Mitra® Device Collection Kit (RUO)

Importance of topic

The ability to collect precise volumes of capillary blood in remote or resource-limited settings is crucial for research and diagnostic applications. Volumetric absorptive microsampling (VAMS) using the Mitra® device facilitates stable, accurate, and minimally invasive sampling without the need for cold chain transport, improving patient compliance and logistical efficiency.

Aims and overview

This document outlines the procedure for using the Mitra® Device Collection Kit (RUO) to collect, store, and transport capillary whole blood specimens of 10, 20, or 30 µL volumes. The kit is intended for research use only (RUO) and supports standardization of sampling workflows across healthcare professionals and lay users.

Methodology and instrumentation

The kit contains:

• Mitra® device housing up to four VAMS® sampler tips (hydrophilic porous polymer)
• Lancets (2 or 4 units)
• Silver specimen bag with desiccant
• Gauze pads (1 or 2)
• Adhesive bandages (2 or 4)
• Sample ID barcode label
• Plastic shipping envelope (pre-addressed)

Key steps:

1. Unpack kit and prepare lancets, sampler tips, gauze, and bandages.
2. Wash and warm hands to promote blood flow.
3. Select and clean the finger; prick with lancet until a click is heard.
4. Wipe away the first blood drop; gently massage finger to form a second drop.
5. Touch sampler tip to drop until fully red; hold for 2 s and repeat for each tip.
6. Ensure tips are filled correctly (no white shows) and avoid dripping blood from above.
7. Close device until it clicks, seal in specimen bag with desiccant, then ship in envelope.

Main results and discussion

Volumetric sampling using VAMS tips delivers high precision (< 5 % RSD) and reproducibility. Over- and under-sampling can be mitigated by correct tip orientation and timing. Ambient storage up to 30 °C (short-term up to 45 °C) and an 18-month shelf life enhance sample stability and workflow flexibility.

Benefits and practical applications

• Minimally invasive and user-friendly capillary blood collection
• Defined volumetric sampling (10–30 µL) for pharmacokinetic and biomarker studies
• Elimination of cold chain; simplified logistics and storage
• Compatibility with standard lab assays after dried sample extraction
• Suitability for decentralized clinical trials and home sampling

Future trends and potential applications

Integration with digital sample tracking and telehealth platforms will expand decentralised research and diagnostics. Advances may include automated tip-to-analysis interfaces, application to other biofluids (e.g. saliva), and further miniaturisation for multi-analyte panels.

Conclusion

The Mitra® Device Collection Kit provides a robust, reproducible method for volumetric microsampling of capillary blood in research settings. Its ease of use, ambient storage capability, and high volumetric precision make it an attractive tool for decentralized studies and future diagnostic applications.