This product consists of storage tube and Viral Transport Medium (VTM) designed specifically for SARS-CoV-2 (also known as coronavirus and Covid-19) testing, according to the United States Centers for Disease Control (CDC) protocol #DSR-052-05. Based on Hank’s balanced salt solution, the medium has a stable pH and osmotic pressure, which provides an appropriate transport and storage environment for the specimen. In addition, the presence of appropriate protein components from US origin Fetal Bovine Serum helps maintains sample stabilization, and Gentamicin (an antibiotic) and Amphotericin (an antifungal) are included to minimize contamination of bacteria and fungi during transportation to maintain virus samples under prescribed conditions for routine nucleic acid extraction, genetic testing, PCR testing, etc. This product has not been reviewed by the FDA.

RMBIO VTM was tested and successfully validated via the Cepheid Xpert Xpress SARS-CoV-2 test, an automated in vitro diagnostic test for qualitative detection of nucleic acid from SARS-CoV-2, performed on GeneXpert Instrument Systems. The Xpert Xpress SARS-CoV-2 test is only for use under the Food and Drug Administration’s Emergency Use Authorization.

Shelf Life & Expiration

After consulting with the US FDA and conducting real-time validation and stability tests, in accordance with our quality system, RMBIO has determined the shelf life of RMBIO VTM is up to 24 months from the date of manufacture.

Storage/Stability

The liquid medium can be stored ambient until expired. Deterioration of the liquid medium may be recognized by (1) precipitate or particulate matter throughout the solution, (2) cloudy appearance, (3) color change, and/or (4) pH change. The nature of supplements added may affect storage conditions and shelf life of the medium. Product label bears expiration date. Specimen stability for this media was not validated for recovery of viral infectious particles using a culture-based assay.

RMBIO conducted an accelerated temperature study and showed our VTM can be stored ambient (2-25°C). The CDC recommends inoculated samples be stored at 2-8°C for up to 72 hours. If a testing delay longer than 72 hours is expected, the CDC recommends freezing the sample.

VTM-BSL-03M vs UM01-0003

RMBIO VTM part number VTM-BSL-03M replaces part number UM01-0003. The products are identical except for the manufacturing locations and appearance of the 50-piece boxes. Additional information is available below:

• Part number UM01-0003 was manufactured exclusively for RMBIO by our sister company Welgene Inc. located in South Korea.
• Part number UM01-0003 utilizes a plain white box with a single label sealing the lid to the rest of the box.
• Part number VTM-BSL-03M was manufactured by RMBIO in the United States.
• VTM-BSL-03M utilizes a pre-printed white box. Multiple labels are affixed to the boxes providing updated information like the extended shelf-life, that was not available when the boxes were produced.
• Both products were validated at Community Medical Center in Missoula, Montana via the Cepheid GeneXpert Instrument Systems platform.
• Both products are included on the FDA VTM notification list which can be viewed here: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-viral-transport-media-during-covid-19