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A Rapid Test Strip for Diagnosing Glycosylated Hemoglobin (HbA1c) Based on Fluorescent Affinity Immunochromatography

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Abstract

In this research, we developed a rapid and easy-to-operate point-of-care testing (POCT) strip based on fluorescent affinity immunochromatography to quantitatively determine HbA1c concentrations in whole blood. This assay, based on a sandwich method performed on test strips, effectively utilized the principle of an affinity chromatography column, which was commonly used in the detection of HbA1c, and the technology of traditional fluorescence immunochromatographic test strips (FICTS) were combined. In our test strips, the test line of traditional FICTS was transformed into the region of affinity chromatography, while improving the linearity and reducing the interference of the precursor of HbA1c and hemoglobin variants. The test strips could quantitatively detect HbA1c over a wide range (3–13.8%) with excellent linearity (R2 > 0.99), and the assay accuracy was demonstrated by comparing with high-performance liquid chromatography (HPLC) (R2 > 0.95). The simple, rapid, effective and quantitative strips will provide a novel method for the detection of HbA1c in clinical diagnosis.

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Acknowledgments

This work was supported by the National Key Research and Development Program of China (No. 2017YFA0205502); National Natural Science Foundation of China (No. 81571806, 81671820); the Science and Technology Support Project of Jiangsu Province (No. BE2017763); the Jiangsu Provincial Special Program of Medical Science (No. BL2013029); and the Fundamental Research Funds for the Central Universities.

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Authors and Affiliations

  1. State Key Laboratory of Bioelectronics, Jiangsu Key Laboratory for Biomaterials and Devices, School of Biological Science and Medical Engineering & Collaborative Innovation Center of Suzhou Nano Science and Technology, Southeast University, Nanjing, P. R. China

    Chaoman Ang, Doudou Lou, Wei Chen, Ning Gu & Yu Zhang

  2. Nanjing Nanoeast Biotech Co., Ltd., Nanjing, P. R. China

    Linling Hu

  3. Laboratory Medicine Center, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, P. R. China

    Yefei Zhu & Zhirui Guo

Authors
  1. Chaoman Ang
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  2. Doudou Lou
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  3. Linling Hu
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  4. Wei Chen
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  5. Yefei Zhu
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  6. Zhirui Guo
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  7. Ning Gu
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  8. Yu Zhang
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Corresponding authors

Correspondence to Ning Gu or Yu Zhang.

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Ang, C., Lou, D., Hu, L. et al. A Rapid Test Strip for Diagnosing Glycosylated Hemoglobin (HbA1c) Based on Fluorescent Affinity Immunochromatography. ANAL. SCI. 34, 1117–1123 (2018). https://doi.org/10.2116/analsci.18P135

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  • DOI: https://doi.org/10.2116/analsci.18P135

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