Guanidine-Free Molecular Transport Medium Improves COVID-19 Testing Safety

By LabMedica International staff writers
Posted on 13 Sep 2022

Image: MagXtract Collection Tube has received 510(k) clearance and CE Mark for COVID-19 testing (Photo courtesy of MagBio)

The US FDA has advised laboratory staff at COVID-19 sample processing facilities to avoid collection devices that use guanidine-based mediums because when cleaned with bleach, it creates cyanide gas that is highly toxic and can also be fatal. Now, the first ever guanidine free sample collection and transportation device with FDA 510(K) clearance and CE/IVDR marking certification makes it safe for use in clinical settings that require cleaning with bleach on a regular basis.

MagBio Genomics, Inc. (Gaithersburg, MD, USA) has announced US FDA 510(k) clearance, CE Mark approval and global launch of its MagXtract Collection Tube which offers improved safety, stability and cost-effective sample collection and processing. Used for sample collection and processing, the MagXtract Collection Tube is the first guanidine-free molecular transport medium, FDA-cleared device available in the U.S. for COVID-19 testing. In Europe the MagXtract Collection Tube is versatile, available for testing both COVID-19 and Influenza. It is also validated for bacterial and fungal sample collection and stabilization in research studies.

The MagXtract Collection Tube can stabilize DNA & RNA at ambient temperatures and contains a proprietary molecular transport medium which lyses and inactivates collected samples. Direct lysis of the sample effectively stabilizes the nucleic acids (DNA & RNA) making them available for capture without the need of an additional lysis step. Furthermore, direct pathogen lysis eliminates the need for sample processing in a containment, making it easier for laboratory staff to handle samples. The long term ambient stability of DNA & RNA offered by the MagXtract Collection Tubes makes them suitable for clinical settings since it eliminates the need for freezer storage space. Samples can be stored at ambient temperature on the bench top for up to eight days for RNA and 45 days for DNA.

“Accurate detection of pathogens by molecular assays depends on proper collection and stabilization of samples. Poor sample stabilization results in nucleic acid degradation and overgrowth of some micro-organisms, which may lead to patient misdiagnosis,” said Hyacinth K. Ntchobo, Ph.D., CEO, MagBio Genomics. “The MagXtract Collection Tube addresses these issues by providing cost-effective room temperature sample transportation and nucleic acid stabilization over prolonged time, providing clinical laboratories with high-quality samples for accurate molecular detection of pathogens.”

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MagBio Genomics, Inc.