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In the US, use of the Mitra device with blood is limited to research and non-diagnostic applications. In many countries outside the US, the Mitra device is approved as a remote blood sample collection device for some clinical applications, as referenced in some content.

how microsampling improves clinical research

by Neoteryx | 3 min read

shutterstock_1014984946-1Microsampling is a method of specimen collection that allows nearly anyone to collect tiny (or “micro-sized”) specimen samples for lab analysis. Microsampling is suitable for remote specimen collection for decentralized studies, and it has been gaining traction in the research field for several years. The use of remote microsampling surged in 2020 as the Coronavirus Pandemic forced people to shelter at home and avoid onsite visits. Microsampling had a big impact on clinical research in 2020, and is poised to have a big impact on healthcare moving forward.

How Does Microsampling Work?

Microsampling is an extremely user-friendly process that uses portable technology like Mitra® devices to decentralize sample collection. These devices can be used by researchers out in the field or by study participants at home to collect small amounts of biological fluids like blood, urine, or sweat.

First, the devices are typically included in kits that are sent to clinical research participants by research coordinators when a sample is needed. The participant unpackages the device and reads the instructions included with the kit. A very small lancet is included to pierce the skin on a fingertip if a blood microsample is required as part of the study.

The study participant uses a small Mitra device with an absorptive tip to collect a sample of biological fluid, gently touching the tip into the fluid until the device absorbs it. Following the instructions ensures the sample will furnish the precise volume needed to provide data to the research team. The filled device can be repackaged in the provided pouch 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. Study volunteers often have to take time off work or school to attend each clinic visit.

Remote sample collection makes it possible for people to participate in clinical trials from home. With user-friendly Mitra devices, a sample collection procedure can be performed much more quickly than traditional sampling, so study participants can complete the process in just a few minutes. 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 far larger geographic area than was previously possible.

Comfort

Specimen collection can be a daunting experience for many people. Some people are understandably frightened when confronted with 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 doesn't involve big needles. It is minimally invasive, virtually painless, uses a tiny non-threatening lancet, and it 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 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 usually 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, remote microsampling can often be done on a much smaller budget than conventional onsite sampling.

Improved Safety and Consistency

Because microsampling extracts a very small sample from the study participant, it is safer to use on high-risk patients (particularly when blood is being extracted) 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, the biofluid sample can be easily collected properly and safely returned to researchers and labs for analysis.

No Cold-Shipping Required

Unlike traditional sample collection techniques, remote sample collection using Mitra devices does not require the sample to be shipped in refrigerated conditions. 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 envelope. They then mail the microsample back to the laboratory using regular 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 communication options like email, telephone calls, and video chats) streamlines the traditional clinical research process and makes participation far easier for volunteers.

Pharmaceutical companies can use it 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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Originally published Mar 15, 2021 9:00:00 AM, updated on March 15, 2021

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