EKF Diagnostics, a global in vitro diagnostics company, has announced that it has added a novel viral transport media for the safe sample handling and testing of multiple infectious diseases from a single swab to its product range. PrimeStore® MTM (Molecular Transport Medium) is an FDA cleared and CE IVD marked sample collection device which deactivates viruses, including COVID-19, flu A, flu B, HIV and TB. Already proven in the U.S. market, this fully patented device ensures transportation and workplace safety for disease testing programs, greatly reducing risk of infection to health workers, couriers, and lab technicians.
Traditional viral transport media (VTM) were designed for transporting live samples to be cultured and also contain ingredients that inhibit optimal molecular testing. However, modern molecular tests do not require viable virus, but just intact microbial nucleic acids. Molecular testing is now widespread due to its improved performance and turnaround times compared to traditional microbiology testing. In fact, most currently approved tests for COVID-19 and other infectious diseases are nucleic acid-based molecular assays, so removing the need for and risk of live pathogen transportation for routine testing.
Designed and optimized for molecular testing, PrimeStore MTM is a unique FDA class 2 cleared sample collection and transportation device that effectively kills viral and bacterial pathogens whilst preserving and stabilizing the released DNA and RNA. The molecular transport media supports many downstream molecular applications, including qPCR and next-generation sequencing. The sample can be safely stored at ambient temperature for up to 7 days and re-used several times. As well as reducing the risks of handling live pathogenic samples, this also helps to cut costs by eliminating cold chain requirement and need for Category 3 facilities, as testing can take place outside of containment.
As multiple tests can be processed from one sample swab, this makes it ideal for the approaching flu season since samples stored in PrimeStore MTM can be tested for both COVID-19 and influenza from a single sample that has been inactivated and stabilized. This can assist with disease differentiation at reduced costs.
“PrimeStore MTM is a real game-changer for the sampling and transport of pathogenic samples from a safety, reliability and cost perspective,” said Julian Baines, CEO, EKF Diagnostics. “It’s clear that we need a strong testing program ready for flu season and a potential second wave of COVID-19 – as thousands of people are going to start presenting with symptoms that could be flu or coronavirus. We have a sample collection kit that was designed in 2006 specifically for pandemics, it’s FDA cleared and CE IVD marked, and can be used to collect both flu and COVID-19 samples in one kit. The kit immediately neutralizes infectious samples and doesn’t require refrigerated transport so it’s safer, cheaper and easier to use than standard collection kits.”
PrimeStore MTM is proven technology with millions of tubes already sold globally during and prior to the COVID-19 pandemic to hospitals and laboratories who trust that it provides safer and more reliable testing than traditional VTM or universal transport media, saline, or RUO devices. Multiple peer-reviewed scientific papers have been published from 2011 onwards, validating the use of PrimeStore MTM for reliable pathogen detection from a wide variety of clinical matrices and biofluid types, and with a range of analytical platforms. A selection of these references are available on the EKF website.
Recently, a consortium of researchers put forward the case for biosafety in pathogen transportation and testing through the adoption of virus-inactivating VTM which kill biological pathogens whilst ensuring DNA and RNA stabilization and preservation for molecular applications. They noted that PrimeStore MTM has been extensively analyzed to effectively inactivate/kill viral, bacterial and fungal pathogens while preserving the stability of the released DNA and RNA for diagnosis, and is FDA cleared. They also observed that, “Moving to virus-inactivating VTM at collection allows risk mitigation from transportation and handling of bio-specimens for diagnosis and can potentially reduce the need for special packaging and transportation measures for SARS-CoV-2/COVID-19 test samples.”
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