The government has published Target Product Profiles (TPP) which set out how these tests work, the standards they should meet, and in what settings they should be used.
Test kits in the UK are regulated by the MHRA, which is responsible for administering and enforcing the law on medical devices in the UK. It has a range of investigatory and enforcement powers to ensure their safety and quality.
As with all medical devices sold in the UK, manufacturers must place a CE mark on products that diagnose diseases (sometimes known as IVDs).
Tests without a CE mark are not legally allowed to be placed on the EU and UK markets unless they have an exemption. All tests granted an exemption during the pandemic are published by the MHRA.
Employers must make sure that the test kit they or their provider is procuring is legal in the UK either through having the CE mark or an exemption.
A virus test will identify whether somebody has COVID-19 at that moment.
<> If a member of staff tests positive, the member of staff will be informed by the laboratory analysing the test and should:
- immediately self-isolate (or continue to self-isolate if they are already doing so) for ten days from the point of developing symptoms, if they have symptoms, or ten days from the date of the test if they do not.
- share information promptly about their recent contacts when they are contacted by the NHS Test and Trace service so that Test and Trace can alert those contacts if they need to self-isolate.
<> If they test negative for the virus, this means they are at low risk of having COVID-19 at that moment in time. It does not mean they are definitely negative for COVID-19 nor that they are no longer at risk of catching it in future. A member of staff does not need to self-isolate if their test is negative, as long as:
<> no other member of their household has symptoms or has tested positive
<> no one in their support bubble has symptoms or has tested positive
<> the NHS Test and Trace has not told them to self-isolate
<> they feel well – if they feel unwell, they should stay at home until they feel better.
See more details on what a virus test result means.
<> If testing symptomatic staff, a virus test should be carried out as soon as possible and, in all events, within the first five days of having symptoms. Employers can also refer symptomatic staff for NHS virus testing through the Employer Referral Portal.
The NHS Test and Trace service is for those who display symptoms of COVID-19 or who have been advised to take a test by a medical practitioner or public service. Employer and third-party healthcare providers must not advise individuals without symptoms to get a test from the limited supply offered by Test and Trace, but may offer alternative private provision, in accordance with this guidance
<> If testing asymptomatic staff, the current advice is clear that a virus test will tell the individual whether they potentially have COVID-19 at that moment in time. If employers wish to offer repeat tests to asymptomatic staff, there is not yet a clinically-defined number of times that an individual should be tested within a given timeframe.
<> If somebody subsequently develops symptoms after receiving a negative results after being tested when not displaying symptoms, they must self-isolate and be re-tested.
An employer or third-party healthcare provider is strongly encouraged to make sure the systems below are in place, as a minimum, before procuring its services:
- clear governance and lines of accountability e.g. Senior Responsible Officer, Clinical Lead, Quality Lead, Training Lead
- staff are appropriately trained and there is evidence of competency assessment and participation in the External Quality Assessment (EQA) competency tool
- liability and indemnity cover for staff
- a verification report for the laboratory element of the test (known as the assay), in line with national protocols
- appropriate laboratory information management systems (LIMS) to monitor sample delivery and tracking
- working to containment level CL3 or CL2+ with HSE approval
Laboratories are legally obliged to ensure they have a mechanism to report any positive COVID-19 cases to PHE as a notifiable disease.
Clinical responsibility to report positive virus test results
When collecting results, all medical practitioners have a statutory duty to report positive results of COVID-19 virus tests under the Public Health (Control of Disease) Act 1984 and the Health Protection (Notification) Regulations 2010.
<> If a member of staff has a positive virus test result, employers and third-party healthcare providers should ensure that the laboratory processing the tests are meeting their legal requirement to notify PHE, and are advised that the laboratory is aware of how to do this by following PHE's guidance for diagnostic laboratories reporting notifiable diseases.
An antibody test looks for the presence of antibodies (produced by people with the virus to counteract it) against the COVID-19 virus.
<> If they receive a positive result indicates the person has previously had the virus but does not indicate immunity to COVID-19 infection. Those who test positive should continue to follow safer workplace guidelines including social distancing measures.
<> If they receive a negative result, they too should continue to follow these safer workplace guidelines.
It is important to recognise that there is currently no strong evidence to suggest that those who have antibodies have developed long-lasting immunity which would prevent them from getting the virus again.
The value of antibody tests is currently limited to answering the question of whether someone has had the virus or not and helping us to understand more about the virus and how it spreads.
Third-party healthcare providers and any staff responsible for procuring test kits on behalf of the employer are strongly advised to be aware of the MHRA's guidance below:
The packaging and labelling must also clearly advise on the correct storing, handling and transporting of the device.
Everyone who is responsible for overseeing sample collection must understand these instructions clearly and are encouraged to feed information into manufacturers' post market surveillance system through the Coronavirus Yellow Card Reporting Site. MHRA has published guidance on reporting to the yellow card scheme for health care professionals.