September 30, 2020
EKF Diagnostics, the global in-vitro diagnostics company, announces that the novel viral transport media PrimeStore® MTM (Molecular Transport Medium) has been successfully evaluated for effective SARS-CoV-2 inactivation in a new study published by Public Health England (PHE) [1]. To work safely with live SARS-CoV-2 samples requires the use of high-containment laboratories. However, after inactivation SARS-CoV-2 material can be handled at a lower containment level, allowing more laboratories to undertake testing and thereby increasing COVID-19 testing capacity.
EFK Diagnostics notes the PHE study [1] evaluated numerous commercially available reagents and laboratory formulations commonly used for viral inactivation protocols by public health agencies and research laboratories globally. All the reagents tested have been used during the current COVID-19 pandemic for sample transportation and subsequent molecular processing. A total of 23 commercial reagents designed for virus inactivation, clinical sample transportation, and nucleic acid extraction were assessed by PHE for their ability to inactivate SARS-CoV-2.
The study used TCID50 and blind passage techniques to test for any infectious virus still recoverable from all samples treated with the inactivation reagents. Notably, the study showed that PrimeStore MTM was the only commercially available transport reagent from the many tested from which no residual virus was detectable by either TCID50 or by the passaging of treated purified sample. This demonstrates the efficacy and safety of PrimeStore MTM in inactivating live SARS-CoV-2 samples whilst maintaining the ability to detect the target viral RNA.
In addition to this successful PHE evaluation of its effectiveness at deactivating SARS-CoV-2, PrimeStore MTM is also an FDA cleared and CE-IVD marked sample collection device. It is already well-proven, with millions of tubes sold globally for the inactivation and transportation of many high consequence pathogens. Therefore, this patented transport media, manufactured by EKF and confirmed by PHE to enable safe sample handling of clinical samples, can help to increase COVID-19 testing capacity.
Due to PrimeStore MTM’s advantages over generic VTM and UTM (viral and universal transport media) products, EKF has recently won a number of significant tenders with commercial partners involved in healthcare, education, and industry to supply safe sample collection kits for COVID-19 testing programs.
Amongst these commercial partners, EKF is now working with the University of Leicester for its student COVID-19 screening program, and international molecular diagnostics group, Yourgene Health, to supply kits to their customer base which includes public schools, universities and corporations. Another partner is Source BioScience which provides ISO:15189 laboratory testing services for the NHS and private healthcare.
Dr. Sean Sales, Director of Genomic Services, Yourgene Health, explained how PrimeStore MTM has helped them to streamline their workflow and reduce the turnaround time for getting COVID-19 test results out to patients. “Our primary reason for choosing the PrimeStore MTM was for safety. The MTM inactivates the SARS-CoV-2 virus whilst stabilizing the RNA. This means that we can safely handle samples we receive that could potentially contain a hazard group 3 pathogen in a Class II MSC. This in turn helps our workflow as it removes the need to inactivate the samples prior to moving to the next step.”
Sales added, “The fact that there’s no need for cold chain in the delivery process also makes delivery of samples easier and helps keep shipping costs down. We are investing in our laboratory testing facilities to enable us to run tens of thousands of samples a month, and sample stability and supply are key.”
PrimeStore MTM removes the need for all cold chain logistics including sample storage; RNA and DNA are perfectly preserved for downstream molecular processing for up to four weeks at room temperature. Furthermore, because samples are rapidly inactivated, the risk of infection is eliminated, meaning samples are ready for safe testing immediately on arrival at a laboratory and without the need for containment. In the case of COVID-19, this opens up options for more testing laboratories, making PrimeStore MTM a key part of the testing supply chain which can underpin the safe and rapid increase of testing capacity.