top 5 microsampling questions
by Neoteryx Microsampling on Dec 20, 2021 9:00:00 AM
If you are a researcher seeking to learn more about microsampling and how it works, you can find many resources to help you on the Neoteryx website.
Are you wondering if other research labs have successfully extracted analytes and processed dried specimens using microsampling devices? Our Technical Resource Library gives you access to more than 200 published articles from others who discuss their achievements using Mitra® devices with VAMS® technology for remote specimen collection and microsampling in research and medicine around the globe.
Microsampling: frequently asked questions
The microsampling team at Neoteryx has helped many large and small organizations adopt our original, patented VAMS technology for volumetric sampling in their research studies, clinical trials and public health programs. We saw wider adoption of microsampling in 2020-21 during the COVID-19 pandemic. When we speak with customers who are transitioning to volumetric absorptive microsampling with dried matrices, such as dried blood, urine and saliva, we find that a few questions come up frequently. Here we address the most frequently asked questions (FAQS) we hear from our customers about microsampling:
1. Does dried capillary blood correlate to wet venous blood? And Is 30µL or less enough?
Researchers around the world have adopted Mitra® devices with VAMS® for a broad range of applications, and many research papers show that capillary whole blood microsamples absorbed from a finger-stick onto a 10, 20, or 30 µL VAMS tip of a Mitra device can yield enough volume for good extraction and subsequent analysis. The Mitra devices also yield high-quality data that correlates to values from traditional venous blood collection methods. The literature available shows the relevance of microliter volume specimens in preclinical and clinical applications. Visit the Technical Resource Library on microsampling to review many comparative studies that describe what others have achieved in their research.
2. Have any organizations successfully implemented dried specimen microsampling?
Yes. Prominent organizations, from the National Institutes of Health (NIH) in the United States to the National Health Service (NHS) in the United Kingdom, academic research institutions and commercial labs, researchers and others at organizations around the world are successfully deploying Mitra devices with VAMS for remote specimen collection and microsampling projects. A few additional examples include Rennes University Hospital in France, Ghent University in Belgium, Nottingham Children's Hospital in England, Oslo University Hospital in Norway, the University of Bologna in Italy, and the University of Rochester Medical Center in the US.
The microsampling team at Neoteryx provides technical support to these organizations as they continue innovating and expanding their microsampling studies. Their tried and tested methods are outlined in a step-by-step Mitra Microsampling User Guide from Neoteryx, which you can access here.
3. Is the Mitra device with VAMS technology a registered medical device?
Yes, Mitra devices, which are intended as a specimen collector and for the storage and transport of biological fluids, are CE-IVD self-certified in the UK and EU, a Class 1 IVD in Australia, Brazil & China, Class B in South Africa, and registered with health agencies in Canada, Thailand, and Ukraine. In the United States, Mitra devices are for Research Use Only (RUO). In some countries, Mitra devices may be used in clinical diagnostic laboratory systems after the laboratory has validated their complete system in compliance with relevant rules and regulations.
4. Is Mitra microsampling more expensive than my current collection method?
Mitra devices start around US$ 2.50 per sample, and initial method validation requires an upfront investment of time and resources. Any initial investment in Mitra is well worth it. Mitra microsampling with VAMS technology saves money over time, because there is no need for cold-chain shipping or storage, no additional equipment purchase (Mitra with VAMS is compatible with most standard lab instrumentation), and no need to use up precious staff resources to collect specimen samples from individuals (specimen collection is typically self-managed at home or onsite by non-clinically trained staff).
Other dried-specimen collection methods (i.e., DBS) can have high sample failure rates that require resampling at added cost and inconvenience. However, the sample success rate for Mitra devices is quite high (typically 98%), and participant satisfaction with the finger-stick sampling approach is also good (typically 80% or higher). We find that these rates also help improve study participant compliance and retention. So, the overall cost savings with Mitra over time allows for realistic budget calculations and future growth.
5. How much time will it take to implement microsampling technology?
In our experience, the process to thoroughly explore the applicability of Mitra microsampling typically takes 6-8 months and is divided into three phases, with ongoing technical support from the Microsampling Team at Neoteryx:
- Education: [1 - 2 weeks] The introductory phase is your opportunity to familiarize yourself with what can and can’t be done with Mitra microsamples.
- Evaluation: [4 - 6 weeks] In this second phase, a microsampling specialist can guide you through extraction, linearity, and signal-to-noise studies.
- Validation: [6 - 8 months] In this final phase, you’ll perform a complete method validation including stability testing and correlation studies, conduct pilot studies in the field, and deploy lab automation workflows . Work closely with your microsampling specialist to plan for study implementation.
These phases and the associated steps are outlined via illustrated instructions in The Mitra Microsampling User Guide, which you can download here.
Ready to move forward? Reach out to our Microsampling Team to start your Mitra device evaluation today!
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