blood-microsampling-applications-pediatrics

make pediatric studies easier for everyone

 

Children (and Researchers) Prefer Remote Specimen Collection & Microsampling

In the US, use of the Mitra device with blood is limited to research and non-diagnostic applications. In the US, the device is not for use with saliva samples intended for clinical DNA testing. In many countries outside the US, the Mitra device is approved as a remote blood sample collection device for some clinical applications, as referenced in some content included here.

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A needless blood sampling option for pediatric patients

At-home Specimen Collection Makes
Study Participation Easier

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.

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pediatric-capillary-blood-microsampling-case-studies

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:

  • With home sampling, children and their caregivers can skip the drive to and from the facility for blood draws
  • Mitra® devices with VAMS® technology are used for remote blood collection to monitor therapeutic drugs and malnutrition
  • Garner the logistical benefits of using Mitra® devices vs. DBS cards in low-resource regions around the globe
  • Simplify blood collection in pediatric study subjects by switching to at-home finger-prick sampling to reduce needle anxiety

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Mitra® is an exempt medical device in the US, CE-IVD self-certified in the UK and EU, a Class 1 IVD in Australia, and registered with Health Canada. It is intended as a specimen collector and for the storage and transport of biological fluids. Use of the device with blood for diagnostic applications is limited to certain countries and, in the US, for research and non-diagnostic purposes only. In the US, the device is not for use with saliva samples intended for clinical DNA testing. Neoteryx Products are not marketed in the US for clinical diagnostic uses. In other countries, Neoteryx Products 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.
 
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