NEWCASTLE UPON TYNE, UK, 22 December 2020. QuantuMDx today confirms its diagnostic assay for SARS-CoV-2 remains suitable for detecting all available virus strains, following the identification of a new variant of SARS-CoV-2.
The UK COVID Genomics Consortium and Public Health England have identified a new strain of SARS-CoV-2 which is characterised by multiple spike gene variants. The new strain known as VUI-202012/01 or lineage B.1.1.7 appears to be significantly more transmissible than other circulating linages and there are reports that some diagnostic tests may be affected.
QuantuMDx continually monitors genomic sequences deposited to the NCBI and GISAID databases as part of post market surveillance. Analysis of VUI-202012/01 genomes shows that none of the variants interfere with QuantuMDx’ three target SARS-CoV-2 test.
QuantuMDx’ high performance SARS-CoV-2 RT-PCR Detection assay has been proven against seven separate sample cohorts including independent evaluations from FIND, several hospitals and UK DHSC. Aggregated across cohorts, totalling over 800 samples, clinical sensitivity was shown to be 98.9% and specificity 99.8%.
Jonathan O’Halloran, Chief Executive, QuantuMDx, said:
“At the start of the outbreak, we anticipated the emergence of new strains as the pandemic progressed and designed our assay to target three different genomic regions of SARS-CoV-2. We can confirm that this new strain of virus will not affect our assay which maintains its high level of sensitivity in the UK and worldwide. We continue to work with regional, national, and international health authorities as we continue efforts to deliver high quality diagnostics for COVID-19.
“Q-POC™, our 30 minute, swab to result PCR point-of-care device, is nearing launch and will run an assay targeting the same three loci as the QuantuMDx SARS-CoV-2 RT-PCR Detection Assay. We are already experiencing great demand for this incredibly powerful device and want to assure our customers that our test will work across all strains represented in the online SARS-CoV-2 genome databases.”
Debra Daglish, Marketing Communications Manager, QuantuMDx Group Limited
Chris Gardner, Matthew Neal and Lindsey Neville, Consilium Strategic Communications – moc.smmoc-muilisnoc@xdmutnauq
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