DxTM VIRAL TRANSPORT MEDIUM

Microbix’s DxTMTM Viral Transport Medium is a Canadian-made, proprietary IVD Medical Device that is designed for use in the collection and transport of specimens containing viruses, including SARS-CoV-2. The DxTM formulation is designed to stabilize available viral particles within a given sample. It is intended for collection and transport of clinical specimens containing viruses from the collection site to the testing clinical laboratory. DxTM TM is suitable for processing using standard procedures for viral nucleic acid testing.

DxTM is used primarily for transporting patient sample swabs or for transporting materials released into the medium from such swabs. Manufactured under our ISO 13485 Quality Management System, DxTM packaging tubes contain 3 ml of the medium, with the tubes able to accommodate 80 mm and 100 mm breakpoint swabs for transportation. DxTM facilitates collection and transport of samples in areas where refrigeration is not readily available, with validated ambient temperature storage and shipping an option (2-250C). The advanced formulation stabilizes viral components and suppresses microbial contamination. DxTM is also gamma-irradiated to meet aseptic requirements.

DxTM Viral Transport Medium is validated for viral nucleic acid testing. However, upon separate validation, it could potentially be used for viral antigen detection in clinical laboratories. It is designed to be non-inactivating so it could also potentially be used for isolating and growing viral pathogens from patient specimens. Even though DxTMTM is used with a wide array of viral pathogens, its use for clinical specimens containing SARS-CoV-2 infection has been separately characterized on numerous independent test platforms. This was performed in comparison to the Gold-Standard predicate device, where DxTM was shown to be equivalent to that Gold-Standard in terms of handling and extraction, thereby assuring the very highest standard of performance.