Boxed set of 25 SARS-CoV-2 antigen rapid qualitative tests, lot X2103013, date of manufacture 2021.03.08, expiry date 2023.03.07, containing instruction leaflet, qualification certificate, 2 cardboard buffer tube holders, 25 sealed SARS-CoV-2 Antigen test Cartridges, 25 sealed disposable swabs, 25 plastic buffer solution holders, and 2 6 ml bottles of extraction solution, made for Innova Medical Group, Inc by Xiamen Biotime Biotechnology Co., Ltd, China, 2020-2021

Rapid lateral flow tests involve rubbing a long cotton swab over the tonsils and inside the nose or inside the nose only. The swab is mixed with a buffer solution and added to a device similar to a pregnancy test. The test kit has an absorbent pad at one end and a reading window at the other. Inside the device is a strip of test paper that changes colour in the presence of COVID-19 proteins (antigens). Results are given in 30 minutes. The UK government recommend their use for people with no symptoms of COVID-19 and to use them twice a week.

Innova Medical Group provided kits for the first mass testing programme in the UK, in Liverpool in November 2020. All people living and working in the city without symptoms of COVID-19Testing by Public Health England and the University of Oxford showed that Innova’s tests were found to have an average sensitivity (the proportion of people with a disease that have a positive test) of 57.5% and an average specificity (a measure of how good the test is at detecting true negative cases) of 99.6%. During the Liverpool pilot, between 6 November 2020 and 30 April 2021, 283,338 (57%) Liverpool residents took a test using the Innova test. Those who tested positive for COVID-19, received a PCR (polymerase chain reaction test) to confirm the findings. In general, there was an increase in identifying people with COVID-19 but without symptoms. Cases in Liverpool were reduced up to mid-December. However, after that a new variant of COVID-19 made it difficult to understand what was happening. Some scientists and researchers had concerns about the accuracy of the tests. In July 2021, three UK studies confirmed the use of lateral flow tests and found that accuracy remained high regardless of who performed the test.