Thanks to advances in laboratory technology, it is now possible to generate a large amount of data from a small amount of biological fluid. If appropriately collected, samples as small as 30 or 40 μL can yield enormous amounts of information. The process of collecting these small samples of blood, urine, or other such material is called micro-sampling. Here’s a short discussion on the ins and outs of operating a micro-sampling laboratory with Tim Drapeau, president of US Specialty Labs.
What made you decide to start a micro-sampling laboratory?
We opened our lab with a goal of finding ways to provide consumers easier access to laboratory testing, and therefore, become able to take more control over their health. After looking around at the options available at the time, we arrived at the use of self-collected fingerstick samples—specifically serum separator cards—as the platform to make this happen. Shortly thereafter, the wave of consumer-direct online laboratories began to take shape. After making the investment to validate more than 40 different assays, we began to reach out to the major players in that space and have been working with many of them since 2017.
Where are you now in the process?
It has been an exciting time for the team. We have continued to expand our menu and testing platforms and anticipate processing close to 10,000 samples during September 2019. Over the past two years, we have also assisted multiple IVD manufacturers on new blood collection devices—one of them receiving FDA clearance this past month and another involving the collection of menstrual blood. We obtained CAP accreditation in 2017, just passed our 2019 inspection, and were also part of a peer-reviewed study comparing fingerstick and venipuncture results for a series of fertility hormones that was published in Obstetrics and Gynecology earlier this year.
What was the hardest part of starting a micro-sampling lab – equipment, finances, people, or technology?
Everything we have done has been self-funded. While we did have to pace ourselves in the early going, we feel having access to a bit more time allowed us to explore ways to do more with less. Initially, the most challenging part was working towards the breakthroughs we made regarding the processing methods and corrective factors for the reconstituted samples. With that behind us, along with increasing the number of validated assays, we have been tightly focused on refining the processes such that we can perform more tests out of a single card.
Are you finding any differences between starting a traditional reference lab and over micro-sampling lab?
Yes, in addition to the more complex pre-analytical work and the validation process requiring additional samples to ensure accurate development of corrective factors, due to the actions taken by a few competitors, there is much more scrutiny on our processes and procedures than a regular reference lab. We decided pretty much on day one that we would be fully transparent and are happy to share the detailed and underlying validation data with prospective clients.
