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.
Update as of June 9, 2022: after consulting with the US FDA and conducting real-time validation and stability tests, the shelf life of VTM part numbers UM01-0001 and UM01-0003 have been extended from 12 months to 21 months effective immediately.
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.
The bulk VTM is tested for sterility per CDC protocol, before being filled into sterile, 15ml, 10.5 cm long tubes to accommodate break points on a variety of swabs. Item UM01-0003 is filled with 3 mL of VTM, and item UM01-0001 is filled with 1 mL of VTM.
Other Information & FAQ’s
- Both item numbers are packed 50 tubes/box.
- 50 tubes is the minimum order quantity and unit of measure (1 each = 50 tubes)
- 1 case contains 20 boxes, meaning each case contains 1,000 tubes
- Both items were manufactured exclusively for RMBIO by our sister company WelGENE in South Korea.
- WelGENE is included on the FDA’s VTM notification list which can be viewed by clicking this link
- VTM is intended to sustain the viability of viruses/other organisms and therefore does not contain substances like guanidinium/guanidine thiocyanate or similar that inactivate viruses.