Newsroom / COVID-19 tests

In the US, use of the Mitra device with blood is limited to research and non-diagnostic applications. 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 of the news content posted here.

Quanterix Publishes Study Paper on High-Sensitivity SARS-CoV-2 Test

by Neoteryx, on April 22,2021

Quanterix Publishes Study Paper on High-Sensitivity SARS-CoV-2 Test

At the end of March 2021, Quanterix Corporation issued a press release announcing that its Simoa® technology had been used in a research study to detect the SARS-CoV-2 virus. According …

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LGC COVID-19 Antibody Assay Processes up to 40,000 Tests Per Day in UK

by Neoteryx, on September 23,2020

LGC COVID-19 Antibody Assay Processes up to 40,000 Tests Per Day in UK

LOS ANGELES and Cambridge, UK — September 2020 — The first commercially available SARS-CoV-2 antibody test in the UK compatible with Neoteryx’s Mitra® Microsampling device for at-home blood collection has …

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COVID-19 Tests? Consider a Finger-Prick Instead of a Regular Blood Draw

by Neoteryx, on April 29,2020

COVID-19 Tests? Consider a Finger-Prick Instead of a Regular Blood Draw

“COVID-19 testing is top-of-mind for every researcher around the world at present, and effective testing is an important part of every coronavirus pandemic safety plan. Testing can potentially be done …

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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. 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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