Exploring VAMS Blood Sampling For The Potential of Tacrolimus TDM At-Home
The Mitra Microsampler class I medical device is for direct specimen collection of blood and other biological fluids. It is not specific to any clinical test, and is not for use in diagnostic procedures. Use of the Mitra Microsampler in Laboratory Developed Tests (LDTs) requires further processing including the establishment of performance characteristics and successful validation by the laboratory in a manner consistent with CLIA requirements.
Examine the potential of using the Mitra microsampler for at-home TDM. These finding present a novel opportunity of making the patient experience less disruptive while reducing the cost of health services.
Highlights of this research include:
Excellent linearity and precision for calibration curve of extractions from microsampling device (R=0.993)
Simple organic and protein precipitation clean-up methods
Strong correlation (R2 = 0.9536) between dried blood microsampling and wet blood samples
Mitra devices are intended as a specimen collector and for the storage and transport of biological fluids. They 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. Neoteryx operates a Quality Management System (QMS) that is based on FDA good manufacturing practices, 21 CFR 820 regulations, and ISO-13485.