| Title: | Development, validation and application of the dried blood spot analysis method for the determination of Ustekinumab in patients with Inflammatory bowel disease |
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| Authors: | ID Mingas, Panagiotis-Dimitrios (Author)
ID Zdovc, Jurij (Author)
ID Grabnar, Iztok (Author)
ID Drobne, David (Author)
ID Vovk, Tomaž (Author) |
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| Files: |  PDF - Presentation file, download (1,44 MB)
MD5: 06AFEB56D249D4E650FAAD9FCE082493
 URL - Source URL, visit https://www.mdpi.com/1424-8247/18/9/1253
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| Language: | English |
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| Typology: | 1.01 - Original Scientific Article |
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| Organization: |  UKC LJ - Ljubljana University Medical Centre
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| Abstract: | Background: Ustekinumab (UST) is a monoclonal antibody (mAb) used in the treatment of inflammatory bowel disease (IBD). Elevated serum concentrations are typically associated with improved therapeutic outcomes, and therapeutic drug monitoring (TDM) is a useful tool for guiding mAbs treatment. This study aimed to develop a dried blood spot (DBS) method for TDM of UST in patients with IBD. Methods: The commercial enzyme-linked immunosorbent assay for plasma samples was optimized for DBS samples and subsequently validated according to international guidelines for classical and DBS-specific validation parameters. It was then applied to analyze serum and DBS samples obtained from venous and capillary blood of IBD patients undergoing UST therapy. Results: The method was linear (3–12 mg/L) with acceptable inter-day accuracy (90.1–106%) and precision (<12%). We confirmed that there was no hematocrit effect and that DBS samples were stable for one month under room conditions. A linear model was developed between venous DBS and serum UST concentrations, which showed no systemic bias, and 71% of the samples were within ±20% of the mean. In addition, a linear correlation between venous DBS and capillary DBS samples was established, showing no significant bias, with 84% of samples within ±20% of the mean. Finally, a novel strategy was developed to overcome the limitations of poor-quality samples (irregular shapes) based on area image analysis. Conclusions: The newly developed DBS method is the first to enable reliable measurement of UST in capillary blood, appropriate clinical interpretation of the measured concentrations, and remote monitoring of patients in the early phase of therapy. |
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| Keywords: | ustekinumab, dried blood spots, venous blood, capillary blood, validation, inflammatory bowel disease, ELISA |
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| Publication status: | Published |
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| Publication version: | Version of Record |
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| Year of publishing: | 2025 |
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| Number of pages: | str. 1-16 |
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| Numbering: | Vol. 18, iss. 9, [article] 1253 |
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| PID: | 20.500.12556/DiRROS-29036  |
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| UDC: | 615.2:616.34-002 |
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| ISSN on article: | 1424-8247 |
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| DOI: | 10.3390/ph18091253 |
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| COBISS.SI-ID: | 246860035 |
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| Note: | Nasl. z nasl. zaslona;
Opis vira z dne 28. 8. 2025;
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| Publication date in DiRROS: | 17.04.2026 |
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| Views: | 37 |
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| Downloads: | 15 |
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