COVID19

Guidance on Undertaking Routine Lateral Flow Testing for NHS Frontline Staff

Version Document author Date Changes Next Review

1.0 Hannah Bailey 19.11.2020 New SOP approved by CLOG 20/11/2020

31/12/2020

COVID19 - Guidance on Undertaking Routine Lateral Flow Testing for NHS Frontline staff

Review date: 31/12/2020 Version No: 0.2 Page 1 of 10

Table of Contents1. Background...............................................................................................................................3

2. Aim and Objectives...................................................................................................................3

3. Scope.........................................................................................................................................3

4. Out of Scope..............................................................................................................................3

5. Distribution................................................................................................................................4

6. Training......................................................................................................................................4

7. The Test.....................................................................................................................................4

8. Performing the test...................................................................................................................5

9. Test Results...............................................................................................................................9

10. Recording and Reporting the Results...................................................................................10

11. Advice and Support................................................................................................................10

12. Adverse Incidents...................................................................................................................10

13. Appendix A..............................................................................................................................10

COVID19 - Guidance on Undertaking Routine Lateral Flow Testing for NHS Frontline staff

Review date: 31/12/2020 Version No: 0.2 Page 2 of 10

1. Background

On 11th November 2020, NHS providers were informed that routine testing of all ‘patient facing’ staff was to begin in the coming weeks.

Clear rationale is provided below for taking the approach of routine testing of patient facing NHS staff:

Prevention of transmission and spread

Protection of NHS staff and patients

Improve the ability to prevent outbreaks and maintain operational service provision

At this time, routine testing will be carried out using a Lateral Flow Testing Device (LFD). Use of the lateral flow testing devices programme has been piloted in a number of early adopter Trusts, prior to wider roll out. This, together with a PCR (swab test), will provide an integrated testing approach and resilience in NHS staff testing.

The full evaluation report can be found here and detailed the following for the Innova LFD unit, currently being issued in England:

Specificity - 99.68%.

Sensitivity - 76.8% for all PCR-positive individuals, but detects over 95% of individuals with high viral loads.

Minimal difference between the ability of the test to pick up viral antigens in symptomatic and asymptomatic individuals

The use of the test is voluntary, but strongly encouraged in order to protect patients and colleagues.

2. Aim and Objectives

The aim of this guidance is to support staff to undertake routine testing, interpret results and outlines the process steps that staff will need to follow.

3. ScopeThis guidance applies to all staff defined as patient facing and only covers the use of the Lateral Flow Test Device.

For the purposes of this testing programme, lateral flow test kits are being provided for the following groups of staff:

All staff who may have direct face to face patient contact e.g. frontline clinicians and support staff that have patient facing contact e.g. housekeeping staff or estates staff.

Bank staff will be included in the initial roll out

Agency staff will not be eligible for a test in the first roll out, but once further supply is available agency staff will be able to register and collect a testing kit, we will notify these staff when we are able to proceed.

4. Out of Scope

Staff that may work for the Trust, but not deemed patient facing, will be unable to access testing at this current time. The intention of NHS Test and Trace is that a wider roll out will occur in due course.

COVID19 - Guidance on Undertaking Routine Lateral Flow Testing for NHS Frontline staff

Review date: 31/12/2020 Version No: 0.2 Page 3 of 10

In addition, this guidance only covers the use of the Lateral Flow Test Device (LFD) and will not discuss the use of other tests that may become available in time, when additional guidance will be provided.

5. Distribution

Testing kits have arrived and are being distributed to designated spaces within localities. Localities are developing solutions for staff to come and collect the testing boxes, this information will be shared by your local team and will be available on Ourspace as soon as possible.

Staff will be required to register in order to be able to collect a box. This is an essential step to ensure we have all available information, which will be submitted to Public Health England (PHE). The registration form can be found on the Covid Testing Ourspace page.

If you do not have a log in and are unable to register yourself, you will be directed to a lead administrator in your area who can register for you.

Local teams will collate a log of staff who have collected testing kits and a reminder system will be developed for staff who have collected boxes, but not submitted the results.

By signing up for the programme, you must comply with a number of steps:

Responsible use of the test, for yourself only

Using the test in line with this procedure

Recording and reporting of results in a timely manner

Returning any test boxes, if you decide that you now longer want to take part in the programme.

6. Training

Health Education England (HEE) have produced a short training video to support staff to undertake the test correctly - https://learninghub.nhs.uk/self-swab .

A staff leaflet has been developed, giving clear written instructions. Staff will receive a paper copy of this leaflet with the initial supply of the testing box. Please read this thoroughly prior to use of the test kit. The online leaflet can also be accessed via the Covid Testing Ourspace page

Additional training and support can be sought through your local testing champions, which your team leader will be able to put you in contact with. A list will be made available on the Covid Testing Ourspace page as soon as possible.

7. The Test

Lateral flow antigen testing detects the presence of the COVID-19 viral antigen from a swab sample. The test is administered by handheld device producing results in 30 minutes and can be self-administered.

Each staff member taking part will receive a box with enough supplies and 25 testing cartridges. This is enough for 12 weeks supply, when testing twice weekly.

The testing kits will arrive in boxes, containing the following:

25 foil pouches containing the test cartridge and a desiccant

two vials of 6 mls buffer solution

25 extraction tubes and 25 tube caps

25 sterilised swabs for nasal sample collection

COVID19 - Guidance on Undertaking Routine Lateral Flow Testing for NHS Frontline staff

Review date: 31/12/2020 Version No: 0.2 Page 4 of 10

Staff will need to store devices at a temperature between 4 degrees and 30 degrees, not in direct sunlight or in the fridge.

Tests must not be used:

Instead of a PCR swab test. If the lateral flow test is positive, or you have any signs or symptoms of COVID-19, a PCR swab test is still required.

To rule out COVID-19 if you have any signs or symptoms of COVID

To test other household members.

For patients.

As a reason not to fully comply with the Trusts requirements for working safely e.g. wearing a mask when indicated or to self isolate when indicated or instructed.

Staff should test themselves:

Twice a week, every three to four days.

Ideally in the morning prior to commencing work, or if shifts are worked to fit in with your shift pattern.

The test should ideally be performed in sufficient time before the next shift, to allow any absence to be reported in a timely manner e.g. in the evening before the next day shift. Taking the test just prior to the shift may lead to an increase in short notice absences, which will impact on the Trust’s ability to provide operational cover.

Whilst staff may wish to continue self-testing during periods of annual leave, there is no requirement to do so. A test should however be performed in sufficient time before the next planned shift.

If a positive result is received from a PCR swab test, lateral flow self-testing should be paused, and recommenced 90 days after the positive PCR swab test was taken. This is due to the likelihood of a false positive result sometime after the infectious period of COVID-19 has passed.

The manufacturer’s instructions for use (IFU) are included in the box and are detailed and very technical. These do not need to be followed as NHS staff will use the test in a slightly different way, which has been agreed with experts, discussed with MHRA, and the manufacturer informed. The staff leaflet you received with your test box provides the correct instructions.

8. Performing the test

A staff leaflet has been provided with the box of testing kits and staff should read this thoroughly prior to performing the test for the first time as a minimum.

This leaflet can be found here, and contains both pictorial and written instructions.

If staff are unclear support can be found through your local champions, a list of these will be made vailable on the Covid Testing Ourspace page or accessed through your management team as soon as possible.

COVID19 - Guidance on Undertaking Routine Lateral Flow Testing for NHS Frontline staff

Review date: 31/12/2020 Version No: 0.2 Page 5 of 10

COVID19 - Guidance on Undertaking Routine Lateral Flow Testing for NHS Frontline staff

Review date: 31/12/2020 Version No: 0.2 Page 6 of 10

COVID19 - Guidance on Undertaking Routine Lateral Flow Testing for NHS Frontline staff

Review date: 31/12/2020 Version No: 0.2 Page 7 of 10

Dispose of the test in normal household waste, pouring away any buffer solution first.

COVID19 - Guidance on Undertaking Routine Lateral Flow Testing for NHS Frontline staff

Review date: 31/12/2020 Version No: 0.2 Page 8 of 10

9. Test Results

Leave your test for the full development time to get an accurate result. Do not read your results until the 30 minute mark. If the test device is left to develop longer you may receive a false positive result and you will need to repeat the test. Information around interpreting your test results can be found below:

Positive

If the result is positive, you must:

Self-isolate in line with Government guidelines.

Contact your line manager who will record this on Healthroster to request a PCR swab test. You will be contacted with an appointment ideally on the same day or as soon after.

Attend the PCR test.

Await confirmation of the result

If the PCR test is negative and you remain asymptomatic, you can stop self-isolating and return to work.

If a positive result is received from a PCR swab test, lateral flow self-testing should be paused, and recommenced 90 days after the positive PCR swab test was taken. This is due to the likelihood of a false positive result sometime after the infectious period of COVID-19 has passed.Negative

If the result is negative and you have no signs or symptoms of COVID-19, no further action is required.

If the result is negative but you have any of the following signs or symptoms of COVID-19, contact your line manager, self isolate and you will be contact in the normal way for a PCR test or you can request this through the government website.

Acute respiratory distress syndrome

High temperature (of 37.8°C or higher)

New onset continuous (coughing a lot for more than an hour, or 3 or more coughing episodes in 24 hours. If you usually have a cough, it may be worse than usual).

Loss of, or change in, normal sense of taste or smell (anosmia)

Invalid

If the result is invalid, repeat the test with a new kit. The test can be repeated immediately. If the second test is invalid, please contact your line manager for further advice.

COVID19 - Guidance on Undertaking Routine Lateral Flow Testing for NHS Frontline staff

Review date: 31/12/2020 Version No: 0.2 Page 9 of 10

10. Recording and Reporting the Results

Staff must submit their results within 72 hours of completing the test, regardless of the result, or via your line manager if the result is positive. To submit results visit the Covid Testing Ourspace page

The log sheet in Appendix A may also be useful to keep your own record to help support you when submitting your results once back at work.

Whilst taking the test is voluntary, where it is conducted there is a statutory requirement to report the results.

Only staff working within the Trust’s testing team will be able to access data solely for the purposes of submitting the weekly Public Health England (PHE) return, or as part of a request for a PCR swab. The data will be kept confidential, and personal identifiable information will not be shared with line managers or any other department within the Trust.

In order to fulfil the statutory requirement, the Trust will submit data on a weekly basis to PHE, using secure transfer.

11. Advice and Support

Please phone 01225 362710 if you require any further support.

If your result is positive, or you have any signs or symptoms of COVID-19, contact your line manager to arrange for a PCR swab test.

12. Adverse Incidents

Any adverse incidents, or concerns about the accuracy of results must be reported through the normal incident reporting system.

13. Appendix A

Covid Testing Statutory Reporting Record

COVID19 - Guidance on Undertaking Routine Lateral Flow Testing for NHS Frontline staff

Review date: 31/12/2020 Version No: 0.2 Page 10 of 10