QuantuMDx’ SARS-CoV-2 test validated for use by NHS Test & Trace
3rd February 2021 | QuantuMDx Team
- Conclusions verify QuantuMDx’ previous analyses of test performance
- Results confirm this is one of the most sensitive tests on the market
- Fulfils the requirements of the MHRA’s Target Product Profile for Lab-Based SARS-CoV-2 Viral Detection tests
NEWCASTLE UPON TYNE, UK, 3rd February 2021. QuantuMDx today announces its sensitive SARS-CoV-2 assay for laboratory use has been validated by NHS Test and Trace.
Key conclusions from the report verify QuantuMDx’s performance claims, confirming that the test has a Limit of Detection of less than 500 copies/ml, clinical sensitivity of 98.9% and clinical specificity of 99.1%, making it one of the most sensitive tests on the market. Furthermore, its performance fulfils the requirements of the MHRA’s Target Product Profile (TPP) for Laboratory-Based SARS-CoV-2 Viral Detection tests, essential for NHS Test & Trace’s validation process.
QuantuMDx’ SARS-CoV-2 assay, which delivers a result in approximately 70 minutes, following preparation and extraction of RNA is a real-time reverse transcriptase PCR (rtRT-PCR) test that has been developed using advanced bioinformatics to maximise performance. The assay has been designed with the most up-to-date sequence information available to ensure 100% coverage of all known SARS-CoV-2 sequences. This involves in silico analysis against The GISAID database at least fortnightly, or whenever new variants of concern are identified. The sensitive test targets three unique SARS-CoV-2 specific genomic loci; the S and N genes and the Orf1ab region. The assay can run on multiple open real-time PCR platforms, both high and low throughput. Furthermore, the assay reagents are lyophilised in a single vial, eliminating multiple pipetting steps, enabling convenient shipping and longer shelf-life.
Jonathan O’Halloran, Co-founder and Chief Executive Officer of QuantuMDx said: “We are pleased to see the publication of this report which confirms our test to be a sensitive and specific laboratory assay and underlines the quality of our science and development process. The progress that has been made with diagnostics, testing, and the emergence of an approved vaccine this year, is incredible. Despite this, however, we must not rest and must continue to fight this pandemic.”
QuantuMDx is also independently validating the use of the test without the need for RNA extraction, running the RT-PCR test directly from swabs. Furthermore, the company is validating the test for use with additional specimen types, including saliva.
In addition to having developed a SARS-CoV-2 test for laboratories, QuantuMDx continues preparations for scale- up and manufacture of its Q-POC™ rapid point-of-care testing device which would allow the sensitivity of molecular testing to move beyond the laboratory. The company is currently translating its SARS-CoV-2 detection assay to the Q-POC™ platform, as a respiratory panel for the detection and differentiation of SARS-SoV-2, Influenza A & B. Using swab samples, a Q-POC™ test could provide a result in approximately 30 minutes, at the point-of-need.
Debra Daglish, Marketing Communications Manager, QuantuMDx Group Limited
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