Fluispotter, a Novel Automated and Wearable Device for Accurate Volume Serial Dried Blood Spot Sampling

Abstract

Aim: A novel automated serial dried blood spot (DBS) sampler, ‘Fluispotter’, was tested for its sampling performance. Materials & methods: An LC–MS/MS method was developed for the analysis of cortisol in DBS samples serially spotted by Fluispotter. The cortisol concentrations in 148 paired DBS and plasma samples were compared across a hematocrit (HCT) range of 22–55%. Results: The interassay accuracy and precision were <10%. Overall assay bias was negligible across the HCTs tested when analyzing the whole-spot DBS samples. The accuracy and precision of the blood volume in 10 μl DBS samples spotted by Fluispotters and micropipettes were within 3%. Deming regression and Bland-Altman analysis showed a good agreement of DBS-predicted and measured plasma cortisol. Conclusion: The Fluispotter performed serial sampling with high accuracy and precision of the sample blood volume.

Evaluation of moxifloxacin in canine and non‐human primate telemetry assays: Comparison of QTc interval prolongation by timepoint and concentration‐QTc analysis

“…A key learning was that the inclusion of a separate PK arm on the back‐end of a telemetry study is needed for optimal C‐QTc data‐pairing in the same animals and is feasible for agents with reasonably short half‐lives (e.g., small molecules). The development of new methods that enable noninvasive collection of blood samples during the CV telemetry phase could mitigate the need to conduct two separate dosing sessions, and the potential to have inconsistent drug exposure in each session 53 . For agents with long half‐lives, PK sampling can be integrated into the telemetry phase, but taken on a nonrecording day to minimize disruptions in QTc data acquisition which would be preferred for PK/PD modeling.…”

“…The development of new methods that enable noninvasive collection of blood samples during the CV telemetry phase could mitigate the need to conduct two separate dosing sessions, and the potential to have inconsistent drug exposure in each session. 53 For agents with long half‐lives, PK sampling can be integrated into the telemetry phase, but taken on a nonrecording day to minimize disruptions in QTc data acquisition which would be preferred for PK/PD modeling.…”

Dried blood sample analysis by antibody array across the total testing process

“…The small volume decreases sensitivity and accuracy of quantitation, while non-uniform blood distribution across a DBS and changes in hematocrit levels can arise due to collection volume uncertainty. Non-homogeneity across a DBS sample have been addressed with a variety of approaches, including whole spot analysis and volumetric sampling 30 – 37 , 47 , 48 . We have developed a specially designed volumetric blood collection device which yields a sufficient quantity of sample to test any number of proteins in a multi-plex immunoassay, with bleeding capacity being the most significant limiting factor of sample volume.…”

Microsampling: A role to play in Covid‐19 diagnosis, surveillance, treatment and clinical trials

“…Haematocrit (Hct) and homogeneity are the most concerning factors for the analysis of dried blood samples 34–36 . Several developments are being made to overcome the volume‐based bias leading to various novel techniques like Hemaxis, 37 hemaPEN, 38 Capitainer‐B, 39 Volumetric Absorptive Microsampling (VAMS)‐Mitra samplers, 40 Volumetric Absorptive Paper Disc (VAPD) and mini‐disc (VAPDmini), 41 Solid‐Phase Microextraction (SPME), 42 Fluispotter 43 and Tasso‐device 44 . The challenges are being eliminated, and precise analytical results are being obtained with innovative detection techniques 45–48 .…”