EKF supports COVID-19 testing with novel sample collection device

EKF is a contract manufacturer and supplier for the PrimeStore MTM, which is an FDA-cleared and CE-marked microbial nucleic acid storage and stabilisation device, owned and created by Longhorn Vaccines and Diagnostics LLC (Bethesda, Maryland). PrimeStore MTM deactivates viruses, bacteria, fungi and mycobacterium tuberculosis, allowing safe sample handling and transport, and eliminating the risk of infection during transport and in laboratories. In addition to removing the need for expensive cold chain storage of samples, RNA and DNA are also perfectly preserved by PrimeStore MTM for up to four weeks, ready for safe testing immediately on arrival at a laboratory and without need for containment. This opens up capacity for more testing laboratories. Longhorn first introduced this unique device in 2006 in preparation for a worldwide pandemic and it has already been used in testing for many infectious diseases and high consequence pathogens, including influenza, RSV, TB, HIV and coronavirus. COVID-19 has led to a significant increase in global demand for PrimeStore MTM, which is the only FDA Class II cleared device for microbial nucleic acid storage and stabilisation (RNA and DNA) available for the safe transportation of samples which may contain viruses. In addition to more than doubling its current manufacturing capacity in the US on behalf of Longhorn, EKF has now rapidly repurposed its European manufacturing facilities in Cardiff and intends to introduce manufacturing at its sites in Germany. The establishment of the UK-based production line has increased staffing levels at EKF’s Cardiff facility with 12 temporary contracts. These positions have been filled by local workers recently out of work due to the impact of the pandemic or on leave from their studies. The site is expected to produce up to 12,500 sample collection tubes daily. This substantial increase in manufacturing capacity is to meet not only new US orders, but also new European supply contracts for PrimeStore MTM; including an agreement with Source BioScience UK Ltd which provides ISO:15189 laboratory testing services for the NHS and private healthcare. It is working with a number of businesses to provide COVID-19 testing services for their staff to enable them to bring back those who may be self-isolating due to concerns over

To support the increase in COVID-19 testing globally, a safe and easy sample collection and transport mechanism is essential. EKF Diagnostics, the global in vitro diagnostics company headquartered in Cardiff, has secured new contracts for the manufacture and supply of a novel, patented sample collection device, PrimeStore MTM. This allows COVID-19 samples to be rapidly inactivated in the collection tube, avoiding contamination and preserving RNA without need for refrigeration.

infection, or that of a family member.

“We are delighted to supply Longhorn’s PrimeStore MTM collection kits to Source BioScience, a well-established provider of testing services to the NHS. These collection kits will ensure that COVID-19 samples can be handled and transported without expensive refrigeration or fear of contamination. This is a key part of the testing supply chain which can underpin the safe and rapid increase of testing capacity. In addition to the US, we will continue to ramp up our production capacity here in the UK and in Europe to meet increasing demand and support efforts to limit the spread of coronavirus globally.” Julian Baines CEO, EKF Diagnostics

“We are very encouraged with this partnership and significant development from EKF, which allows the removal of cold chain transportation, making logistics of samples less expensive and more available to the many hospitals and businesses needing to regularly test key workers and staff. This dramatically expands the reach of COVID-19 testing services to a larger population and will support a faster economic recovery.” Jay LeCoque Chairman and CEO Source BioScience

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