In the US, use of the Mitra device is limited to research and non-diagnostic applications. In many countries outside the US, the Mitra device can be used as a sample collection device for clinical diagnostic applications, as referenced in some content included here.
Children can find visits to a research facility stressful. This poses challenges for researchers and trial managers who rely on collecting bio-fluid specimens to monitor pediatric study subjects. One solution is to offer remote specimen collection, which reduces or eliminates onsite visits. Remote specimen collection can be performed by parents or another family member at home, which makes the process less stressful. The Mitra® Microsampler is a portable device designed for easy sampling at home or on the go. Samples can be mailed back to the facility via regular post for lab analysis. This remote option provides a better experience for young study participants and their families, and a convenient way for researchers to gather the high-quality samples they need to generate reliable data.
Learn more about the remarkable results already being achieved by researchers at Gaslini Children's Hospital, Swiss Tropical and Public Health Institute, and others. Some case studies offered here for download discuss healthcare projects in countries outside the US, where Mitra® devices are approved for blood collection in clinical settings:
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Mitra® devices are CE-IVD (IVDR) devices intended as specimen collectors and for the storage and transport of dried blood. They are available as registered IVD Devices in the European Union and United Kingdom, Australia, Brazil, China, and Canada, as well as multiple Health Ministries worldwide. In the USA, Mitra devices are supplied as a research use only (RUO) product to assist in method development, other research-related and non-diagnostic activities. Mitra has not been validated for use with any diagnostic testing.
hemaPEN® variants are CE-IVD (IVDR) devices intended as specimen collectors, for the storage and transport of dried blood specimens and are available as registered IVD Devices in the European Union and United Kingdom, Australia/New Zealand, and the USA. Outside of these territories, the hemaPEN is supplied for research use only (RUO).
The Harpera™ skin microbiopsy tool is currently supplied as an investigational use only (IUO) product globally.