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Development and validation of a selective SPR aptasensor for the detection of anticancer drug irinotecan in human plasma samples

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Abstract

In this work, a surface plasmon resonance (SPR)-based assay for the quantification of antineoplastic drug irinotecan in human plasma samples has been developed for the first time. The selective binding of irinotecan with an aptamer receptor, operating in human plasma, allowed to set-up a novel analytical methodology to detect the drug in the analytical range of interest by using SPR as detection technique. After hybridizing the aptamer to the sensing platform and optimizing the sample preparation procedure, a quantitative assay was validated according to FDA regulatory guidelines. The analytical working range was found between 100 and 7500 ng mL−1 with negligible interferences from plasma components and co-medication associated with the administration of irinotecan. The utility of the new SPR assay was confirmed by analyzing plasma samples in parallel with LC-MS as reference technique, providing a new analytical tool for the therapeutic drug monitoring of irinotecan in patients under chemotherapy regimens.

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Funding

This work was supported by the Italian Ministry of Health (Ricerca Corrente). We acknowledge Regione Friuli-Venezia-Giulia trough the POR FESR 2014–2020 (project “Nano Diagnostics and Automated Tools for Oncology,” NADIATools) and the grant AIRC 5X1000 (Rif. 12214) “Application of advanced nanotechnology in the development of innovative cancer diagnostics tools” for financial support.

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Authors and Affiliations

  1. Clinical and Experimental Pharmacology, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Via Franco Gallini 2, Aviano (PN), 33081, Italy

    Adelina Puscasu, Martina Zanchetta, Bianca Posocco, Stefano Tartaggia & Giuseppe Toffoli

  2. Department of Chemical and Pharmaceutical Sciences, University of Trieste, Via Giorgieri 1, 34127, Trieste, Italy

    Martina Zanchetta

  3. Aptamer Group, Suite 2.78 – 2.91, Bio Centre, Innovation Way, Heslington, York, YO10 5NY, UK

    David Bunka

Authors
  1. Adelina Puscasu
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  2. Martina Zanchetta
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  3. Bianca Posocco
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  4. David Bunka
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  5. Stefano Tartaggia
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  6. Giuseppe Toffoli
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Corresponding author

Correspondence to Stefano Tartaggia.

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Conflict of interest

D. Bunka is a Co-founder and Director of Aptamer Group and therefore has financial interest in Aptamer Group Ltd. A. Puscasu, M. Zanchetta, B. Posocco, S. Tartaggia, and G. Toffoli have no conflicts to declare regarding the publication of this manuscript.

Ethics approval

Plasma samples were collected from patients enrolled in a phase Ib clinical study (CRO-2009-25, Prot. n. 0041793(09)-PRE.21-984) approved by the ethics committee of CRO-National Cancer Institute of Aviano (Italy) and by Istituto Superiore di Sanità (ISS, Italy), which was conducted according to the principles expressed in the Declaration of Helsinki. Informed consent was obtained from all participants involved in the study.

Source of biological material

Control human plasma stabilized with K2EDTA for the preparation of daily standard calibration curves and quality control (QC) samples was obtained from healthy volunteers and was provided by the Transfusion Unit of the Centro di Riferimento Oncologico di Aviano (CRO), Italy.

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Puscasu, A., Zanchetta, M., Posocco, B. et al. Development and validation of a selective SPR aptasensor for the detection of anticancer drug irinotecan in human plasma samples. Anal Bioanal Chem 413, 1225–1236 (2021). https://doi.org/10.1007/s00216-020-03087-5

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  • DOI: https://doi.org/10.1007/s00216-020-03087-5

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