2024 · Journal of mass spectrometry : JMS · paywalled
Enhancing drug development and clinical studies with patient-centric sampling using microsampling techniques: Opportunities, challenges, and insights into liquid chromatography-mass spectrometry strategies
Chen et al.
The finding, in our words
Microsampling enables home-based specimen collection for drug development and clinical trials, reducing patient burden and expanding enrolment diversity, but requires bridging studies to ensure data comparability with conventional methods and faces analytical challenges that LC-MS strategies aim to address.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
An IQ Consortium position paper from sponsor scientists positioning patient-centric sampling as the enabling technology for decentralised trials, and stating that a bridging study against conventional sampling “has quickly been established as a regulatory expectation”.
This study validated a low-cost 3D-printed smartphone attachment and paper sensor for measuring glucose, uric acid and cholesterol in saliva, demonstrating high correlation with standard ELISA results in a small clinical cohort. The authors suggest this platform offers a scalable solution for decentralised diabetes management by balancing sensitivity with affordability.
A machine learning model called Remote Control was trained on 2685 blood samples to predict change due to instability, enabling accurate calibration of results to approximate the time zero value at collection. With calibration, unprocessed whole blood could be transported for up to 9 days under ambient conditions and temperatures between 3.4 and 47.4 degrees Celsius, achieving agreement with CLIA TEa between 98.1 and 100 per cent and expanding the catalog of tests available for at-home collection.
This UK consensus opinion outlines how clinical laboratories can validate self-collected capillary blood sampling against venous reference standards to achieve accreditation and facilitate the shift towards community-based patient care.
This developer study reports that a self-collection kit interfacing with a BD Microtainer produced RNA of sufficient quality and yield for transcriptomic analysis in a pilot group and a longitudinal rheumatology cohort. Most participants found the device easy to use, supporting its utility for decentralised blood sampling.