Title: QuantuMDx SARS-CoV-2 RT-PCR Detection Assay – design, analytical and multi-centre evaluation of clinical performance
White paper overview:
After completing the development of our SARS-CoV-2 RT-PCR Detection Assay, QuantuMDx undertook extensive clinical performance testing with partners. Clinical performance testing was undertaken as independent studies, carried out by a number of sites.
In all cases, the external sites chose all samples which would be tested and QuantuMDx was not privy to the results until the study was completed and analysed by each site. In a number of cases the studies were conducted to support the equivalent use of extraction methods and platforms, as well as additional real-time instruments.
Overall clinical performance was outstanding, with a positive percent agreement (PPA) or 99.4% and a negative percent agreement of 98.7%. Based upon the analytical and clinical performance data, the QuantuMDx SARS-CoV-2 RT-PCR Detection Assay provides a highly sensitive, specific and easy to use solution for centralized laboratory testing.
The assay is simple to use as the Master Mix is provided as a single reagent, containing all required components for the specific detection of three loci within the SARS-CoV-2 genomic RNA.
QuantuMDx Group is an ambitious company with a global vision of empowering the world to control and eradicate disease by making transformative, quality point-of-care diagnostic technologies universally accessible. QuantuMDx has operations and strategic partnerships in the United States, Asia, Australasia, Europe and Africa – keeping it at the forefront of molecular diagnostics.
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Debra Daglish, Marketing Communications Manager, QuantuMDx Group 0870 803 1234
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