There have been many clinical studies carried out on SIGMA-MM™ over the years to prove that it not only inactivates infectious pathogens in 60 seconds, but also preserves the DNA and RNA for safe transportation of samples for at least 21 days at room and refrigerated temperatures.
Why choose SIGMA-MM™?
The COVID-19 pandemic has highlighted the need for a safe and stable specimen collection and transportation medium that is regulated and reliable.
There is a range of unregulated and untested products on the market, that state they do the same, with little supporting evidence to back up these claims.
SIGMA-MM™ has been on the market for many years and has consistently proven to inactivate infectious microorganisms from specimens, including mycobacteria, bacteria, and viruses.
Where is SIGMA-MM™ used?
SIGMA-MM™ is being successfully used around the world by various healthcare organisations, World Health Organisation, Public, Private, Independent labs, and governments worldwide.
What recent studies have been done on the SIGMA-MM™?
Luton and Dunstable Hospital NHS Trust
A study carried out by Luton and Dunstable, has proven that not only does SIGMA-MM™ inactivate infectious pathogens like SARS-CoV-2, but also preserves the RNA at room temperature and refrigerated temperatures for at least 21 days. The RNA is stable to use for molecular diagnostic and the medium can be tested through many molecular platforms.
The addition of SIGMA-MM™ has revolutionised their laboratory processes plus they have also incorporated this inactivation media into their POCT where Rapid analysis is being carried out near the patient without the need for sending the specimen to a laboratory. This has proven invaluable within their A&E departments.
In this study, SIGMA-MM™ was tested within their laboratory on a variety of kits. These included CerTest ViaSure SARS-CoV-2 Kit, the Roche Liat using a SARS-CoV-2 Kit and the GeneXpert to detect RNA for SARS-CoV-2, and it worked reliably and safely.
Medical Research Council & University of Glasgow’s Centre
Studies carried out in Glasgow proved that SIGMA-MM™ inactivates infectious SARS-CoV-2 pathogen in 60 seconds.
As per requirement of BS EN 14476, there should be a titre reduction of more than 4 log10 for virucidal suspension tests. SIGMA-MM™ consistently exceeded this requirement for both the time points and concentrations used in the study.
Validation is important!
Throughout the pandemic there have been many unregulated products with claims that cannot be proven. MWE’s products are not only backed-up with clinical data but are also regulated and validated to meet international standards, such as the CLSI-M40-A2.
It is important to understand that the specimen collection device (swab) and the transport medium are both equally important to generate good quality viable results. If the swab doesn’t function well and isn’t good quality, the results will be inaccurate & unreliable. Similarly, if the medium cannot stably store the specimen and has contaminants that affect results, the results may be incorrect.