여덟 가지 시약으로 측정한 혈청 갑상선자극호르몬 결과값 차이: 무증상갑상선기능저하증 진료지침의 임상 적용을 위한 참고구간 비교 연구
Comparison of Thyroid-Stimulating Hormone Results from Eight Different Reagents and Assay-Specific Korean Reference Interval for Subclinical Hypothyroidism Treatment
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Background and Objectives: Recent guidelines from the Korean Thyroid Association have proposed a threshold of 6.8 mIU/L for diagnosing subclinical hypothyroidism based on local research findings. However, due to the lack of standardization/harmonization, thyroid-stimulating hormone (TSH) testing yields varying results across different reagent manufacturers. Hence, the use of uniform reference intervals is challenging. We aimed to establish assay-specific Korean reference interval for TSH. Materials and Methods: We performed duplicate measurements on 100 serum samples with varying TSH concentrations (0-23 mIU/L) using eight different TSH reagents including Alinity I TSH (Abbott), Access TSH (Beckman Coulter), Elecsys TSH (Roche), TSH3UL (Siemens), TSH IRMA (Beckman Coulter), TSH1 RIA (Brahms), TSH IRMA TUBE II (Riakey), Turbo TSH IRMA (Izotop). Correlation and simple linear regression analyses were conducted among 8 reagents with Roche as the reference. Results: The correlation coefficient for each reagent was notably high at 0.99. Through regression analysis, TSH values equivalent to the 6.8 mIU/L (Roche) were determined for each reagent as follows: Abbott 5.2 mIU/L, Beckman 6.5 mIU/L, Siemens 6.9 mIU/L, Beckman-Radioimmunoassay 7.4 mIU/L, Brahms 5.7 mIU/L, Riakey 5.3 mIU/L, Izotop 6.0 mIU/L. Conclusion: Given the observed differences in TSH values associated with different reagents, it is imperative to consider these differences when interpreting results within various clinical contexts and adapting them to clinical practice.
Abstract
Background and Objectives: Recent guidelines from the Korean Thyroid Association have proposed a threshold of 6.8 mIU/L for diagnosing subclinical hypothyroidism based on local research findings. However, due to the lack of standardization/harmonization, thyroid-stimulating hormone (TSH) testing yields varying results across different reagent manufacturers. Hence, the use of uniform reference intervals is challenging. We aimed to establish assay-specific Korean reference interval for TSH. Materials and Methods: We performed duplicate measurements on 100 serum samples with varying TSH concentrations (0-23 mIU/L) using eight different TSH reagents including Alinity I TSH (Abbott), Access TSH (Beckman Coulter), Elecsys TSH (Roche), TSH3UL (Siemens), TSH IRMA (Beckman Coulter), TSH1 RIA (Brahms), TSH IRMA TUBE II (Riakey), Turbo TSH IRMA (Izotop). Correlation and simple linear regression analyses were conducted among 8 reagents with Roche as the reference. Results: The correlation coefficient for each reagent was notably high at 0.99. Through regression analysis, TSH values equivalent to the 6.8 mIU/L (Roche) were determined for each reagent as follows: Abbott 5.2 mIU/L, Beckman 6.5 mIU/L, Siemens 6.9 mIU/L, Beckman-Radioimmunoassay 7.4 mIU/L, Brahms 5.7 mIU/L, Riakey 5.3 mIU/L, Izotop 6.0 mIU/L. Conclusion: Given the observed differences in TSH values associated with different reagents, it is imperative to consider these differences when interpreting results within various clinical contexts and adapting them to clinical practice.
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