Decentralized clinical trial design using blood microsampling technology for serum bioanalysis
Lee et al.
The finding, in our words
In a 16-donor validation study, prompt centrifugation of serum microsamples maintained analyte stability and preserved clinical chemistry and protein biomarker quality. This demonstrates that remote centrifugation with refrigerated shipping can lessen patient burden and broaden participation in decentralised clinical trials.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
Low volume sampling devices showed good concordance with venous serum for measuring the pharmacodynamic biomarker sMAdCAM-1, but dried blood samples required substantial dilution to overcome buffer interference, which was mitigated by using a highly sensitive Simoa assay. The study demonstrates that while these devices have potential for decentralised clinical trials, careful validation is needed to address site-specific biases and assay sensitivity limitations.
The homeRNA capillary blood collection and stabilization platform successfully captured lipopolysaccharide-induced inflammatory gene expression profiles. These transcriptomic responses were comparable to those obtained from traditional venous blood samples stabilized with RNAlater or PAXgene, demonstrating the platform's suitability for remote transcriptomic monitoring.
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.
Self-collected capillary blood samples posted by standard mail showed high concordance with couriered venous samples for HbA1c, creatinine and lipid parameters, supporting their use for remote monitoring in diabetes management and screening.
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.