Performance of enzymatic method for the measurement of HbA1c level using (RE) Norudia N HbA1c
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- NAKAJIMA Atsuko
- Clinical Laboratory Department, Dokkyo Medical University Saitama Medical Center
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- FUJISHIRO Masahiro
- Clinical Laboratory Department, Dokkyo Medical University Saitama Medical Center
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- KAMATA Yasushi
- Clinical Laboratory Department, Dokkyo Medical University Saitama Medical Center
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- MIKI Ryuji
- Clinical Laboratory Department, Dokkyo Medical University Saitama Medical Center
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- UNE Yoko
- Clinical Development Group, Sekisui Medical Co.
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- TOU Masako
- Clinical Laboratory Department, Dokkyo Medical University Saitama Medical Center
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- HARUKI Kousuke
- Clinical Laboratory Department, Dokkyo Medical University Saitama Medical Center
Bibliographic Information
- Other Title
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- 酵素法ヘモグロビンA1c測定試薬「(RE)ノルディアN HbA<sub>1C</sub>」の基礎的検討
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Abstract
<p>Recently, there have been reports of falsely high levels of hemoglobin A1c (HbA1c) when measured using the enzymatic HbA1c assay reagent Norudia N HbA1C in patients with low catalase activity. We performed an analytical investigation of an improved reagent, (RE) Norudia N HbA1c, which has been developed to lower the rate of obtaining falsely high levels, using an EV800 Clinical Analyzer. For within-run reproducibility, the coefficient of variation was from 0.42% to 0.68%. NGSP exhibited a linear dilution from 3.16% to 17.64%. The accuracy was from 98.4% to 101.4%. On-board stability was favorable up to 28 days. HbA1c levels were not affected by free bilirubin (up to 50 mg/dL), conjugated bilirubin (up to 50 mg/dL), formazin turbidity (up to 3,000 FTU), or ascorbic acid (up to 50 mg/dL). Correlation of (RE) Norudia N HbA1c with Norudia N was high, with a correlation coefficient of 0.998 (n = 56). The regression equation was y = 1.000x + 0.010, and no extremely large deviations among samples were found. From the results presented above, the analytical performance of (RE) Norudia N was found to be favorable. The two samples that yielded falsely high HbA1c levels measured using Norudia N did not reveal any significant difference in HbA1c level between (RE) Norudia N and other enzymatic assay reagents, suggesting that (RE) Norudia N suppressed falsely high HbA1c levels. The analytical performance of (RE) Norudia N is favorable, and it lowers the rate of obtaining falsely high HbA1c levels, making it useful for routine testing.</p>
Journal
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- Japanese Journal of Medical Technology
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Japanese Journal of Medical Technology 69 (4), 646-651, 2020-10-25
Japanese Association of Medical Technologists
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Details 詳細情報について
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- CRID
- 1390567901497448320
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- NII Article ID
- 130007931233
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- ISSN
- 21885346
- 09158669
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- Text Lang
- ja
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- Data Source
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- JaLC
- CiNii Articles
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- Abstract License Flag
- Disallowed