Korean Journal of Nuclear Medicine Technology (Korean J Nucl Med Technol)

Open access, Peer Reviewed

Indexed in KCI, DOAJ

pISSN 1229-9901
eISSN 2982-8406

Original article

Clinical Application of Measurement Uncertainty-Based Decision Criteria for Qualitative Anti-HBc Radioimmunoassay

1Department of Nuclear Medicine, The Catholic University of Korea, Incheon St. Mary’s Hospital, Incheon, Korea
2Department of Nuclear Medicine, The Catholic University of Korea, Yeouido St. Mary’s Hospital, Seoul, Korea

†These authors contributed equally to this work.

Correspondence to Yeun-Ho Cha. Department of Nuclear Medicine, Incheon St. Mary’s Hospital, 56 Dongsu-ro, Bupyeong-gu, Incheon, 21431, Republic of Korea. Tel: +82-32-280-5249, E-mail: chachacha-123@hanmail.net

Volume 30, Number 2, Article 14, November 2026. Korean J Nucl Med Technol 2026;30(2):14. https://doi.org/10.12972/kjnmt.2026.30.2.14
Received on April 27, 2026, Revised on July 01, 2026, Accepted on July 08, 2026, Published on November 30, 2026.
This is an Open Access article distributed under the terms of the Creative Commons CC BY 4.0 license (https://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Purpose: To estimate the measurement uncertainty (MU) of the qualitative Anti-HBc radioimmunoassay based on the Guide to the Expression of Uncertainty in Measurement (GUM) and to redefine the gray zone near the cut-off using zeta-scores to improve the reliability of clinical decisions. Materials and Methods: The MU of the RIAKEY Anti-HBc RIA Tube assay using a Gamma 10 counter was evaluated using a bottom-up approach. Five uncertainty components were analyzed: repeatability, reproducibility, inter-detector efficiency, pipette accuracy, and inner-detector variability. Combined standard uncertainty was calculated using the root sum square method, and expanded uncertainty was estimated with a coverage factor (k=2.10) based on an approximately 95% confidence level. A zeta-score model and the cumulative distribution function (CDF) of the t-distribution were applied to establish a quantitative gray zone and calculate the probability of false classification. Results: Reproducibility was the largest contributor to MU (57.67%), followed by inter-detector efficiency (37.75%) and inner-detector variability (3.85%). The expanded uncertainty of the cut-off was calculated as 18,066 ± 412 cpm. The MU-based gray zone established using the zeta-score model reduced the indeterminate interval by approximately 67.76% compared to the conventional arbitrary criterion of cut-off ±10%. Application of the zeta-score and t-CDF allowed for the quantitative reporting of clinical results, clearly distinguishing between definitive classifications and indeterminate cases requiring retesting based on a ±2.10 zeta-score threshold. Conclusion: The MU-based gray zone optimized the decision interval and enhanced the precision of the qualitative Anti-HBc assay. The probabilistic approach utilizing zeta-scores and t-CDF provides an objective criterion for interpreting results, which is expected to strengthen the consistency and reliability of clinical decision-making in nuclear medicine in vitro diagnostics.
Keywords

Measurement uncertainty, Qualitative test, Radioimmunoassay, Anti-HBc, Zeta-score

Section