지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
커뮤니티
연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 발행연도
- 2024.4
- 수록면
- 100 - 105 (6page)
- DOI
- 10.47429/lmo.2024.14.2.100
이용수
초록· 키워드
오류제보하기
Background: Glycated albumin (GA) is a biomarker of short-term glycemic status. Several cases of extremely low GA levels measured by Norudia GA assay kits (Sekisui Medical Co., Ltd., Tokyo, Japan) were inconsistent with clinical status. This study evaluated the analytical performance of the modified version of the Norudia GA that claims to have resolved the false negative issue.
Methods: Precision and linearity were evaluated following the guidance of the Clinical & Laboratory Standards Institute (CLSI) EP05-A3 and EP06-A, respectively. A comparison study was performed against the Lucica GA-L (Asahi Kasei Pharma Corporation, Tokyo, Japan) based on CLSI EP09-A3. The temperature stability of GA was also assessed. The reference interval was verified following CLSI EP28-A3C.
Results: Coefficients of variation in the precision analysis were all acceptable. Linearity assessment demonstrated a coefficient of determination (R2) of 0.998. The comparison study showed a high correlation coefficient (r) of 0.973 relative to the Lucica GA-L. Stability analysis revealed GA tended to increase with storage duration. The transference of the reference interval was verified. Negative interference was reduced in the modified version of the Norudia GA.
Conclusions: The modified version of the Norudia GA assay showed comparable performance in measuring GA as well as reduced interference in samples that had shown false negative results with the original version of the Norudia GA. The modified assay may avoid negative interference putatively caused by anti-oxidative agents in clinical laboratories using the original version of the Norudia GA assay.
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