Torrance, CA (May 10, 2016) – Neoteryx LLC announced today that the patent pending Mitra® Microsampling Device for the collection, transport, and storage of biological fluids is now available in a 20 µL sample collection volume. This expands the Mitra portfolio to now include both 10 µL and 20 µL microsampling devices to meet lower sensitivity requirements of bioanalytical assays.
This new device, based on Volumetric Absorptive Microsampling (VAMS™) technology, accurately and reliably collects 20 µL of blood (or other biological fluid) in seconds, while eliminating the volumetric hematocrit bias typically associated with the dried blood spotting technique. Once the sample is collected, the Mitra Microsampler is dried, stored, and transported under ambient conditions eliminating the need for laborious plasma processing steps and costly dry ice/courier transportation. For labs to prepare samples for analysis, an automatable extraction with common solvents is performed.
“The 20 µL device was primarily developed to meet the needs of organizations that have more stringent sensitivity requirements for their pharmaceutical or clinical reserch assays”, says Kim Chansky, Senior Strategic Partnership and Product Manager. “This new device delivers greater sensitivity than the 10 µL version, which allows microsampling to be used for analytes in very low concentrations, or with older and less sensitive mass spectrometry instruments.”
The CE/IVD and FDA Class 1 listed 20 µL Mitra Microsampling Device, which is currently available in four formats, is suitable for biological sample collection in the pharmaceutical, clinical, and research environments. The 96-rack and 96-autorack are recommended for method development and semi-automated / automated sample extraction processing. The clamshell format, available with 2, 3 or 4 microsamplers, is an economical option for direct patient sampling whereas the cartridge format is a more elegant solution for direct-patient and/or at-home sampling as it includes barcodes for managing chain-of-custody as well as a re-sealable bag and desiccant for shipping samples to the lab.
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.