Use of lateral flow devices for asymptomatic staff testing at vaccination sites
- Overall aim
- Lateral flow device testing provision
- Summary of key points from this guidance
- Exemptions from self-isolation if a staff member is fully vaccinated and is identified as a contact of a case
- Further information
Novel coronavirus (COVID-19) standard operating procedure
Use of lateral flow devices for asymptomatic staff testing at vaccination sites
8 September 2021, Version 3
Updated in line with NHS England and Improvement’s letter setting out changes to the PHE guidance for NHS staff and students around self-isolation and return to
work following COVID-19 contact
Updates made to this document are highlighted in yellow.
Publication approval reference: C1388
This document should be read alongside the supporting frequently asked questions (FAQ) relating to your host organisation. These are:
- FAQs for primary care (organisations and staff):
- FAQs for NHS trusts (organisations and staff):
This guidance is correct at the time of publishing. However, as it is subject to updates, please use the hyperlinks to confirm that the information you are
disseminating to your staff is accurate.
Asymptomatic staff testing is an important component of the infection prevention and control (IPC), which all organisations and staff have a duty to adhere to. Continued efforts are required to keep staff and patients safe from potential transmission of COVID-19 in healthcare settings by ensuring that all staff continue to participate in this important programme.
Our aim is to provide testing to all staff working on behalf of the NHS at vaccination centre (VC) sites – including those working on a voluntary basis – using lateral flow devices (LFDs).
This standard operating procedure (SOP) is part of our work to provide an integrated testing approach and resilience in NHS staff testing for asymptomatic NHS staff using LFDs on self-swab samples, it excludes staff who are part of any other testing programme or pilot.
Regular LFD testing alongside PCR testing will improve virus detection, with the overall aim of preventing further transmission and spread.
The key objectives are to:
- protect patients
- protect staff and volunteers providing NHS services
- support VCs in their infection control risk reduction strategy
- reduce VC staff COVID-19 absence by reducing transmission between staff, and therefore improve resilience within VC settings
- support both COVID-19 and non-COVID-19 clinical pathways over future waves.
LFD tests detect the presence of the COVID-19 viral antigen from a swab sample. The test is administered by handheld devices, produces results in around 30 minutes, and can be self-administered.
Lateral flow antigen testing has a lower sensitivity than PCR. However, studies to date suggest that these tests are better at returning positive results for individuals who are infectious rather than individuals who may have had COVID-19 recently and are no longer infectious (PCR will detect both).
Lateral flow device testing provision
From July 2021 all NHS staff and vaccination site volunteers will be able order testing kits directly from www.gov.uk/order-coronavirus-rapid-lateral-flow-tests.
NHS staff and volunteers should follow the instructions and select yes to the question ‘Do you work for the NHS in England and take part in their staff testing programme?’. Staff and volunteers are encouraged to create an account when they order for the first time. This should only take a few minutes and will retain ordering information making it quicker to order future tests. Staff and volunteers can also use the same account to register results. It is possible to order and report tests without creating an account.
When staff receive their box of tests, if any of the items supplied are missing, broken, or if the device is damaged or breaks during use, if the user of the test has any concerns about the performance of the test, or if any adverse incident with the test occurs, then these incidents should be reported. Users should report this information directly to the Medicines and Healthcare products Regulatory Agency (MHRA) via their reporting portal: https://coronavirus-yellowcard.mhra.gov.uk/.
LFD technology assessment
The government has published research on LFD tests and analysis of lateral flow tests.
Summary of key points from this guidance
|PCN-led and community pharmacy-led local vaccination services||Hospital hubs and large-scale vaccination centres (VC)|
|Where do NHS staff (including temporary staff) working at VCs get LFD tests from?||LFD tests can be ordered at: www.gov.uk/order-coronavirus-rapid-lateral-flow-tests||LFD tests can be ordered at: www.gov.uk/order-coronavirus-rapid-lateral-flow-tests|
|Where do volunteers working at VCs get LFD tests from?||LFD tests can be ordered at: www.gov.uk/order-coronavirus-rapid-lateral-flow-tests||LFD tests can be ordered at: www.gov.uk/order-coronavirus-rapid-lateral-flow-tests|
|How do NHS staff (including temporary staff) working at VCs undertake testing?||Test at home twice-weekly following the NHS staff SOP||Test at home twice-weekly following the NHS staff SOP|
|How do volunteers working at VCs undertake testing?||Test at home twice weekly.||Test at home twice weekly.|
|How do NHS staff working at VCs record their results?
||On the NHS Digital self-reporting platform||On the host trust’s recording or the NHS Digital self-reporting platform according to local trust policy.|
|How do volunteers and temporary NHS staff working at VCs record their results?
||On the NHS Digital self-reporting platform||On the host trust’s recording system or the NHS Digital self-reporting platform according to local trust policy.|
Lateral flow antigen testing
All staff at vaccination sites should be provided with access to testing using LFDs. The approach to using lateral flow antigen testing in VCs is as follows:
NHS staff with existing contracts
NHS staff should carry out testing in line with their organisation and follow the guidelines in the SOP for the use of lateral flow devices for asymptomatic staff testing for SARS CoV-2 in all NHS staff (england.nhs.uk).
Positive results will need to be confirmed by PCR tests as per the arrangements for the staff member’s employing organisation.
Volunteers and temporary NHS staff
Volunteers and temporary NHS staff working at a vaccination site should order testing kits at: www.gov.uk/order-coronavirus-rapid-lateral-flow-tests.
Large scale vaccination sites may wish to hold a supply of LFDs for use by volunteers, these can be ordered via email from email@example.com.
Testing should be undertaken twice weekly by regular volunteers and on the day of a volunteer shift for ad hoc volunteers.
Volunteers and temporary NHS staff should self-administer the test in line with manufacturer’s instructions which are issued with a box of tests (this will differ slightly depending on the manufacturer).
Positive results for volunteers and temporary NHS staff, should be confirmed through PCR tests – as per the arrangements for the VC’s supporting organisation. This may need to be through www.gov.uk/get-coronavirus-test if the supporting organisation does not have access to PCR testing.
Individuals with a positive test result should immediately self-isolate and follow the national infection control guidelines. Where the confirmatory PCR is negative, the individual can return to duties unless they are displaying any symptoms of COVID-19.
A staff member who tested positive would recommence asymptomatic home testing 90 days after their PCR positive test was taken. The staff member will need to liaise with their organisation to track the date at which the retesting should start.
LFD testing is not suitable for people with symptoms of COVID-19. Symptomatic people should obtain a PCR test through www.gov.uk/get-coronavirus-test.
Exemptions from self-isolation if a staff member is fully vaccinated and is identified as a contact of a case
From 16 August 2021, fully vaccinated staff and students who are identified as a contact of a positive COVID-19 case will no longer be expected to isolate and will be expected to return to work. They should inform their line manager or employer immediately if they are required to work in the 10 days following their last contact with a COVID-19 case.
The majority of fully vaccinated health and social care staff will be able to continue in their usual role subject to the implementation of the following safeguards to enable them to safely do so:
- the staff member should not have any COVID-19 symptoms
- a negative PCR test prior to returning to their NHS workplace. Staff/students should not attend work while awaiting the PCR test result
- the staff member/student has had two doses of an approved vaccine, and is at least two weeks (14 days) post double vaccination at the point of exposure
- provision of subsequent, daily negative LFD antigen tests for a minimum of 10 days before commencing a shift (with test results reported to Test and Trace via the web portal and to their duty manager or an identified senior staff member). Any contact who has a positive LFD test should self-isolate and arrange a PCR test
- the staff member/student is and remains asymptomatic
- continued use of IPC measures, in line with the current UK IPC guidance.
If the above criteria cannot be met, or if the staff member/student has not had both doses of the vaccine, or they are living directly (same household) with a positive COVID-19 case, they will be asked not to come to work. This will remain under review. There may be times when it is appropriate for the staff/student living with a positive COVID-19 case to return to work, in line with government guidance, in a risk-assessed way, but this should be through a process agreed with an appropriate senior decision maker (eg DPH/DIPC). All staff and students must have an up to date individual risk assessment and be working in an appropriate setting for their risk status.
Reporting of results and PCR testing
It is a statutory duty that all test results must be reported, whether they are positive, negative or invalid/void. This must happen every time an LFD test is completed.
NHS staff and volunteers should use the reporting mechanism put in place by their employer and as set out in the SOP for the use of lateral flow devices for asymptomatic staff testing for SARS CoV-2 in all NHS staff (england.nhs.uk).
- The results from the device should be recorded by the staff member after the time set out on the manufacturer’s instructions. The timing is critical, as leaving the test for longer can lead to false positive results and the test will need to be repeated. Results should be recorded in line with the following:
- Negative: The presence of only the control line (C) and no test line (T) within the result window indicating a negative result.
- Positive: The presence of the test line (T) and the control line (C) within the result window, regardless of which line appears first, indicating a positive result. The presence of any test line (T), no matter how faint, indicates a positive result.
- Invalid/void result: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. When an invalid/void result is observed, the test will be repeated with a new test kit.
How to self-report an LFD test result
Staff and volunteers working in hospital hubs and large-scale VCs should familiarise themselves with and follow the host trust’s reporting policy. This may be to enter test results on the host trust’s system for recording and reporting test results or on the NHS Digital self-reporting platform. Test results should only be reported through one route to avoid double counting.
When reporting to the NHS Digital self-reporting platform, staff and volunteers will be guided through a set of questions to enable them to identify which part of the NHS they are working for; this includes options for primary care contractor groups. On clicking the link, the following steps should be followed:
- Click on the following link www.gov.uk/report-covid19-result and follow the steps below.
- Select who you are reporting the result for, either ‘myself’ or ‘someone else’.
- If you haven’t already, it is advised you create an account, you will only have to do this once and it will remember your personal details. You may also report without an account if you wish.
- Select the date you took the coronavirus test.
- Enter or scan your test ID number. You will find the ID number under the QR code on the LFD.
- Select the result of the test whether that be ‘positive’, ‘negative’ or ‘invalid/void’. Check your answers.
- Receive confirmation of registration via email.
If there are any problems with reporting an LFD test via this route, call 119. If any staff member or volunteer cannot complete the online form for reporting via this route, they can either:
- call 119 and select option 1
- ask someone else to register on their behalf (provided they have written consent to do so and can obtain personal details required to complete the form).
Test results recorded on the NHS Digital self-reporting platform are shared with Public Health England, in line with requirements to report identifiable diseases.
What staff and volunteers should do with the LFD test result?
- In the event of a negative result, the staff member or volunteer will need to record their test result in line with the supporting organisations arrangements and attend work as normal. IPC guidance must continue to be followed.If a staff member or volunteer records a negative result but begins to display symptoms of COVID-19, they should follow government guidance and obtain a PCR test through www.gov.uk/get-coronavirus-test.Similarly, if a staff member or volunteer has been advised by NHS Test and Trace or the COVID-19 app to self-isolate, they should follow the advice and continue to self-isolate, even if they get a negative LFD test result.
- In the event of a positive result, the volunteer or staff member should immediately:
- report the positive test result to their supervisor at the vaccination site (with contact tracing as per the arrangements for the host organisation)
- self-isolate, together with their household, in line with government guidelines
- record their result in line with the supporting organisation’s arrangements.
- If the test indicates an invalid result (see below) the staff member or volunteer will need to repeat the test with a new test kit.The supporting organisation should ensure staff or volunteers who are participating in LFD testing are informed on how to perform the test, how to report results and what to do if the test is positive.
This is not an exhaustive list but includes:
- Failure to follow the instructions for test procedure and interpretation of test results may adversely affect test performance and/or produce invalid results.
- A negative test result may occur if the specimen was collected or extracted from the swab incorrectly. A negative test result will not eliminate the possibility of SARS-CoV-2 infection.
- Positive test results do not rule out co-infections with other pathogens and therefore staff members may also have other respiratory infections such as Influenzae A or B.
- LFDs do not detect non-infectious virus during the later stages of viral shedding that might be detected by PCR molecular tests. Hence, they will not detect staff members who are recovering from having had the virus. Any member of staff who does test positive for the virus which is confirmed by PCR will not have to self-test for a further 90 days from the point of becoming positive.These limitations will be mitigated, as far as possible, by the actions outlined in this SOP. Some staff/volunteers will not tolerate the regular use of swabbing. Where possible, staff should be encouraged to report any difficulties they are experiencing by calling 119. Over time, the rollout of further technologies may help to mitigate this.
For queries and further information relating to LFD tests boxed in 25s, these should be directed to firstname.lastname@example.org or in writing to the NHS Testing Programme at the address below. For queries about LFD kits ordered from the GOV.UK website, please call 119.
NHS England and NHS Improvement
80 London Road