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VTM-C19 TRANSIT TUBE

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.
•    Suppresses the growth of other bacteria and fungi that may be present in clinical samples from the human respiratory system

Simple Convenience

•    Safe transport and preservation of the specimen
•    Compatible with approved nucleic acid extraction and qRT-PCR tests

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
 

Technical Questions

 WHAT TYPE OF MEDIA IS USED IN VTM-C19 PRODUCT?

The VTM-C19 Transit Tube contains a viral transport medium (VTM) intended to be inoculated with nasopharyngeal (NP) or oropharyngeal (OP) synthetic fiber swab specimens for transport to the lab.

VTM-C19 transport media is designed for specimen preservation in preparation for analysis with validated qRT-PCR assays to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes COVID-19 disease in humans.

This is CDC-approved media for COVID-19 sample collection and transport. VTM-C19 has been validated for stable transport of SARS-CoV-2 only.

Biomed Diagnostics also offers Saline .85% transport media for a general viral transport – our R&D lab has validated the Saline .85% for SARS-CoV-2, and the Saline is checked throughout the shelf life of the product for sterility by our QC Labs

 

The VTM-C19 was validated by our internal R&D team using qRT-PCR (N1 gene). Validation results confirmed that VTM C19 maintained the viability of the RNA for 72 hours post sample collection (when stored at 2-8°C. Cell lysate of SARS-Cov-2 infected cells were used for validation (not live virus).

 

BROCHURE

 

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