SARS-CoV-2 Test Kit from QuantuMDx offers High Accuracy Test Results in 70 Minutes
Coronavirus pandemic has left many regions across the world in distress and medical staff requires testing kits and other equipment to offer healthcare services to people. While medical equipment companies are trying to provide the required test kits, masks and other safety gear for medical staff and patients, UK-based QuantuMDx Group Limited announced the launch of its sensitive SARS-CoV-2 assay for laboratory use, which delivers a result in approximately 70 minutes. During the first few weeks of the pandemic, testing kits were needing a long time to confirm the results for COVID-19.
However, with time, many companies have come up with effective testing kits that can reduce the time to confirm infection results for COVID-19. The faster tests are beneficial in reducing the load on the medical system but they should also be accurate (to keep the false positives at low level).
Working with its British manufacturing partner Biofortuna Limited, QuantuMDx has scaled up production capability to initially 2M tests per week and with the potential to scale up to 3M tests per week by introducing further automation within the manufacturing process. The company management informed that QuantuMDx has rigorously stress tested its supply chains and is confident in its ability to supply significant volumes of tests worldwide.
QuantuMDx’s SARS-CoV-2 assay is a real-time reverse transcriptase rtRT-PCR test that has been developed using advanced bioinformatics to maximise performance. The assay has been designed with the most up-to-date sequence information to ensure 100% coverage of all known SARS-CoV-2 sequences. The company’s assay has been evaluated using 90 pre-extracted residual samples from The Newcastle upon Tyne Hospitals NHS Foundation Trust, UK, to assess clinical performance against tests currently in use. It has been shown to be clinically equivalent to the comparator assay presently used in NHS hospitals, with 100% concordance with all positive and negative SARS-CoV-2 classifications.
Sanjeev Krishna, Professor of Molecular Parasitology and Medicine at St George’s, University of London, said: “It’s universally acknowledged that one of the most urgent needs to help us control and hopefully eliminate the COVID-19 pandemic are good diagnostic tests. We need a test that can diagnose the disease quickly and accurately, while being available and affordable for all healthcare systems. This test is very much aiming to address those needs so we can control the infection with greater precision.”
An application has been made to the U.S FDA for use under Emergency Use Authorisation and QuantuMDx expects to attain CE-IVD mark by mid-May. In addition, QuantuMDx will apply for World Health Organization ‘Emergency Use Listing’ listing.
In silico analysis of QuantuMDx’ SARS-CoV-2 assay shows 100% specificity and 0% cross reactivity with common commensal or potentially interfering organisms. QuantuMDx is now working with St George’s, University of London to undertake CE-IVD reproducibility evaluations.
In response to the shortage of extraction kits in the current market, QuantuMDx is also validating the use of the test without the need for RNA extraction, running the RT-PCR test direct from swabs. Furthermore, the company is validating the test on other specimen types, such as saliva samples.
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