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Transport Media for SARS-CoV-2 Testing
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VTM-C19 Transit Tube
VTM-C19 Transit Tube
A premium transport device for use with nucleic acid testing of SARS-CoV-2 and (USA only) human influenza specimens
Biomed Diagnostics' VTM-C19 Transit Tube is intended for on-site collection and transport to the testing laboratory of human clinical specimens containing SARS-CoV-2 — the virus that causes COVID-19 disease in humans and/or (USA only) influenza A virus. 1–4
Intended to be inoculated with specimens collected with a nasopharyngeal (NP) or oropharyngeal (OP) synthetic fiber swab (not provided), VTM-C19 has been validated to transport SARS-CoV-2 and (USA only) influenza A viral specimen appropriately to the lab for analysis with qRT-PCR.
Specifications
| Product Principle | • VTM-C19 Transit Tubes ensures a non-replicating competent status of SARS-CoV-2 (COVID-19) and (USA only) influenza A. |
|---|---|
| Simple Convenience | • Safe transport and preservation of the specimen |
| Storage | The VTM-C19 Transit Tube is based on the CDC formulation which has a shelf-life of twelve-months when stored at refrigeration temperature (2-8°C) or at room temperature (18-25°C). . |
Transportation
The VTM-C19 Transit Tube is designed for safe transport. Inoculated tubes should be transported within 72 hours after inoculation and maintained at 2-8°C. 2
Regulatory
For In Vitro Diagnostic Use.
Not available in all countries; please inquire.
CE IVD marked for use with SARS-CoV-2 testing
The VTM-C19 Transit Tube is available for use in the USA under the FDA guidance “Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” (July 2020). The VTM-C19 Transit Tube has completed the Notification process. The VTM-C19 Transit Tube is available for use in the USA with FDA-cleared molecular influenza tests as described in the FDA guidance “Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” (October 2020).4
Reference
- Centers for Disease Control and Prevention (CDC) Laboratory Outreach Communication System SOP post on 3-21-20: cdc.gov/coronavirus/2019-ncov/downloads/Viral-Transport-Medium.pdf
- FDA authorized instructions for use. fda.gov/media/134922/download
- Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-viral-transport-media-during-coronavirus-disease-2019-covid-19-public-health
- Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-modifications-fda-cleared-molecular-influenza-and-rsv-tests-during-coronavirus
- CDC preventing transmission of infectious agents in healthcare settings guidelines; cdc.gov/infectioncontrol/guidelines/isolation