top 5 questions about microsampling implementation
by Neoteryx, on Aug 4, 2017 6:16:00 AM
For those curious about what microsampling is and how it works, we have many resources available here on the blog, in our growing resource library, and on our FAQ page. However, when the time comes to actually use this technology, more complex questions often arise.
In our work helping large and small organizations adopt breakthrough microsampling technology, we've witnessed recurrent patterns in what sorts of questions are salient. Thus, we'd like to take a minute and address some frequent concerns many initially face about microsampling.
Does dried capillary blood correlate to wet venous blood? And Is 10 or 20 µL enough?
Ample research shows that dried blood microsamples from a fingerstick can yield quality results which correlate to or may even match values from traditional blood collection methods. The literature available is broad and shows the relevance of microliter volume specimens in clinical and preclinical applications. Download the VAMS™ publication list and review these comparative studies to see what others have achieved.
Have any organizations successfully implemented dried blood microsampling?
Yes. Prominent organizations, from academic research institutions to commercial clinical reference labs, are successfully deploying this nontraditional specimen collection technology. Examples include Cedars-Sinai, Exagen Diagnostics, Charles River Labs, and Quest Diagnostics
Is the Mitra Microsampler a registered medical device?
Yes, it is an FDA listed Class 1 device (D254956) as well as a registered CE IVD. Neoteryx complies with FDA good manufacturing practices, CFR 820 regulations, and ISO 13485.
Is Mitra microsampling more expensive than my current collection method?
On average, the cost is $2.50 per test, and initial validation requires an upfront investment of time and resources. However, any initial friction is well worth it. Mitra microsampling technology saves money (e.g., no cold-chain shipping or storage), labor (e.g., compatible with typical liquid handling instrumentation), and resources (e.g., use non-clinical staff to collect specimens) over time.This allows for future growth.
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.
- Education [1 - 2 weeks] The introductory phase is your opportunity to familiarize yourself with what can and can’t be done with dried blood microsamples
- Evaluation [4 - 6 weeks] In this second phase, a microsampling specialist will guide and support 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. Work closely with your microsampling specialist to plan for commercialization
Ready to move forward? Start your device evaluation today!