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Teknova, Hollister, Calif, has completed the process of FDA notification for its Active Viral Transport Medium (ATM). ATM is a room temperature-stable version of Teknova’s CDC formulation Viral Transport Medium (VTM) and is manufactured under GMP conditions in compliance with ISO 13485 standards.
The requirement for refrigerated storage and transport of nasopharyngeal samples for viral testing poses significant logistical and financial challenges that have increased dramatically with mass covid-19 testing. Teknova CEO Stephen Gunstream says Teknova’s proven track record of rapid product development and expertise in media formulation make the company ideally suited to face these challenges head-on.
“After the successful rollout of our VTM, we were looking for new ways in which Teknova could help in the fight against covid-19,” says Gunstream. “We realized that developing a transport medium that eliminates the need for refrigeration of samples during storage and transport would allow healthcare systems worldwide greater access to covid-19 testing.”
After sample collection, ATM maintains viral stability at room temperature for up to 72 hours and can also be stored at room temperature prior to use. ATM is tested for pH (USP <791>), conductivity (USP <644>) and sterility, and additional quality control is applied in the form of bioburden testing (USP <61>). Using bovine serum albumin for ATM instead of fetal bovine serum (FBS) provides better lot-to-lot consistency and eliminates the risk of RNA degradation by Teknova Completes FDA Notification for Room Temperature-Stable Viral Transport MediumRNases present in FBS, giving users and clinicians greater confidence in their test results.
For more information, visit Teknova