QuantuMDx rapid PCR test approved by UK Health Security Agency
QuantuMDx Group’s rapid PCR SARS-CoV-2 test, with the multiplex Q-POC platform, has been approved for continued sales in the UK under the UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals) Regulations 2021 (CTDA).
The Technical Validation Group (TVG) has also published its evaluation of this 30-minute Q-POC SARS-CoV-2 assay and concluded the assay meets the acceptable criteria for sensitivity and the desirable criteria for specificity of the MHRA Target Product Profile (TPP) for Point of Care (POC) assays. The TVG analysed 135 positive and 390 negative samples and reported a specificity of 98.5% (95% CI 96.5-99.4%) and a sensitivity of 80.0% (95% CI 72.1-86.2%). It was noted within the report that there were a high proportion of patients with a CT over 30 which may affect the overall sensitivity.
Jonathan O’Halloran, chief executive, QuantuMDx, said: "We are delighted to announce that our product has been approved and added to the CTDA register and that the UK will continue to have access to our high-quality rapid PCR tests. 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."
Q-POC is a rapid, portable, sample to answer PCR device and has been designed for use in a range of settings such as hospitals, clinics, pharmacies, and workplace testing providing PCR results at the point of need. Q-POC and its first test, a SARS-CoV-2 detection assay, are CE-IVD marked under the In Vitro Diagnostics Directive (98/79/EC), enabling use within Europe. The Company also plans to expand the menu of tests for Q-POC adding a multiplex respiratory panel and sexually transmitted infections (STIs), amongst others, to the current SARS-CoV-2 assay.