2nd October 2020 Product update: EKF Diagnostics Holdings plc
Transport Media Demonstrates its Safety by Total Inactivation of SARS-CoV-2
EKF Diagnostics, has announced 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, it 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.
The PHE study1 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 programmes.
Amongst these commercial partners, EKF is now working with the University of Leicester for its student COVID-19 screening programme, 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.
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 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.
For more information on EKF Diagnostics, see www.ekfdiagnostics.com.
1. Stephen R. Welch et al. (2020). Inactivation analysis of SARS-CoV-2 by specimen transport media, nucleic acid extraction reagents, detergents and fixatives. J. Clin. Microbiol. (In Press).
Date Published: 2nd October 2020
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