Volumetric Absorptive Microsampling (VAMS®) is the technology behind our patient-friendly Mitra® devices, which are designed for remote specimen collection. VAMS retains the benefits of dried blood spot collection (DBS) cards while solving for their limitations. Overcome the hematocrit issue with Mitra and VAMS for easy and precise specimen collection, with reliable results.
Download these case studies from Exagen Diagnostics, GlaxoSmithKline, and others for details on how to achieve the following benefits vs DBS cards:
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When DBS cards debuted more than 50 years ago, they had significant advantages over traditional wet sampling, including simplicity, low cost, and ease of transportation.
Yet, adoption was hindered by regulatory concerns over the "Hematocrit (HCT) Effect" and automation limitations. In addition, incorrect spotting technique can lead to high sample rejection rates.
The FDA Class 1 Mitra® Microsampler is a remote specimen collection device that retains the advantages of DBS cards while overcoming their limitations.
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The Mitra Device is a single-use, non-sterile device used as a specimen collector and for the storage and transport of blood or other biological fluids. It is designed to be used by laboratory and healthcare professionals, or end-users as a container to collect and transport blood or 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 and/or other regulatory requirements.
The Mitra Microsampling Device is a FDA listed Class 1 exempt device, CE-IVD self-certified in the UK and EU, a Class I IVD in Australia, and registered with Health Canada. Neoteryx operates a Quality Management System (QMS) that is based on FDA good manufacturing practices, 21 CFR 820 regulations, and ISO-13485.
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