09 July 2021 | News
96.9% sensitivity, 98.3% specificity
Photo Credit: QuantuMDx
QuantuMDx Group Limited, a UK-based developer of transformational point-of-care diagnostics, announces the launch of Q-POC™ - a rapid, PCR point-of-care diagnostic system.
Launching at ECCMID 2021, QuantuMDx’s Q-POC™ system and its first test, a SARS-CoV-2 detection assay, are now CE-IVD marked under the In Vitro Diagnostics Directive (98/79/EC), enabling use within Europe.
The Q-POC™ SARS-CoV-2 assay has been evaluated at St George’s, University of London, 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™ is a portable PCR system that compresses an entire molecular diagnostic laboratory into a simple to use, accessible, and affordable single device offering rapid, molecular diagnostic testing at the point of care, with results in approximately 30 minutes. 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 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.
Jonathan O’Halloran, Chief Executive, QuantuMDx, said: “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. 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.”
Jonathan O’Halloran added: “Working with our British manufacturing partner, Cogent Technology and Singapore-based, Univac, we have scaled manufacturing to ensure security of supply for our customers and we are excited to be open for business.”
QuantuMDx was awarded £16m UK government funding in March 2020 to develop the company’s portable diagnostic testing system, Q-POC™, and disposable cassettes to allow for rapid, point-of-care testing for the SARS-CoV-2 virus in high and low-resource settings. The funding also included £3.2m towards production of QuantuMDx’ lab-based coronavirus test which is now commercially available.