microsampling in clinical trials

Yes, volumetric microsampling devices have been used in many clinical trials around the world. Our Technical Resource Library includes a searchable selection of published literature discussing studies and trials that applied remote specimen collection and volumetric microsampling. Type "trial" or your analyte of interest in the library's search field to find journal articles, presentations and application notes.

Many analytes can be extracted using volumetric microsampling, and are compatible with hemaPEN^® and Mitra^® devices with VAMS^® technology. Our Technical Resource Library provides information around the types of analytes that have been evaluated by researchers using volumetric microsampling. Type your analyte of interest in our Technical Resource Library search field to find the information you seek. 

Sample success rates are high for Mitra^® and hemaPEN^® devices, which are based on volumetric microsampling. The absorptive VAMS^® tips on Mitra can absorb homogenous samples with 99% acceptance rates.* By following the illustrated instructions and demo videos available with hemaPEN and Mitra, end-users can reliably collect fixed volume samples that are precise enough for lab analysis.

These volumetric microsampling devices overcome the hematocrit (HCT) bias that may occur with DBS cards, where non-homogenous blood spots on filter paper have higher variability and higher failure rates.*

*Data on sample success rates are discussed in published research articles in our online Microsampling Resource Library.

Example: https://www.medrxiv.org/content/10.1101/2021.01.27.21250570v1.full

Published research papers show that dried capillary whole blood microsamples collected in 10, 20, or 30 µL volumes are enough for good extraction and analysis. These samples also yield high-quality data that are similar to data from venous blood. The literature provides case examples of microsampling in research applications. Visit the Technical Resource Library to review many comparative studies that describe what others have achieved with microsampling in their research.

The first step in transitioning from other sampling methods to microsampling is an introductory, initial education phase, which may take about 4 weeks. The next steps involve evaluation and validation. The Neoteryx Microsampling Team and Technical Director can provide support through all the steps:

Education: The introductory phase 

Evaluation: Extraction, linearity & signal-to-noise studies

Validation: Validating your method

See our Microsampling User Guide for details.

While we are exploring this capability as a future advance in the microsampling industry, traditional wet blood samples and conventional phlebotomy are still used for most standard health panels and the complete blood count (CBC). 

Dried blood sampling (e.g., using Mitra, hemaPEN or DBS cards) eliminates the requirement & expense of a certified phlebotomist to perform the blood sample collection. In addition, the shipping of dried blood samples to a central laboratory doesn’t require costly cold-chain shipping supplies/methods, but instead can be shipped via standard post.