QuantuMDx Group has obtained approval for its rapid PCR SARS-CoV-2 test, with the multiplex Q-POC platform, under the Medical Devices Coronavirus Test Device Approvals (Amendment) Regulations 2021 (CTDA) of the UK Health Security Agency.
The Q-POC SARS-CoV-2 assay uses three targets, the ORF1, N and S genes, to deliver rapid PCR results in 30 minutes on the portable Q-POC Platform.
This simple to use platform has been designed for use in an extensive range of settings, including pharmacies, hospitals, clinics and workplaces, to provide accurate PCR results at the point of need.
The platform and its SARS-CoV-2 detection assay are now CE-IVD marked under the In Vitro Diagnostics Directive (98/79/EC).
Furthermore, the Technical Validation Group (TVG) has published the Q-POC SARS-CoV-2 assay’s evaluation results.
The findings demonstrated that the assay meets the criteria for specificity and sensitivity of the MHRA Target Product Profile (TPP) for point of care (POC) assays.
After assessing 390 negative and 135 positive samples, the TVG reported a 98.5% specificity and 80% sensitivity for the assay.
QuantuMDx CEO Jonathan O’Halloran said: “Our assay design strategy, to include three targets, where most only target one or two regions of the SARS-CoV-2 genome, is continuing to prove to be robust and we are confident that our tests and device remain able to detect all known variants, as is the case with the recent Omicron variant, by which none of our test’s three targets have been affected.”
Additionally, the company plans to expand the test menu for Q-POC, adding sexually transmitted infections (STIs) and a multiplex respiratory panel to the existing SARS-CoV-2 assay.