3rd March 2020 Author: Paul Carton
FDA Entrusts Longhorn's Viral Transport Medium To Protect Suspected SARS-CoV-2 Samples
If COVID-19 diagnostic kit manufacturers are applying for emergency use authorization (EUA) they should use Longhorn's PrimerStore MTM® as the viral transport medium and declare this on the application; this will allow the kits to be used in CLIA labs while the EUA is in process, the FDA has said.
Currently, Covid-19 assays approved for EUA with viral transport medium must be run in Biosafety level (BSL) 3 or 4 laboratories. However, the PrimerStore MTM sample collection device developed by Longhorn Vaccines and Diagnostics deactivates pathogens at the point of collection, stabilizes RNA and DNA and does not require special containment facilities, normally needed to deactivate the virus. This allows samples to be run in BSL 1 & 2 laboratories.
If companies have already applied for EUA, they can send on a supplement using PrimeStore MTM, which allows it to be used by CLIA laboratories.
PrimeStore MTM was first authorized in 2009 by the FDA as a component of a complete molecular diagnostic kit, as part of the agency’s H1N1-09 Influenza Pandemic Emergency Use Authorization.
PrimeStore MTM (Molecule Transport Medium) is the first and only microbial nucleic acid storage and transport device cleared by the US Food and Drug Administration (US FDA). It is indicated to rapidly inactivate viruses (including Influenza), bacteria (including Mycobacterium tuberculosis) and high consequence veterinary pathogens (including ASFv, CSFv, FMDv, HPAI, NDv) within the sample and stabilize the RNA and DNA to provide a safer and more efficient workflow for molecular testing and sequencing.
Date Published: 3rd March 2020
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