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.

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 TCID50or 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.

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 stabilising 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 is 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 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.

Commenting on the results of the PHE evaluation study, Rebekah Stibbs, Product Manager for PrimeStore MTM at EKF Diagnostics said, “We were very pleased to note that the PHE study concluded that not all inactivation media are equal. The PHE study showed that infectious SARS-CoV-2 virus remained recoverable in treated samples after inactivation with most reagents tested. PrimeStore MTM was the only commercially available CE-marked and FDA cleared media that had no residual virus detected.”

Stibbs added, “The PHE study, and the fact that PrimeStore MTM is proven technology used since 2006 for the inactivation and transportation of many high consequence pathogens, have given our commercial partners the confidence to now employ it in their COVID-19 testing programmes. As we enter the start of a second phase of the COVID-19 pandemic, the need for safe, low cost, low maintenance sample transportation is needed more than ever before. This is so that the four UK governments can reach their testing targets and the UK as a whole can start to transition back to a normal way of life as soon as possible.

Reference:

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).

About EKF Diagnostics

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.

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