Portable PCR System Compresses Entire Molecular Diagnostic Laboratory into Single Device for COVID-19 Testing at POC

QuantuMDx Group Limited (Newcastle upon Tyne, UK) has launched Q-POC - a rapid, PCR point of care diagnostic system - and its first test, a SARS-CoV-2 detection assay, which are now CE-IVD marked under the In Vitro Diagnostics Directive (98/79/EC), enabling use within Europe. Q-POC has been designed for front-line healthcare professionals and can be used within a wide range of settings, including emergency rooms, ICU, birthing centers, clinics, and pharmacies.

The Q-POC SARS-CoV-2 assay is contained within a sealed, single use test cassette designed for safety, ease of use and to eliminate contamination risk. On-board reagents are also lyophilized for room temperature storage, convenient shipping and a longer shelf life. QuantuMDx’s Q-POC SARS-CoV-2 Assay has been designed with the most up-to-data sequence information to ensure 100% coverage of all known SARS-CoV-2 sequences. The Q-POC SARS-CoV-2 assay has been evaluated to assess clinical performance against tests in current use. The Development & Assessment of Rapid Technology (DART) Study shows 96.9% sensitivity (at CTs <35), 98.3% specificity and 0% cross reactivity with common commensal or potentially interfering organisms.

“Q-POC represents a new class of molecular diagnostic device: it’s fast, battery operated, can multiplex and is so simple to operate that anyone can be trained to use it. It’s a true point of care diagnostic system,” said Jonathan O’Halloran, Chief Executive, QuantuMDx. “Our Q-POC system is future-proof, and packs a great deal of complexity and power behind its modern lines and simple operation. Our SARS-CoV-2 test is just the first in a portfolio designed to meet real clinical needs. Over the next few years, we’ll be driving menu expansion, comprising large syndromic panels and antimicrobial resistance mutation panels, ensuring we remain at the forefront of molecular, point of care diagnostics globally.”

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QuantuMDx Group Limited