I am a student of the University of Minnesota Twin Cities studying biomedical engineering and management. I am working with a team of other engineering students and a pediatrician to prototype a system for at home testing of Tacrolimus levels. If anyone that takes Tacrolimus would be willing to answer any of the following questions, it would be immensely helpful in the development of the kit. Thank you!
(a) What do you need and/or want out of an at home Tacrolimus testing kit?
(b) How much would you be willing to pay for at home Tacrolimus testing kit?
(c) What product/services are currently used to monitor your Tacrolimus levels?
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comoblue
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a. Ease of use (finger prick like glucose test?) It might also be good to know why I would want to do this at home. Is once a week not often enough, or is this just so I wouldn't have to go to the lab as often.
b. Since my labs are covered, I wouldn't want to pay much, it saves a bit on time and gas, but is that worth it?
1) Would likely need to be a blood test - says it would be cool if done with saliva. It would also be cool, as another poster indicated, if it included additional info such as creatinine.
2) Would need to be eligible for insurance coverage since transplant related labs he currently gets are fully covered.
3) Currently using lab service (LabCorp) in town with standing orders on file from transplant center located two hours away. Results shared with all interested parties.
I get my tacrolimus level at the same time that I get the rest of my labs so wouldn’t be that helpful for me. Sorry! Sounds like an interesting project!😊
I would agree with most people, while tac would be nice it is the least important for most of us with transplants. Creatinine, BUN, or even another marker like NGAL, cystatin c, or KIM1 would be better. Of course, the last three have yet to be FDA approved for diagnostic purposes.
I worked on the development of a creatinine, tacrolimus, and cyclosporin at-home test kit or point of care (POC) about 12 years ago. The technology has advanced a lot, but one of the limitations has always been the ELISA kits for Tac and CsA have a very poor lower limit of quantitation and usually sit right on the edge of "normal" levels for tacrolimus and cyclosporin for most patients. In fact, our lab was one of the few in the country for a long time that had a validated mass spectrometry technique for the measurement of immunosuppressants for clinical diagnostics. We received hundreds of samples from the local transplant facilities to quantitate Tac, CsA, Srl, Evr, and MMF and we also tested samples from across the world for clinical samples that fell outside the range of ELISA kits used by other labs.
Creatinine is difficult to measure with a POC measurement with current assays because they are colorimetric and require serum/plasma to remove the red blood cells or there is interference in the assay. While urinary creatinine can overcome this problem, urinary creatinine is not as reliable as serum/plasma.
We ended up working on the idea that blood spot analysis via mass spec would be a better alternative given the limitations (first paper link). You would essentially prick your finger and put a drop of blood on a filter paper and mail it to the lab.
There is another group working on the combined tacrolimus + creatinine using blood spot analysis with mass spec as well (see second paper).
As someone who has lived in the middle of nowhere, I would be more than happy to use a mail-based system that could be done more frequently, rather than needing to drive 1-2 hours to the lab, and then sit around for another hour to have my blood drawn every month, especially when you need to get trough levels done and need to be at the lab before 8 AM! Not to mention one of my big pet peeves about the medical system is the inflexibility in operating hours to get testing done. When I worked hourly jobs I had to take time off work to get blood draws done, which eats into your PTO quickly.
Feel free to message me if you have any questions.
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