Kosin Medical Journal

Original articles

Comparative evaluation of two automated immunoassays for serum thyroglobulin quantification: Kyoung Ho Roh, Hyunyong Hwang; Kosin Med J. 2025;40(3):213-220. Published online September 23, 2025; DOI: https://doi.org/10.7180/kmj.25.122

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Abstract PDF PubReader ePub: Background
We evaluated the clinical performance of in vitro diagnostic devices for quantifying thyroglobulin (Tg), which is a key marker for monitoring and treating thyroid dysfunction. The recently launched Siemens Atellica IM Tg assay was compared with the established Roche Elecsys Tg II assay using residual serum samples from routine testing.
Methods
The precision, linearity, limit of blank (LoB), limit of detection (LoD), limit of quantitation (LoQ), and reference ranges were assessed using the Siemens Atellica IM Tg assay. In total, 681 patient serum samples were analyzed to compare the results with those of the Roche Elecsys Tg II assay for correlation and concordance evaluations across the clinical ranges.
Results
The precision coefficients of variation, linearity, LoB, LoD, and LoQ for the Siemens Atellica IM Tg assay met the manufacturer’s specifications across all concentrations. All data points and confidence intervals were within the allowable deviation from linearity. The correlation between the assays was excellent (Pearson’s r=0.997). In the low range, concordance was 83%, whereas in the normal range, it reached 98%. In contrast, the highly abnormal range exhibited a concordance of 65%, resulting in an overall concordance rate of 88%. Weighted kappa values (κ=0.79–0.82) demonstrated moderate-to-strong agreement.
Conclusions
The Siemens Atellica IM Tg assay showed performance consistent with the precision, linearity, LoB, LoD, LoQ, and reference ranges claimed by the manufacturer. It demonstrated a strong correlation and good overall concordance with Roche Elecsys Tg II. Lower concordance in the highly abnormal range suggests a potential limitation.

Comparative analysis of Access PCT and Elecsys BRAHMS PCT assays for procalcitonin measurements: Hyunji Choi, Sang-Shin Lee, Hyunyong Hwang; Kosin Med J. 2024;39(4):272-280. Published online December 20, 2024; DOI: https://doi.org/10.7180/kmj.24.155

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Background
Procalcitonin (PCT) is a crucial biomarker for diagnosing sepsis and managing antibiotic therapy. This study evaluated the analytical performance and comparability of the Access PCT and Elecsys BRAHMS PCT assays.
Methods
The precision, detection capability, linearity, and reference range of both assays were assessed. A comparative analysis included 182 patient samples categorized into four risk groups to compare the results between Access PCT and Elecsys BRAHMS PCT assays.
Results
The Access PCT assay demonstrated precision within the manufacturer’s threshold, and its detection capabilities were verified. This assay exhibited excellent linearity and appropriate reference intervals. Comparative analysis indicated that the Access PCT assay reported higher overall PCT levels than the Elecsys BRAHMS assay, with high agreement between the assays (κ=0.941). However, the biases varied across different PCT concentration intervals.
Conclusions
Both the Access PCT and Elecsys BRAHMS PCT assays performed robustly with notable concordance but varying biases at different concentration intervals. The observed biases require careful consideration in clinical decision-making, especially when adopting novel assay systems. Standardizing the calibration across different platforms is recommended to improve assay comparability.

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Comparative evaluation of two automated immunoassays for serum thyroglobulin quantification
Kyoung Ho Roh, Hyunyong Hwang
Kosin Medical Journal.2025; 40(3): 213. CrossRef

Improvement of Precision in TL Response with an Automated TLD Reader: Soo kil Kim; Kosin Med J. 1999;14(1-2):113-122.

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