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Patient-Centric Qua...
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Löfgren, LarsTranslational Science and Experimental Medicine, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden
(author)
Patient-Centric Quantitative Microsampling for Accurate Determination of Urine Albumin to Creatinine Ratio (UACR) in a Clinical Setting
- Article/chapterEnglish2024
Publisher, publication year, extent ...
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Oxford University Press (OUP),2024
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LIBRIS-ID:oai:DiVA.org:kth-344336
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https://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-344336URI
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https://doi.org/10.1093/jalm/jfad111DOI
Supplementary language notes
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Language:English
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Summary in:English
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
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QC 20240314
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Background: Developing and implementing new patient-centric strategies for drug trials lowers the barrier to participation for some patients by reducing the need to travel to research sites. In early chronic kidney disease (CKD) trials, albuminuria is the key measure for determining treatment effect prior to pivotal kidney outcome trials. Methods: To facilitate albuminuria sample collection outside of a clinical research site, we developed 2 quantitative microsampling methods to determine the urinary albumin to creatinine ratio (UACR). Readout was performed by LC-MS/MS. Results: For the Mitra device the within-batch precision (CV%) was 2.8% to 4.6% and the between-batch precision was 5.3% to 6.1%. Corresponding data for the Capitainer device were 4.0% to 8.6% and 6.7% to 9.0%, respectively. The storage stability at room temperature for 3 weeks was 98% to 103% for both devices. The recovery for the Mitra and Capitainer devices was 104% (SD 7.0%) and 95 (SD 7.4%), respectively. The inter-assay comparison of UACR assessment generated results that were indistinguishable regardless of microsampling technique. The accuracy based on LC-MS/MS vs analysis of neat urine using a clinical chemistry analyzer was assessed in a clinical setting, resulting in 102 ± 8.0% for the Mitra device and 95 ± 10.0% for the Capitainer device. Conclusions: Both UACR microsampling measurements exhibit excellent accuracy and precision compared to a clinical chemistry analyzer using neat urine. We applied our patient-centric sampling strategy to subjects with heart failure in a clinical setting. Precise UACR measurements using quantitative microsampling at home would be beneficial in clinical drug development for kidney therapies.
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von Euler Chelpin, MarianneTranslational Science and Experimental Medicine, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden
(author)
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Bhat, MariaTranslational Science and Experimental Medicine, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden
(author)
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Althage, MagnusTranslational Science and Experimental Medicine, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden
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Hober, Andreas,1992-KTH,Systembiologi,Science for Life Laboratory, SciLifeLab,Translational Science and Experimental Medicine, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden(Swepub:kth)u15bkxsl
(author)
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Edfors, FredrikKTH,Systembiologi,Science for Life Laboratory, SciLifeLab(Swepub:kth)u149ml0e
(author)
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Ruckh, TimR&D Digital Health, AstraZeneca, Gothenburg, Sweden.
(author)
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Challis, BenjaminTranslational Science and Experimental Medicine, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden
(author)
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Davidsson, PiaTranslational Science and Experimental Medicine, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden
(author)
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Miliotis, TassoTranslational Science and Experimental Medicine, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden
(author)
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Translational Science and Experimental Medicine, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, SwedenSystembiologi
(creator_code:org_t)
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In:The Journal of Applied Laboratory Medicine: Oxford University Press (OUP)9:2, s. 329-3412576-94562475-7241
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Löfgren, Lars
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Bhat, Maria
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Ruckh, Tim
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Royal Institute of Technology