EKF introduces novel molecular transport media for dual COVID-19 and influenza sampling

EKF Diagnostics, the global in vitro diagnostics company, has added a novel viral transport media for safely handling and testing 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 that 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, significantly reducing the risk of infection to health workers, couriers, and lab technicians.

Traditional viral transport media (VTM) were designed to transport live samples to be cultured and contain ingredients that inhibit optimal molecular testing. However, modern molecular tests do not require viable viruses but just intact microbial nucleic acids. Molecular testing is now widespread due to its improved performance and turnaround times compared to traditional microbiology testing. Most currently approved tests for COVID-19 and other infectious diseases are nucleic acid-based molecular assays, removing the need for and risk of live pathogen transportation for routine testing.

Designed and optimised for molecular testing, PrimeStore® MTM is a unique FDA class 2 cleared sample collection and transportation device that kills viral and bacterial pathogens while preserving and stabilising 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 reused several times. In addition to reducing the risks of handling live pathogenic samples, this also cuts costs by eliminating cold chain requirements and the need for Category 3 facilities, as testing can occur outside containment.

Multiple tests can be processed from one sample swab, making it ideal for the approaching flu season. Samples stored in PrimeStore® MTM can be tested for COVID-19 and influenza from a single sample that has been inactivated and stabilised. 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 of EKF Diagnostics. “It’s clear that we need a strong testing programme ready for flu season and a potential second wave of COVID-19, as thousands of people will start presenting with symptoms that could be flu or coronavirus. We have a sample collection kit designed in 2006 specifically for pandemics; It’s FDA-cleared and CE-IVD-marked and can be used to collect flu and COVID-19 samples in one kit. The kit immediately neutralises infectious samples and doesn’t require refrigerated transport, so it’s safer, cheaper, and easier to use than standard collection kits.”

PrimeStore® MTM is a proven technology. Millions of tubes were sold globally during and before the COVID-19 pandemic to hospitals and laboratories that 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 various clinical matrices and biofluid types and with various analytical platforms. A selection of these references is available on the EKF website.

Recently, a consortium of researchers put forward the case for biosafety in pathogen transportation and testing by adopting virus-inactivating VTM, which kills biological pathogens whilst ensuring DNA and RNA stabilization and preservation for molecular applications. They noted that PrimeStore® MTM has been extensively analysed 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.” [1].

References:

• [1] Rajan Dewar, David Baunoch, Kirk Wojno, Vinita Parkash, and Roya Khosravi-Far (2020). VIRAL TRANSPORTATION IN COVID-19 PANDEMIC: INACTIVATED VIRUS TRANSPORTATION SHOULD BE IMPLEMENTED FOR SAFE TRANSPORTATION AND HANDLING AT DIAGNOSTICS LABORATORIES. Archives of Pathology & Laboratory Medicine. In-Press. Early Online Release – https://doi.org/10.5858/arpa.2020-0175-LE