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Article History

Received: 31 May 2024

Accepted: 23 December 2024

First Online: 13 January 2025

Declarations

:

: Within the context of the pandemic public health response and roll-out of testing interventions, after review using the UK Health Research Authority (HRA) tool () and further discussions with HRA, it was determined that these evaluations (described in this report) did not require HRA ethics approval. After an initial period, it was determined to gain Public Health England’s Research Ethics and Governance Group (PHE REGG) approval (then separate to NHSTT) for service evaluations for subsequent studies to ensure further external scrutiny and assurance on this approach. Approval was obtained for an umbrella framework (UKHSA framework for evaluating the safety and effectiveness of devices and new testing methods for diagnosing COVID-19 and other infectious diseases (ISRCTN-ISRCTN50943319)) and associated participant-facing materials for the prospective data collection elements of Service Evaluation and Ongoing Evaluation. This was reviewed and approved under IRAS project ID: 317913 and REC reference-22/SC/0340. All study participants received routine care through receipt of an individual diagnostic swab test and result. Participants gave verbal documented consent to participate in the evaluation. The service evaluations conformed to the ethical principles of the Declaration of Helsinki.

: Not applicable.

: David Chapman is an employee of Deloitte MCS Ltd. All remaining authors declare no competing interests.