VTM-C19 Transit Tube

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Transport Media for SARS-CoV-2 Testing

VTM-C19 Transit TubeVTM-C19 Transit Tube

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VTM-C19 Transit Tube

 

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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
 

FAQ

Technical Questions
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).
Currently we are shipping VTM-C19 as a cold product
Biomed can provide the Validation report on an as-requested basis.
Internal validation (qRT-PCR) were conducted using Roche Light cycler, and the RNA was extracted using QIAGEN RNA extraction kit
Biomed’s VTM-C-19 has been validated to maintain the viral specimen at Room Temperature for up to 72 hours, after inoculation.
Current shelf life of the product is 5 months from the date of manufacture, in refrigerated storage conditions of 2-8°C. The product may be stored at Room Temperature for up to one month.

Room Temperature validation is ongoing and will be update monthly. .
Biomed does not manufacture swabs; but we do supply NP or OP swabs. See iClean Swabs for more information.
Product Qty Item #
VTM-C19 Transit Tube 50 11-602-002

Reference

  1. 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
  2. FDA authorized instructions for use. fda.gov/media/134922/download
  3. 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
  4. 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
  5. CDC preventing transmission of infectious agents in healthcare settings guidelines; cdc.gov/infectioncontrol/guidelines/isolation