Tuesday, July 14, 2020
EKF Diagnostics, the global in vitro diagnostics company, announces 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 programmes, 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 optimised 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 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 re-used several times. As well as reducing the risks of handling live pathogenic samples, this also cuts 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 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, 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 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 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 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 stabilisation 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 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.” 
For more information on EKF Diagnostics, see www.ekfdiagnostics.com
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
About EKF Diagnostics www.ekfdiagnostics.com or www.ekfusa.com
EKF Diagnostics Holdings plc, which includes the EKF Diagnostics, Stanbio Laboratory and DiaSpect brands, specializes in the development, production and worldwide distribution of point-of-care analyzers for use in the detection and management of diabetes and anemia, and also in sports and maternal medicine. EKF products are sold in more than 100 countries around the globe, through a network of specialist distributors.
Point-of-care diagnostics: EKF Diagnostics designs and manufactures world-class diagnostic devices, as well as distributing rapid test kits for infectious diseases and pregnancy. The EKF analyzer range is used widely in GP surgeries, pharmacies, blood banks, sports clinics, hospitals and laboratories for glucose, lactate, hemoglobin, hematocrit and HbA1c measurement.
Central laboratory: EKF, through its wholly owned subsidiary, Stanbio Laboratory (Boerne, Texas, USA), manufactures a comprehensive range of clinical chemistry reagents, as well as associated analyzers. In addition, EKF Life Sciences (Elkhart, Indiana, USA) manufactures enzymes used in reagent development and also provides contract fermentation facilities.