Pathogenic sample collection and transportation kit launched
EKF Diagnostics has launched a PrimeStore MTM sample collection kit. This new kit facilitates convenient and safe collection, transportation and handling of pathogenic samples, including SARS-CoV-2 and influenza.
Two kit configurations are now available: a postal sample kit ideal for home use, and a multi-pack of sample kits suitable for on-site mass sampling. To meet growing demand for this sample collection device, EKF has increased its manufacturing capacity in the UK and mainland Europe.
Pathogenic samples stored in the FDA-cleared, CE-IVD marked PrimeStore MTM novel viral transport medium, including SARS-CoV-2, are inactivated within minutes of collection. This allows such samples to be transported safely through the postal system or via courier, and complies with UN3373 packaging regulations. Furthermore, as samples are stable in PrimeStore MTM for seven days at ambient temperatures, this removes the need for all cold chain logistics during sample collection, transportation and storage, thereby preventing mishandled samples and making postal collection a realistic option.
Multiple nucleic acid species can be tested from one sample as RNA and DNA are perfectly preserved and stabilised by PrimeStore MTM for downstream molecular applications. Furthermore, because PrimeStore MTM totally inactivates SARS-CoV-2, as demonstrated by a recent Public Health England evaluation study, the risk of infection to laboratory staff from samples is eliminated. This means that samples are not only safe during transportation, but also ready for immediate safe testing at a laboratory, with no need for containment.
The new sample collection kit pairs PrimeStore molecular transport medium in a cryovial with a sterile flocked swab (for nasal and oral sampling) in a CE-marked kit, which also includes a UN3373 95 kPa-compliant specimen collection bag, absorbent pad and instructions for use. In addition, the postal sample collection kit includes a UN3373-compliant postal box with security seal for sample return and postal pouch for collection kit delivery.
To ensure that it can fulfil the increasing orders for PrimeStore MTM and the new sample collection kit, EKF is ramping up manufacture in the UK and also mainland Europe. The company has now started production at its facilities in Barleben, Germany, and will soon be moving its current Penarth-based manufacturing lines in Wales to a new larger facility in Llandough, Cardiff.