Mitra® Device (IVD)

Significance of Topic

Accurate collection of small volumes of blood or biological fluids is critical for reliable diagnostic testing, pharmacokinetic studies and remote patient monitoring. Volumetric absorptive microsampling reduces the need for venous draws, lowers biohazard risk during transport, and stabilizes samples at ambient temperature for extended periods. Such miniaturized sampling strategies enable decentralized care and broaden access to laboratory testing.

Objectives and Overview

This document provides clear step-by-step guidance on using the Mitra volumetric absorptive microsampling device for collection, storage and transport of dried whole blood. It covers device configurations, key handling techniques to ensure consistent sample volumes, troubleshooting of common errors and proper packaging to maintain sample integrity during shipping.

Methodology and Instrumentation

The Mitra device employs polymeric tips calibrated to collect fixed volumes (10, 20 or 30 µL). Sample collection proceeds in seven stages:

• Optional unpacking of device from protective silver specimen bag.
• Opening device flaps to expose up to four sampling tips.
• Touching each tip to a fresh drop of capillary blood until it turns fully red (no visible white).
• Repeating tip contact to achieve complete saturation without submerging or dripping blood.
• Verifying all tips are uniformly red to confirm full volumetric uptake.
• Closing housing with an audible click to secure samplers.
• Sealing the device inside the provided desiccant-containing bag for transport.

Použitá instrumentace

• Mitra volumetric absorptive microsampling device (single or specimen bag configuration)
• Contact-activated lancet (1.5 mm × 2 mm cut for adults; 1.0 mm × 2 mm for vulnerable subjects)
• Gauze pad, adhesive bandage
• Specimen bag with desiccant and zipper closure

Main Results and Discussion

Proper technique yields precision under 5% RSD and reproducible sample volumes across multiple tips. Under-sampling often stems from premature tip removal or cessation of blood flow, while over-sampling occurs when blood drips onto the tip. Clear visual cues and timed contact (2 seconds) mitigate these errors. Packing samples immediately in desiccant ensures moisture control and analyte stability during a shelf life of up to 18 months.

Benefits and Practical Application

• Enables capillary blood collection by non-specialists without laboratory facilities
• Improves sample stability and reduces cold-chain requirements
• Minimizes biohazard risk during mailing or courier transport
• Supports decentralized clinical trials and point-of-care testing

Future Trends and Potential Applications

Advances may include integration of microsample collection with smartphone-based barcoding and digital tracking, expansion into collection of other matrices such as saliva or interstitial fluid, and development of compatible automated sample preparation workflows. Emerging high-throughput analytical platforms will further leverage microsampling for large-scale population studies and remote therapeutic monitoring.

Conclusion

The Mitra device provides a robust, user-friendly approach to volumetric microsampling of blood with high precision and simplified logistics. Adherence to the outlined steps and packaging guidelines ensures reliable sample quality, enabling wide adoption in clinical, research and industrial environments.

Reference

No external literature cited.