Name of partner
Project
QuantuMDx – a UK-based developer of point-of-care diagnostics, with global operations – asked the innovation lab to undertake verification studies to support CE marking for a point of care Covid-19 testing device, Q-POC.
How we helped
The Q-POC molecular testing device is quick – going from sample to result in around 30 minutes. Molecular testing for Covid-19 is the gold standard and Q-POC aims to deliver affordable testing at the point of need, rather than sending samples to a centralised laboratory.
Outcome
The innovation lab provided an independent test environment and the team performed a series of verification studies in support of CE marking for the Q-POC system. Analytical performance was measured, including looking at consistency of results in different situations.
Working closely with the technical support team at QuantuMDx, we provided around seven days of device testing and associated data.
The data generated by the innovation lab contributed to the successful verification of the Q-POC system, which then went on to obtain CE marking and market launch. We are further supporting QuantuMDx by undertaking expanded clinical evaluation studies.
In addition to this evaluation, the team also provided input for the setup of the study to ensure that the method and outcomes were robust.
Name of partner
Project
Kromek – an international company specialising in health surveillance and early pathogen detection – developed a new isothermal molecular assay for the detection of SARS-CoV-2 and required a preliminary evaluation of its accuracy.
How we helped
Our scientists at the innovation lab tested the performance of the assay, part way through its development, on positive and negative Covid samples from our biobank. Viral RNA was extracted from the samples and tested using Kromek’s assay. Samples were simultaneously tested via PCR using established methods as a comparison.
Outcome
The innovation lab team were able to show that Kromek’s assay gave accurate results when tested against real clinical samples.
The assay has been incorporated into a newly developed technology for the automated detection of COVID-19. Successful use allows sensitive and specific ‘near real-time’ detection of COVID-19 without the use of specialist equipment, reducing the cost and expanding the reach of accurate testing.
The positive results of the testing have allowed Kromek to continue with further development of the assay and incorporation into integrated testing systems.
