Scientific Director Altasciences Clinical Research Laval, Quebec, Canada
Numerous microsampling devices currently exist on the market, each leveraging a unique design approach for providing high-quality dried capillary blood samples when collected volumetrically and independent of hematocrit. Examples include the Mitra® VAMS and Capitainer®B for finger-stick sampling, and the Tasso M20 integrated unit with lancet to enable “on-body” collection. When incorporating blood microsampling into a decentralized trial with the aim of improving trial efficiency and patient-centricity, it is essential that data quality remains uncompromised. Consequently, the choice of device is crucial for deriving accurate and precise drug concentrations whilst minimizing collection errors, particularly for compromised patient populations tasked with self-sampling. Therefore, the current overview considers the advantages for collection with each of the aforementioned microsamplers, and proposes detailed strategies for device selection based upon key bioanalytical assessments imperative in establishing suitability for regulated drug quantitation. Additionally, a device-independent extraction workflow is described that eliminates potential hematocrit-induced recovery bias.
Learning Objectives:
Discuss the general pro's and con's of several microsampling devices currently available for volumetric blood collection.
Design critical experiments to derive bioanalytical performance attributes that aid in microsampling device selection.
Leverage a generic sample processing workflow for accurate and precise drug quantitation.
Identify necessary method validation assessments unique to a blood microsampling workflow