Instability of harmonized thyroid‐stimulating hormone immunoassays in clinical practice
Authors' conclusion
We have confirmed that TSH harmonization in clinical practice is relatively stable. However, some patients showed deviating TSH levels in the harmonized TSH immunoassays, indicating the need for caution, particularly in poorly nourished patients. This finding suggests the presence of factors that contribute to the instability of TSH harmonization in such cases. Further investigation is warranted to validate these results.
Study context
- Population
- Patients in clinical practice tested with four harmonized thyroid-stimulating hormone (TSH) immunoassays
- Participants
- 431 patients
- Comparison
- Four harmonized TSH immunoassays compared with each other
- Outcome
- Reactivity of harmonized TSH immunoassays
Methodological detailsfour harmonized TSH immunoassays, combined difference plots
- Four harmonized TSH immunoassays
- Combined difference plots
Main finding
As reported in the abstract
Patients with statistically significant TSH deviations (3 immunoassays, excluding the deviating one), among 109 with mild-to-moderate TSH elevation
15
Patients whose thyroid hormone levels were misclassified as hypothyroidism or normal due to deviating TSH
3
Further findings
Clinical characteristics of patients with deviating TSH
- Poor nutritional status and general condition, possibly due to severe illness (e.g., advanced metastatic cancer)
Original publication
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