Classification: Official
Publications approval reference: C1096

Lateral flow antigen test FAQs for independent sector providers

Version 2, 29 April 2021

Following communication with independent sector providers on 21 April 2021, the process for accessing lateral flow testing kits has now changed.

From 29 April 2021, all orders should be directed to NHS Test and Trace.

This standard operating procedure is only relevant to lateral flow testing kits (containing 25 individual tests), ordered from NHS England and NHS Improvement before this date.

There is new guidance for all testing kits ordered from NHS Test and Trace.

Frequently asked questions

These FAQs specifically relate to the lateral flow antigen tests for patient-facing staff providing NHS services in the independent sector.

Q1. What type of test are we rolling out?

The Innova SARS-CoV-2 Antigen Rapid Qualitative Test uses a swab which has been in contact with the nostril of the person being tested. The swab is inserted into the extraction tube with the extraction fluid and then rotated and pressed to make sure that the sample from the swab is released into the extraction fluid (swab is then discarded at this point).

You then take the extraction tube with the nozzle cap and place two drops of extraction fluid into the sample well of the LFD testing device cartridge and wait 30 minutes for the result on the test device.

Q2. What is the specificity and sensitivity of this particular test?

Government has published its latest research on these tests.

Q3. Is the test mandatory or voluntary?

Tests are voluntary, but staff should be strongly encouraged to take part to help keep their workplace safe for patients, visitors and all their colleagues.

Q4. How should we report test results and why do we need to report negative results?

You should report ALL results from your lateral flow tests, including negative results. You must report all test results using this simple and quick tool.

COVID19 is a notifiable disease, and therefore the legislation sets out the requirement that all results (negative, positive, or invalid / void) are reported. This helps our understanding of the progression of the pandemic, and of the efficacy of the tests themselves, and ensures that your important contribution to our national effort is counted.

The only exception to this is where large independent sector providers (ISPs) are using the Public Health England (PHE) POCT portal. In this case, providers should continue submitting data in this form as directed by PHE.

Q5. Which staff members in the organisation will have access to lateral flow antigen tests?

All asymptomatic patient-facing staff delivering NHS services in England should be offered lateral flow antigen testing. This should include temporary patient-facing staff who may provide NHS services through a contractor or are employed through an agency or other kind of temporary arrangement.

Q6. How frequently should staff be tested?

Staff should test themselves twice weekly every three to four days to fit with shift patterns and leave requirements: eg Wednesday and Sunday, or Monday and Thursday.

Q7. What happens if staff get a positive result?

Staff should inform their manager of a positive result in the normal way and a confirmatory PCR test will be arranged. Staff and their household should isolate as set out in government guidance.

Q8. What happens if my test is negative, but I have coronavirus symptoms?

If you have coronavirus (COVID-19) symptoms, please refer to NHS guidance.

Q9. How will potentially positive staff receive a confirmatory PCR test?

Providers should use their normal processes to access tests for staff members who have symptoms of COVID-19, whether that be through pillar 1 or 2. These processes assume that staff may be infected with COVID-19 and therefore suitable infection prevention and control (IPC) and personal protective equipment (PPE) will be in place. Staff should continue to isolate until they have the results of the PCR test.

Q10. Is confirmatory PCR testing accessible through pillar 2, and if yes what field should be filled to avoid symptomatic questions?

You should use whatever PCR route is in use by your organisation. If this is through pillar 2, tick the box that indicates you are a key worker but not part of a pilot, you will then see an option to say ‘I’ve been told to take a coronavirus test’ on the form.

Q11. What should staff do with the used tests?

Staff can safely dispose of the test items in their normal household waste but should first pour any residual buffer solution away.

Q12. What happens if the buffer solution is accidentally consumed?

As set out in the manufacturer’s safety instructions, the buffer solution is not hazardous; however, if accidentally ingested, you should inform a medical practitioner.

Q13. What is the shelf-life of the extraction (buffer) solution once opened?

The shelf life of extraction solution is two years, even after it is opened.

Q14. How do I get more bottles of extraction (buffer) solution as I don’t have any left (due to spillage, etc) but I still have kits left in my box of 25?

Extraction fluid can only be supplied in multiples of 100 bottles, these can be requested from the NHS England and NHS Improvement national team. Should your organisation require fewer than 100 hundred bottles, it should request replacement test kits from the NHS England and NHS Improvement national team.

Q15. At what stage is Test and Trace informed of the result?

At the point the confirmatory PCR test result is known, and this is positive, test results will, as normal, be referred to Test and Trace.

Q16. If a staff member has a positive PCR COVID-19 test, when should they start the lateral flow antigen tests again?

A staff member who tested positive would recommence home testing 90 days after their positive test was taken. The staff member will need to liaise with their organisation to track the date at which the retesting should start.

Q17. Are two positive lateral flow antigen test results considered to be an outbreak?

Lateral flow antigen positive test results should be confirmed with PCR testing. If the confirmatory test is also positive, then normal outbreak protocols apply.

Q18. How many tests will staff get?

The testing kits will arrive in boxes containing the following:

• 25 foil pouches containing the test cartridge and a desiccant
• two vials of 6 mL buffer solution
• 25 extraction tubes and 25 tube caps
• 25 sterilised swabs for sample collection
• The manufacturer’s instructions for use of the device (IFU). NB: You should not follow these. You will receive instructions for NHS staff separately from the box, and it is these that you should follow.

Q19. Should I continue to test after I’ve received the COVID-19 vaccine?

Yes.

Q20. What action does ISPs take regarding reporting test results?

ISPs take no action in report results as individual staff members are responsible for reporting their results to PHE, in line with statutory requirements for COVID-19 reporting. ISPs should encourage their staff to test twice weekly and to report their results.

Q21. Can lateral flow tests be used for patients?

No. PCR tests should continue to be used for patients.

Q22. Should patients who have been directly cared for by a staff member who tests positive with lateral flow be tested while the confirmatory PCR test result is pending?

Your organisation’s protocols for tracing contacts should be followed.

Q23. Does lateral flow testing replace and regular testing regimens that staff are already following, such as participation in COVID-19 studies?

If staff are already enrolled in another testing regimen, lateral flow tests should not replace this unless agreed by your organisation.

If staff are participating in research studies where the frequency of testing is not weekly (eg monthly), they should still undertake twice-weekly LFD self-testing.

Q24. Will this testing regimen remove the need for staff who have been exposed to a positive COVID-19 case to self-isolate?

Government self-isolation advice should be followed at all times. This test does not remove the need to self-isolate.

Q25. Are any staff groups being prioritised in the roll out of self-testing?

Sufficient volumes of the lateral flow devices will be sent to organisations to enable all asymptomatic patient-facing staff delivering NHS services to self-test.

Q26. Can staff use the tests for their symptomatic family members?

No. Family members who have symptoms should access tests in the normal way.

Q27. Can tests be used as a response to COVID-19 outbreaks?

No. Should an outbreak be declared in your organisation, it will discuss testing regimens in line with its normal organisational response.

Q28. Why is the testing method different from that described in the manufacturer’s instructions for use?

To enable easier self-administration of the test and based on advice from experts, we are recommending a swab is used and the sample nasally taken in a different way from that described in the manufacturer’s instructions: more rotation of the swab at a lower level of penetration. The manufacturer has been informed of how asymptomatic staff will use the test in the NHS, and organisations have been asked to provide a local support package for their staff (a helpline/further training and, if deemed necessary, on-site training arrangements). We recommend that staff are observed by a trained healthcare colleague the first time they administer the test.

Q29. You say that it is recommended that the first test is observed. This presents logistical issues, so can I be trained to take the test but not observed?

We advise that any staff member who needs support to take the test is given appropriate support and training and observed on the first occasion. Providers should use their discretion as to which staff may require additional support. Observation of the first test is not mandatory for all staff.

Q30. Is there advice on giving staff time back from undertaking the test at home?

The test should take no longer than 5 minutes to undertake, with a 30-minute wait for results.

Q31. Should staff continue swabbing during annual leave?

Staff may continue to swab while on annual leave of longer than a week, but it is not a requirement.

Q32. Is the lateral flow guidance leaflet in other languages?

There are no plans to translate the lateral flow guidance leaflet.

Q33. When deliveries arrive, what size of space should be allocated for them

Depending on the volume an organisation requires for its staff, tests may be delivered on pallets. There are 12 boxes on a pallet, and each contains 27 smaller boxes for distribution to staff with 25 tests in each – 8,100 tests in total.

Q34. Should the tests be kept in specific conditions? Do they require security like Tamiflu did?

Tests can be stored in typical warehouse conditions; they do not need refrigeration but should be kept out of direct sunlight and not be exposed to heat. They are not expected to require any additional security than other NHS deliveries.

Q35. How do ISPs order test kits?

To order lateral flow tests, independent sector providers should contact their commissioner, who should raise through their regional testing lead. Queries can also be directed to the NHSE National Team.

Q36. Can organisations procure their own supply of lateral flow tests?

Lateral flow tests for staff delivering NHS services are purchased and provided centrally, so should not purchase directly from suppliers.

Q37. For organisations with multiple sites, can they have tests delivered to multiple sites?

Due to the logistics required, we can only have a single delivery for each organisation. Organisations will be notified in advance of the delivery schedule.

Q38. What about staff in local authority teams, eg school nurses, or those in care homes or hospices?

The Department of Health and Social Care (DHSC) is responsible for rolling out lateral flow antigen tests to local authorities and staff delivering care outside the NHS. Contact LFDincidents@dhsc.gov.uk for more information.

Q39. How can I get tests for my staff who aren’t delivering NHS services?

DHSC is responsible for rolling out lateral flow antigen tests to staff delivering care outside the NHS. Contact LFDincidents@dhsc.gov.uk for more information.

Q40. Where should I direct any enquiries?

Email questions to england.covid-LFD@nhs.net.