and management.
- Current medical needs require TSH assays capable of reliably measuring low concentrations for cost-effective TSH-centered strategies.
- The American Thyroid Association recommends TSH-centered strategies, necessitating sensitive TSH assays.
Purpose of the Study:
- To review the functional performance of current TSH immunometric assay methods used in clinical practice.
- To identify and discuss methodological differences, sensitivity limits, and specificity issues in TSH assays.
- To recommend a standardized protocol for functional sensitivity assessment and improve assay reliability.
Main Methods:
- Review of existing TSH immunometric assay methods and their performance characteristics.
- Analysis of factors affecting functional sensitivity, including interassay coefficient of variation (CV).
- Examination of TSH-related and non-TSH-related specificity challenges.
Main Results:
- Methodological variations exist among TSH assays, impacting reliability.
- The 20% interassay CV is often used as a functional sensitivity limit, but a clinically relevant standard protocol is needed.
- Both TSH-related and non-TSH-related factors can compromise assay specificity.
Conclusions:
- A clinically relevant standard protocol for functional sensitivity assessment is recommended for manufacturers and laboratories.
- Laboratories should independently verify and monitor their TSH assay functional sensitivity.
- Collaboration between manufacturers and laboratories is vital to address sensitivity and specificity issues for consistent, reliable TSH measurements.