EKF Diagnostics’ PrimeStore MTM Successfully Evaluated by Public Health England for SARS-CoV-2 Inactivation

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. EKF’s PrimeStore MTM sample collection device allows COVID-19 samples to be rapidly inactivated in the collection tube, avoiding contamination and preserving RNA without need for refrigeration. EKF is a contract manufacturer and supplier for the PrimeStore MTM, which is an FDA-cleared and CE-marked microbial nucleic acid storage and stabilization device, owned and created by Longhorn Vaccines and Diagnostics LLC (Bethesda, MD, USA).

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 cold chain storage of samples, RNA and DNA are perfectly preserved ready for safe testing immediately on arrival at a laboratory and without need for containment. PrimeStore MTM is the only FDA Class II cleared device for microbial nucleic acid storage and stabilization (RNA and DNA) available for the safe transportation of samples which may contain viruses.

The PHE study 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 while maintaining the ability to detect the target viral RNA.