음성 간섭을 감소시키도록 개선된 Norudia 당화알부민 시약의 성능평가
Performance Evaluation of a Modified Version of the Norudia Glycated Albumin Assay that Reduces Negative Interference
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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.
Abstract
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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