how microsampling improves clinical research

Microsampling is a method used for blood collection that allows nearly anyone to collect tiny, “micro-sized,” blood samples for lab analysis. Microsampling is a suitable blood collection method for remote research studies or decentralized clinical trials. It has been gaining traction in the research field for several years but accelerated in 2020.

Remote microsampling surged as the Coronavirus Pandemic forced people to shelter at home and avoid onsite visits to crowded medical or research facilities. Since 2020, microsampling for remote blood collection has been on an upward trend and is poised to change the way we think about "having bloodwork done" for health care or research studies moving forward.

How does microsampling work?

Microsampling is a user-friendly process that relies on portable technology like DBS cards, or volumetric microsampling tools like the Mitra^® device or hemaPEN^® to enable remote sample collection. These devices can be used by researchers conducting field studies or by study participants at home to collect low-volume samples of blood from a simple finger-stick.

Microsampling devices are included in sample collection kits that are sent to patients or clinical research participants by research coordinators. Device formats and kit components may vary slightly, depending on the type of study being conducted or the region it is in.

The participant unpacks the device and sampling supplies, reads the instructions included with the kit, and self-collects small blood samples using a finger-stick method. A small lancet is provided to pierce the skin on a fingertip.

The study participant uses a Mitra device, which has an absorptive sponge tip, to collect a sample of blood by gently touching the device tip to the blood drop on the finger until it absorbs into the tip.

Following the instructions ensures the collected samples will furnish the precise volume needed by the research team to generate reliable data. The filled device can be repackaged in its foil specimen pouch and the provided envelope and mailed to the researchers for analysis.

Microsampling Drives Improvements in Clinical Research

Remote specimen collection and microsampling allow clinical studies to be run in an entirely new way. Some of the benefits it can bring include:

Convenience

Traditional clinical studies require participants to make dozens of onsite visits over the course of a single study, usually for blood draws and lab tests. Study volunteers often have to take time off work or school to attend each clinic or lab visit.

Remote sample collection makes it possible for people to participate in clinical trials from home, without disrupting their busy schedules. With portable and user-friendly Mitra devices, a self-guided blood sample collection procedure can performed at home or work. This approach is quicker and more convenient than a venous blood draw performed by a trained phlebotomist in a lab or clinic setting.

Not only do study volunteers greatly appreciate the convenience and flexibility of remote sampling, this approach also helps researchers recruit potential trial participants from a wider geographic area than was previously possible.

Comfort

Blood draws can be a daunting experience for many people. Some people are understandably frightened at the sight of a needle for a blood draw.

This is especially true if their veins are small or hard to find, and if they’ve previously experienced a blood draw where the nurse or phlebotomist had to make several attempts to puncture a vein to draw blood.

Remote microsampling with the Mitra device or hemaPEN is done using a finger-stick method and doesn't involve big needles. It is minimally invasive, virtually painless, utilizes a tiny non-threatening lancet, and can be performed at home or in another familiar environment.

When specimen sampling is so easy and convenient, it makes participation in a clinical trial much more feasible and comfortable for many people.

Remote microsampling is likely to increase volunteer recruitment rates for clinical trials that contribute to vital medical research.

Cost Savings

Microsampling devices are relatively inexpensive and easy to use, and don’t require the assistance of a medical professional or a dedicated space for specimen collection. Once remote microsamples are received in the lab via mail, they can be analyzed using the standard lab equipment most institutions already have available. This eliminates the potential expense of acquiring new equipment.

When all these savings are added up, you can see that remote microsampling helps to reduce the overall budget for a research study or clinical trial.

For a visual comparison of how to reduce overall clinical trial costs by replacing conventional onsite blood sampling with remote microsampling, view our infographic on using microsampling in a Decentralized Clinical Trial.

Improved Safety and Consistency

Because microsampling extracts a very small sample from the study participant, it is safer to use on young or particularly vulnerable populations and provides a more consistently useful sample volume.

A Mitra^® microsampling device is based on VAMS^® technology, which makes it easier for anyone to collect a precise volume of biofluid. Mitra devices are designed to make the sample collection process nearly foolproof, even in the hands of inexperienced users.

As long as study volunteers or their caregivers can read simple instructions and follow a set of diagrams or an online video, the blood sample can be easily collected properly and safely returned to researchers and labs for analysis.

No Cold-Shipping Required

Unlike traditional liquid sample processing, remote microsamples collected using Mitra devices do not require shipping in dry ice or refrigerated conditions. Microsamples can be sent via standard mail at ambient temperatures and will be analyzed as dried blood samples. This drastically simplifies the process and reduces associated costs as well.

After study participants collect their samples using one of the Mitra devices, they simply keep it inside its protective plastic case, repackage it in the included sealable pouch, and pop that inside a provided mailing envelope. They drop that in the nearest mailbox to send the microsample back to the laboratory via standard mail services.

Microsampling Makes Clinical Research Easier

Remote microsampling can provide enormous utility to researchers conducting clinical trials. This advanced yet simple sample collection method (especially when combined with remote telehealth communications via email, telephone calls, and video chats) streamlines the traditional clinical research process and makes participation far easier for volunteers.

Pharmaceutical companies can use this approach to run more effective clinical trials with greater efficiency and at a lower cost. Microsampling produces measurable and invaluable improvements in every aspect of the clinical research process.

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