Abstract
Paper-based immunoassays are effective methods that employ microfluidic paper-based analytical devices (μPADs) for the rapid, simple, and accurate quantification of analytes in point-of-care diagnosis. In this study, we developed a wax-printed multilayered μPAD for the colorimetric detection of carcinoembryonic antigen (CEA), where the device contained a movable and rotatable detection layer to allow the μPAD to switch the state of the sample solutions, i.e., flowing or storing in the sensing zones. A smartphone with a custom-developed program served as an automated colorimetric reader to capture and analyze images from the μPAD, before calculating and displaying the test results. After optimizing the crucial conditions for the assay, the proposed method exhibited a wide linear dynamic range from 0.5 to 70 ng/mL, with a low CEA detection limit of 0.015 ng/mL. The clinical performance of this method was successfully validated using 50 positive and 40 negative human serum samples, thereby demonstrating the high sensitivity of 98.0% and specificity of 97.5% in the detection of CEA. The proposed method is greatly simplified compared with the cumbersome steps required for traditional immunoassays, but without any loss of accuracy and stability, as well as reducing the time needed to detect CEA. Complex and bulky instruments are replaced with a smartphone. The proposed detection platform could potentially be applied in point-of-care testing.
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Funding
We are grateful for the financial support by the National Key Research and Development Program of China (Grant Nos. 2017FYA0205303 and 2017FYA0205301), the National Natural Science Foundation of China (Grant Nos. 81571835 and 81672247), and the Shanghai Science and Technology Fund (No. 15DZ225200), and the funding of SJTU (Nos. ZH2018QNA03 and YG2019QNB09).
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Wang, K., Yang, J., Xu, H. et al. Smartphone-imaged multilayered paper-based analytical device for colorimetric analysis of carcinoembryonic antigen. Anal Bioanal Chem 412, 2517–2528 (2020). https://doi.org/10.1007/s00216-020-02475-1
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DOI: https://doi.org/10.1007/s00216-020-02475-1