Mitra® Device Collection Kit (Procedure Pack)

Importance of the Topic

Capillary microsampling by volumetric absorptive microsampling (VAMS®) enables minimally invasive collection of fixed-volume whole blood samples. This approach supports decentralized sampling, reduces patient discomfort and biohazard risk, and simplifies logistics by eliminating the need for cold-chain transport.

Objectives and Overview

This document details the design and use of the Mitra® Device Collection Kit, a single‐use, nonsterile pack for the collection, storage and transport of capillary blood specimens in precise volumes (10, 20 or 30 µL). It outlines step-by-step instructions, performance specifications and safety considerations.

Methodology and Used Instrumentation

• Kit components: Mitra® Device with 1–4 VAMS® sampler tips, lancets, gauze pads, adhesive bandages, desiccant pouch, specimen bag, sample ID barcode and plastic shipping envelope
• Sampling procedure: hand washing and warming, selection of lateral fingertip sites, lancet puncture, removal of first blood drop, timed contact of sampler tips (2 s per tip) directed downward until fully red, repeat for each tip, device closure by snapping flaps together
• Key performance parameters: volumetric precision < 5 % RSD, sample stability at up to 30 °C (short-term up to 45 °C), kit shelf life 18 months

Main Findings and Discussion

The standardized protocol ensures complete tip filling and prevents under- or over-sampling by controlling tip orientation and dwell time. Troubleshooting guidelines address low blood flow (hand warming, finger massage, new lancet), premature tip removal and excessive bleeding. Proper device closure and inclusion of desiccant maintain sample integrity during transport.

Benefits and Practical Applications

• Allows healthcare professionals and lay users to collect volumetric blood samples outside clinical settings
• Minimizes invasiveness and reduces sharps and spill risk
• Facilitates clinical trials, therapeutic drug monitoring, remote diagnostics and biobanking
• Simplifies shipping without refrigeration and streamlines sample tracking via barcode

Future Trends and Opportunities

Emerging developments include integration of digital sample identifiers, advanced polymer chemistries for enhanced analyte stability, high-throughput automated extraction platforms, and regulatory harmonization for broader diagnostic adoption. Potential applications span home-based monitoring, community health initiatives and integration with wearable devices.

Conclusion

The Mitra® VAMS® collection kit offers a reliable, user-friendly solution for precise capillary blood sampling. Its validated performance, clear instructions and streamlined logistics support expanded access to decentralized bioanalysis and remote healthcare monitoring.

Reference

No references provided.