QuantuMDx Group announced that its rapid PCR SARS-CoV-2 test, used with the multiplex Q-POC platform, has been approved for marketing in the UK.

The regulatory approval was granted pursuant to the UK Health Security Agency (UKHSA)’s Coronavirus Test Device Approvals (CTDA) regulations 2021.

UKHSA, formerly Public Health England (PHE), works closely with the Medicines and Healthcare Regulatory Agency (MHRA), NHS England, and other government agencies.

Q-POC SARS-CoV-2 assay has been designed as a rapid, simple to use, portable, sample to answer PCR device that delivers accurate PCR results within 30 minutes.

The assay can be used in a wide range of settings, such as hospitals, clinics, pharmacies, and workplace testing, said QuantuMDx.

Q-POC and its SARS-CoV-2 detection assay have received the CE-IVD mark approval under the In Vitro Diagnostics Directive, and can be used in Europe.

Beyond the SARS-CoV-2 testing, the company is planning to add a multiplex respiratory panel and sexually transmitted infections (STIs) test to Q-POC, to expand its scope.

QuantuMDx chief executive Jonathan O’Halloran 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.”

The Technical Validation Group (TVG) has evaluated the Q-POC SARS-CoV-2 assay.

TVG concluded that the assay meets the criteria for sensitivity and the desirable criteria for specificity of the MHRA Target Product Profile (TPP) for Point of Care (POC) assays.

In the TVG analysis of 135 positive and 390 negative samples, the assay demonstrated a specificity of 98.5% and a sensitivity of 80%.

Furthermore, QuantuMDx is planning to roll out a range of syndromic multiplex testing assays in the future.