total RNA/DNA purification and detection from blood preserved on a Mitra microsampling device
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.
Read this investigative study paper to learn how the isolated RNA and DNA were of the highest quality and all nucleic acids purified were successfully used in a variety of downstream molecular tests.
Highlights of this research include:
Both total RNA (large mRNA and microRNA) as well total DNA were shown to be preserved in the Mitra device
qPCR and Sanger sequencing for DNA as well as RT-qPCR and Next Gen Sequencing for RNA were analyzed
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.