Following the Covid-19 crisis and the consequent surge in the demand of Covid test kits, the UK Medicine & Healthcare products Regulatory Agency (MHRA) has published several Target Product Profiles concerning IVD Devices for COVID-19 diagnostics.
Target Product Profiles outline the required specifications for a particular type of device, by establishing its intended purpose, target users and technical characteristics in order to assist manufacturers in producing devices in accordance with the present clinical needs.
Through the Target Product Profile published on the March 3, 2021, the MHRA laid down the required specifications and performances for rapid breath tests for the direct and indirect detection of SARS-CoV-2. This type of devices should offer a rapid and easy-to-use means for identifying positive cases in the context of large scale events, or in scenarios where tests are frequently repeated (e.g. workplaces or schools).
In the document, the MHRA identifies both the ideal and the minimum characteristics devices should meet to be aligned with the UK testing strategy. In particular, the devices should be intended for use by lay persons for the direct or indirect detection of SARS-CoV-2 infection within symptomatic and asymptomatic people of all ages in non-healthcare settings. The specimen should be a gaseous, aerosol or liquid phase breath sample, analyzed within the device ideally.
With regards to the performances, the MHRA requires:
- Ideal sensitivity of 97% (in any case, no less than 70%);
- Ideal specificity greater than 99.9% (99% being the minimum acceptable) and;
- Invalid test rate below 0.1% (maximum acceptable, 1%).
The total time required to complete one test should not exceed 40 seconds (even though up to 2 minutes could still be considered acceptable) with the result being delivered within 15 seconds (maximum 90 seconds), in an easy-to-understand way (ideally a binary positive or negative output).
For software, compliance with standard BS EN 62304:2006+A1:2015 is mandatory. Additionally, the possibility to connect the devices to the NHS LIMS systems, or to an alternative track and trace system, is considered as highly desirable. In this case, the device must also comply with standards DCB0129 and DCB0160.
Finally, IVD Devices – including the ones concerned by the proposed Target Product Profile – need to be compliant with the UK or EU medical device legislation (UKCA mark, CE UKNI or CE mark), except in the cases provided for by Regulation 12 of the UK Medical Device Regulations 2002.
Manufacturers interested in marketing rapid breath tests for Covid-19 in the UK can consult the full list of requirements set by the MHRA accessing the TPP.
Regulatory Affairs Department
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- Medicine & Healthcare products Regulatory Agency (2021). Target Product Profile: Rapid Breath Tests for the direct and indirect detection of SARS-CoV-2. Retrieved on the 18/06/2021 from https://www.gov.uk/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work