The Health Protection (Coronavirus) (Requirements) (Scotland) Amendment Regulations 2022 and The Health Protection (Coronavirus) (Requirements) (Scotland) Amendment (No. 2) Regulations 2022: equality impact assessment

Testing

Two main testing methods exist for detection of SARS-CoV-2: LFDs or PCR. PCR is the recommended testing method if you have COVID-19 symptoms while LFDs are recommended only for people who do not have symptoms.^[48] PCR is a highly sensitive and specific technique to detect SARS-CoV-2 and is a recommended diagnostic testing method by the World Health Organisation (the WHO)^[49]. Specificity and sensitivity levels of >95% have been reported by SAGE for PCR testing^[50].

LFD testing is effective at identifying people with the virus when they are at their most infectious and have high viral loads.^[51] A peer-reviewed study on sensitivity of the LFDs carried out by University College London found that LFDs are more than 80% effective at detecting any level of COVID-19 infection and, therefore, can be an effective tool in reducing transmission.^[52] Another study showed that LFDs are 95% effective and 89.1% specific at detecting COVID-19 when used at the onset of symptoms.^[53] A review on the diagnostic accuracy of point‐of‐care antigen and molecular‐based tests for diagnosis of SARS‐CoV‐2 infection concluded that LFDs which pass the criteria for use (e.g. WHO's priority target product profiles for COVID‐19 diagnostics) can be considered as a replacement for PCR.

Data from the Assessment of Transmission and Contagiousness of COVID-19 in Contacts (ATTACCC) study show that false negative LFD test results mostly occurred 1 to 2 days prior to peak viral load and became negative at approximately the same time as viral culture became negative^[54]. This indicates that LFDs are effective at detecting infectious cases. All the LFDs in use in the National Testing System have been shown by the British Government's Science Park, Porton Down, and University of Oxford SARS-CoV-2 lateral flow antigen test validation cell to be effective in detecting the Omicron Variant of Concern^[55].

SAGE endorsed the benefits that rapid antigen testing (such as LFD testing) could have on reducing transmission when discussing the UK Government Plan B options: "Other measures are available which, if introduced, could also make Plan B (or more stringent measures) less likely (and could potentially offer better efficiency or effectiveness) for example encouraging wider use of rapid antigen testing in workplaces and the community, and ensuring self-isolation of those who test positive by providing sufficient support".^[56]

The Scottish Government recommends to take regular lateral flow tests - especially before mixing with other people or visiting a hospital or care home, regardless of vaccine status or recent periods of infection. This will almost always identify Covid during early stages of infection and thus significantly reduce disease transmission^[57]. The optimal testing strategy in order to gain access to a high risk setting would be to take the test as close as practically possible to the time of entry. LFDs are less sensitive than PCR but have the advantage of providing rapid results, and SAGE has endorsed the benefits that rapid antigen testing (such as LFDs) could have on reducing transmission.

Customers can display an SMS (text), email or a paper printed copy showing they have registered a record of a negative test. There is no QR code within SMS or emails and so they do not need to be scanned by the NHS Scotland Covid Check App. Venues will instead perform a visual check and no data will be retained. Individuals can get an SMS or email by registering the result of their negative LFD test on the GOV.UK website, and opting in to receive notification of their result. If individuals undertake a PCR test they will automatically receive an SMS or email with the results.

The testing option requires people to have access to a standard mobile phone, mobile device or computer with an email address and access to a printer. This does not need to be a 'smart phone' and can be any mobile phone or tablet that can receive text messages or has access to email. Test results can be displayed on a mobile phone, tablet or other device, or a paper copy can be printed using a home printer or using a service which provides printing facilities, such as a public library.

For those unable to test themselves, self-test LFD kits can be administered by others (such as a family member, friend, or carer) who can also register the result on behalf of the person they tested if they are also unable to do so. For those unable to display their test results (such as people who do not have a mobile phone) when registering their result they could have it sent to another person's phone, who could then show the result on their behalf.