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Fluorescent immunochromatographic test strip for therapeutic drug monitoring of methotrexate with high sensitivity and wide dynamic range

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Abstract

As a front-line chemotherapeutic drug for maintenance and consolidation therapy, methotrexate (MTX) has widely been applied to treat various tumors and some inflammatory diseases. However, because of its severe toxicity ascribed to low selectivity, it is necessary to monitor therapeutic drugs in high-dose MTX therapeutic regimens to ensure treatment safety. In this work, we developed a fluorescent immunochromatographic test strip (FITS) for monitoring MTX by employing time-resolved fluorescent microspheres as signal probes. With a competitive immunoassay mode, the FITS for MTX shows a super-wide dynamic range of 10 pM–10 μM, covering the entire clinical therapeutic concentration range of MTX. Therapeutic drug monitoring of MTX can be achieved within 7 min with high specificity, facilitating the timely rescue of drug poisoning led by high-dose MTX treatment. The method was employed for monitoring MTX in the spiked human serum, urine, and milk, showing acceptable recoveries ranging from 94.0 to 110.0%. The established FITS has been applied to MTX detection in serum obtained from high-dose MTX treatment. The results from FITS and enzyme multiplied immunoassay technique showed no significant difference, suggesting its reliability for usage in real biological samples. The device shows promise in point-of-care therapeutic drug monitoring for resource-limited countries and institutes, which significantly facilitates overcoming the lag time between sampling and results.

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Funding

This research was funded by the National Natural Science Foundation of China (21964023).

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Authors and Affiliations

  1. Department of Pharmacy, The Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou Province, China

    Zhongjie Zhu, Ling Huang & Yong He

  2. College of Pharmaceutical Sciences, Southwest University, Chongqing, 400715, China

    Yu Zhang, Jinxia Xue, Hui Ouyang & Zhifeng Fu

  3. Department of Pharmacy, Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou Province, China

    Jing Kong

Authors
  1. Zhongjie Zhu
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  2. Yu Zhang
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  3. Jinxia Xue
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  4. Jing Kong
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  5. Ling Huang
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  6. Hui Ouyang
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  7. Zhifeng Fu
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  8. Yong He
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Correspondence to Zhifeng Fu or Yong He.

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Zhu, Z., Zhang, Y., Xue, J. et al. Fluorescent immunochromatographic test strip for therapeutic drug monitoring of methotrexate with high sensitivity and wide dynamic range. Microchim Acta 190, 342 (2023). https://doi.org/10.1007/s00604-023-05917-6

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  • DOI: https://doi.org/10.1007/s00604-023-05917-6

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