B형 간염 사람 면역글로불린 역가시험의 측정불확도 평가 사례 연구

• Published in: Yaghag-hoi-ji Vol. 68; no. 4; pp. 294 - 301
• Main Authors: 최찬웅(Chan Woong Choi), 문형실(Hyung Sil Moon), 방윤수(Yun Su Bang), 손성숙(Seong Suk Son), 김영훈(Young Hoon Kim)
• Format: Journal Article
• Language: Korean
• Published: The Pharmaceutical Society Of Korea 31.08.2024; 대한약학회
• Subjects: 약학; Hepatitis B immunoglobulin; Potency assay; Measurement uncertainty; National lot release
• ISSN: 0377-9556; 2383-9457
• DOI: 10.17480/psk.2024.68.4.294

The potency assay for antibody to hepatitis B surface antigen (HBsAg) has been conducted as a key quality control test for immunoglobulin preparations. In the present study, we aimed to identify uncertainty factors that affect the potency assay and present the first case of calculating measurement uncertainty in national lot release testing for biologicals. Antibody to HBsAg assay was performed using electrochemiluminescence immunoassay (ECLIA) with autoimmunoassay analyzer. Uncertainty factors from actual test conditions were derived by depicting an Ishikawa diagram, and experiments for calculating measurement uncertainties of each factor were conducted. The main uncertainty factors and their measurement uncertainties are presented, which include dilution process for reference materials and samples, calibration curve measurement using reference materials, and sample measurement. In the evaluation of the contribution by each uncertainty factor, calibration curve measurement using reference materials and sample measurement accounted for 55.15% and 27.44%, respectively. The expanded uncertainty was expressed as (252±6) IU/mL (approximately 95% confidence level, k=2). The results of biological assays are known to be influenced by the proficiency of experimenters, and the antibody to HBsAg assay was also found to be more influenced by type A uncertainty factor, such as repeatability, than type B. Recently, the evaluation of measurement uncertainty is recommended for proficiency testing study of biologicals. More efforts to ensure the reliability of national lot release test results are required. KCI Citation Count: 0