Viral Transport Media (VTM)

The Viral Transport Media (VTM) has completed the notification process under the FDA guidance “Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
For in vitro diagnostic use

Indications for Use statement
This device, Viral Transport Medium (VTM), is used for collection and maintenance of oral or nasal specimens as an aid in detection of nucleic acid from SARS-CoV-2. It is intended for use by trained clinical laboratory personnel specifically instructed on in vitro diagnostic procedures. The VTM is only for use under the Food and Drug Administration’s Emergency Use Authorization.

Device Description / Summary
The COVID-19 virus spreads primarily through small droplets produced from coughing, sneezing, and talking. Specimens need to be collected from nasal and oral cavities via swabs. These swab samples are stored and transported to the laboratory using VTM tubes.

List of Ingredients
Viral Transport Media (VTM) is designed and validated in a manner consistent with CDC's SOP, DSR-052-05, Preparation of Viral Transport Medium. Ingredients are sterile filtered 18.2 MW-cm deionized water, Hanks Balanced Salt Solution (HBSS), Gentamicin sulfate, Amphotericin B, Fetal Bovine Serum (heat inactivated) and phenol red.

Shelf Life, Stability, and Storage Instructions
Shelf life of properly stored product is one (1) year from the manufacturing date. Keep the product refrigerated at 2-10°C and do not freeze. After swab sample collection refrigerate the VTM sample tube and use blue ice containers to transport the VTM sample tubes to the laboratory. Long time storage at elevated temperatures above 20°C will result in product pH change that will be visible by color changing to purple.

Sterility Statement
VTM210 is sterile filtered, filled & capped in Class 100 HEPA enclosure.

Performance Criteria
COVID-19 virus samples were pipetted into five (5) different VTM210 tubes and five (5) different transport media tubes obtained from the Quest Laboratories. All ten (10) viral-loaded tubes were tested after two (2) and five (5) days using LumiraDX Covid RT-PCR kit and ThermoFisher Scientific QuantStudio 5 RT-PCR instrument. Additionally, VTM210 viral-loaded tubes were tested on the 8^th day using the above PCR test. VTM210 tubes shown to keep virus-load viable in all three sets of the tests. VTM210 and Quest Laboratory transport tubes have gave comparable viral replication results to give COVID-19 positive results.

Specimen stability for this media was not validated for recovery of viral infectious particles using a culture-based assay.

Manufacturer
UFC Biotechnology, Inc.
435 Creekside Drive, Suite 5
Amherst, NY 14228

Warnings & Precautions

For in vitro diagnostic use only.
The transport media has not been FDA cleared or approved.
The VTM is a transport medium that serves as a culture media, non-propagating transport.
This device is to be used by trained and qualified professionals.