Everyone entering England from abroad must take one or more international travel tests for coronavirus (COVID-19).
Depending on their vaccination status, people who’ve entered England from abroad need to take an international travel test either:
- on or before day 2 only
- on or before day 2 and on or after day 8
There are different rules for people who’ve been in a country on the red list during the 10 days before they arrive.
By law, all tests privately provided for international arrivals must meet and maintain the minimum standards from 12 November 2021. The standards for day 2 lateral flow tests are outlined below.
There is separate guidance on the minimum standards providers must meet for day 2 and day 8 PCR testing.
People arriving from abroad who have a legal duty to quarantine for 10 days may be able to opt into Test to Release for international travel to shorten their quarantine period. Providers for Test to Release must meet separate minimum standards.
Find a coronavirus (COVID-19) travel test provider if you’re arriving in England
You can compare and choose a test provider based on cost and whether they are available in your region.
The government does not endorse or recommend any specific test provider – you should do your own research about them and their terms and conditions.
Click here to use the UK Government’s test provider service.
Self-declaration
Providers must also complete a declaration that their tests meet all of these standards. This will be made available the week commencing 25 October 2021. As well as declaring that they meet the minimum standards at the start of the service, they must maintain these standards from 12 November 2021, and implement and maintain any revisions to the standards, within a reasonable time period.
This self-declaration must only be completed by front-end providers who will be directly selling day 2 lateral flow tests for mandatory coronavirus (COVID-19) testing for international arrivals who are eligible to follow the rules for fully vaccinated individuals.
The providers completing the self-declaration will self-declare on behalf of themselves and all of the organisations they’re working with to provide these tests. They will need to list all organisations that they will be working with (whether by subcontract or otherwise) in order to carry out this service.
If there is a change to any information submitted in their self-declaration, the provider will need to notify the Department of Health and Social Care (DHSC) of the nature of the new arrangement.
Penalties and offences
If a private provider does not meet the standards required, they may be committing an offence and subject to enforcement action and the resultant penalty.
Problems with test kits and results
Where a test kit is broken, is not delivered or gives an inconclusive or invalid test result, the provider should offer a replacement kit as soon as possible to the consumer.
Minimum standards that apply to day 2 lateral flow tests
In this guidance, when we talk about ‘eligible’ arrivals, we mean those who are eligible to follow the rules for people who have been fully vaccinated under an approved vaccination programme.
1. Requirement for a medical director and clinical scientist
The provider of the test must have a designated resourced role that has oversight and approval of medical practices undertaken by the provider and responsibility for reporting medical issues. The individual must be a registered medical practitioner, registered with the General Medical Council.
The provider must also have a designated resourced role that has oversight of clinical practices undertaken by the provider and responsibility for reporting clinical issues. The individual must be a registered clinical scientist, registered with the Health and Care Professions Council. The same individual may fulfil both roles (medical and clinical), providing they are duly registered.
2. Requirement for effective system of clinical governance
The provider of the test must have an effective system of clinical governance in place, which includes appropriate standard operating procedures in relation to the carrying out of the tests being provided for mandatory day 2 lateral flow testing for eligible international arrivals.
For example:
- clear governance and lines of accountability such as senior responsible officer, clinical lead, quality lead, training lead
- staff are appropriately trained and there is evidence of competency assessment and participation in relevant external quality assessment (EQA)
- liability and indemnity cover for staff
- information management systems to monitor sample delivery and tracking
- systems to meet the provisions for handling, transportation and analysis of test samples
- systems, processes and record management to support the delivery of safe and reliable service
3. The test device must be an approved lateral flow device which is permitted to be put into service in accordance with part 4 of the Medical Devices Regulations 2002, other than solely by virtue of regulation 39(2) of those regulations
This requirement is to ensure that the testing device has a CE marking (or, following the UK’s exit from the European Union, a UK marking) and does not benefit from a derogation from those standards.
A CE mark is a logo that is placed on an in vitro diagnostic (IVD) medical device to show that it conforms to the requirements of the In Vitro Diagnostic Medical Devices Directive 98/79/EC.
A CE mark shows that the testing device is fit for its intended purpose stated and meets legislative requirements relating to safety. Tests with a CE mark can be used until 30 June 2023.
Alternatively a test with a UKCA mark can be used.
The word ‘approved’ relates to a process by which coronavirus test devices must be approved by the Secretary of State at the time that it is provided/dispatched to the international arrival. This is under regulation 34A of the Medical Devices Regulations, which was inserted into Part 4 by the Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021.
4. Alignment to DHSC MHRA target product profile scope and the test must be supplied in accordance with the manufacturer’s Instructions for Use
The Medicines and Healthcare products Regulatory Agency (MHRA) has published target product profiles (TPPs) for different types of test, setting out the ‘scope’ of what that test should be used for, including target use, target user and target use settings.
The provider must declare that they’re using the test in line with its published scope. MHRA has set out guidance explaining how both virus and antibody tests work.
The manufacturer’s Instruction for Use (IFU) set out the target use, target user and target setting and seek to ensure that, for example, the tests which are being sent for self-administration at home are the right sort of tests for that purpose.
The manufacturer must demonstrate that they hold evidence to support the intended use as stated in their IFU. For example, if the self-test may be used by a lay person to help another lay person take the test, they must have evidence to support this use scenario. The IFU should make this clear and there should also be evidence of performance data to support their use in these situations.
5. The test must use either nasal swabbing (mid turbinate or anterior nares) and/or tonsillar swabbing or saliva, in accordance with the manufacturer’s IFU
Where the international arrival self-administers the lateral flow test, the international arrival will be required to send their evidence of the test result for provider verification within 15 minutes of the read time of the test. These measures increase the overall reliability and user acceptance of the lateral flow test.
6. Each test device must be uniquely identifiable
The provider must ensure that each test device that is sold is uniquely identifiable, and the provider must have a system in place to reject results from previously used devices.
7. The test result must be verified by the provider with, as a minimum, a single photographic evidence when the provider does not witness the test service (self-administered tests taken over video call still require photographic evidence)
The provider is responsible for analysing and verifying the result and reporting it to the UK Health Security Agency (UKHSA). The test result must be verified by the provider with, as a minimum, a single photographic evidence, when the test is self-administered meeting the following criteria:
- the lateral flow test device must be identifiable as the test provider’s
- the photograph must also show the international arrival’s unique test booking reference
- the result must be clearly visible
8. Reporting of coronavirus test results, as a notifiable disease
The provider must have a system in place for reporting positive, negative and inconclusive international travel test results cases in accordance with their obligations under public health legislation. All results of tests for this purpose must be reported within 24 hours of them receiving evidence of the test result.
At booking, the provider (or subcontractor, if relevant) must have a system in place to collect the following data fields from international arrivals:
In relation to the person being tested:
- first name
- surname
- sex
- date of birth
- NHS number
- ethnicity
- home address (including postcode)
- the address provided to the test provider as the place where the international arrival is able to receive a confirmatory test
- telephone number (only in the case of SARS-CoV-2 positive or indeterminate results)
- email address (only in the case of SARS-CoV-2 positive or indeterminate results)
- whether or not the individual has received a vaccine against SARS-CoV-2
Together with data required to be reported under public health legislation, the provider (or their subcontractor, if relevant) will need to have a system in place to collect from the international arrival and report the following additional data fields:
- their coach number, flight number or vessel name (as appropriate)
- the date on which they last departed from or transited through a country or territory outside the common travel area
- the country or territory they were travelling from when they arrived in the UK, and any country or territory they transited through as part of that journey
- test booking reference
- the date of their arrival in the UK
- confirmation that the test complies, and was undertaken in accordance, with the requirements applicable under the International Travel and Operator Liability Regulations
- confirmation that the test is a lateral flow device test undertaken by an eligible traveller
- where the test provider did not administer sample collection services (that is, take the swab), the date and time that the test provider received evidence of the test result
In relation to the test:
- name of the test provider and a description of its operations
- test result code (such as COVID-19 +ve/-ve or influenza A +ve/-ve)
- specimen identification number
- specimen type
- specimen date
- date the test was performed
- test method (lateral flow test)
- name of the testing equipment manufacturer
9. Reporting international travel test sales
Each day the provider must complete a daily report that details total sales to travellers arriving into England on the day of report completion, including the number of tests they sold on that day.
The report must also include the following details in relation to each test sold on that day:
- the date of the arrival in England of the person in respect of whom the test was sold
- the type of test used (lateral flow test)
- whether the purchase of the test has been cancelled
- the test reference number given to the person who bought the test
Test sales should be reported by the traveller’s date of arrival in England. Providers must report whether tests sold are for eligible or non-eligible arrivals from countries not on the red list. Test providers must also provide the test booking references for the sale completed on that day.
This will need to be filled in by each customer-facing provider that is selling tests directly to international arrivals.
These reports must be submitted daily through a live form provided to testing providers who meet minimum standards.
This information will not be used for any commercial purposes.
10. Relevant systems in place to report adverse test incidents
The provider must be able to demonstrate that it has systems in place to identify any adverse incidents or quality control issues in respect of the test device and be able to report them in a timely manner to the relevant regulatory body. MHRA has a dedicated COVID-19 yellow card portal to report adverse incidents with medicines, medical devices and diagnostics.
11. Reference number format
At the time the test is booked, the test provider must provide a single test reference number to the person booking the test. If the provider sells multiple tests to one person, each test will require its own booking reference.
The booking reference must be in the required format which the provider must provide to UKHSA at the point of on-boarding.
12. Issuance of booking reference
Providers must only issue a booking reference to a customer once payment has been taken.
13. Subcontractors or organisations you are working with
If the test provider arranges with another provider or person (for example, a subcontractor) to carry out any element of the single end-to-end testing service on their behalf, the test provider must ensure that such person complies with the necessary requirements as relevant to the carrying out of that element of the service. This must result in the full end-to-end process meeting all the relevant minimum standards.
14. Notification of international travel test result: providers must issue the result of tests in a set notification which tells the person arriving from abroad whether they are required to quarantine
Form A: negative lateral flow international travel test result
Your coronavirus (COVID-19) test result is negative. You did not have the virus when the test was done.
You are not required to self-isolate.
You should self-isolate again if you get symptoms of coronavirus (COVID-19) – get an NHS coronavirus (COVID-19) test from www.gov.uk/get-coronavirus-test and self-isolate until you get the results.
For advice on when you might need to self-isolate and what to do, go to www.nhs.uk/conditions/coronavirus-covid-19 and read ‘Self-isolation and treating symptoms’.
Form B – positive lateral flow international travel test result
Your coronavirus test result is positive. This means that you probably have the virus.
Even if you have not had symptoms of coronavirus you must now self-isolate for 10 days from the day after your test date.
You must obtain, take and return a free follow up polymerase chain reaction (PCR) test from NHS Test and Trace to confirm this. You can obtain your confirmatory PCR test by visiting gov.uk/get-coronavirus-test or by calling 119.
This test will be free of charge and will be sent to you as a home test kit.
You must take this test in accordance with this notice. If this confirmatory test is negative, you no longer need to self-isolate.
You may be contacted for contact tracing and to check that you, and those who you live or are travelling with, are self-isolating.
You must not travel, including to leave the UK, during self-isolation.
Contact 111 if you need medical help. In an emergency dial 999.
Form C: unclear lateral flow test result
Your coronavirus test result is unclear. It is not possible to say if you had the virus when the test was done.
You must self-isolate for 10 days from the day after your test date.
You may choose to take another test, and if it comes back with a negative result, you no longer need to self-isolate. You may be contacted to check that you are self-isolating.
15. Confirm the address for the confirmatory PCR
When a person arriving from abroad gets a positive lateral flow test result, the provider must confirm with the traveller the address to which a confirmatory PCR must be sent, and report that address to UKHSA.
16. Compliant with all legal and regulatory requirements, for sample collection, processing and sharing of results including the requirements of data protection legislation
The Information Commissioner’s Office (ICO) has set out frequently asked questions (‘FAQs’) on data collection and data protection relating to coronavirus (COVID-19) that provide further information, including GDPR (general data protection regulation) considerations:
It is for you to satisfy yourself, taking legal advice as necessary, that you have met all the relevant legal and regulatory requirements relating to data protection. However, you will want to take full account of the fact that the processing of an international arrival’s health data is subject to additional levels of protection by Article 9 of the GDPR and can only be disclosed where it is necessary and proportionate for one of the specific purposes set out in that Article.
You are also reminded that you run a risk of breaching Article 5 of the GDPR and the Data Protection Act 2018 and being subject to significant regulatory penalties if, having obtained health data from an international arrival under these standards, you:
- retain that data for longer than is necessary in order to fulfil your role as a test provider operating in accordance with these standards
- process that data for a purpose that would be incompatible with the purpose for which the data was initially collected. Further processing the data for your own commercial or research objectives are examples of an incompatible purpose in these circumstances
17. International Travel Test kit delivery and administration
Day 2 test kits must be delivered (or administered, where the provider is supplying a swabbing service) on or before day 2 after the traveller has arrived in England.
18. Turnaround time
Within 24 hours of getting a traveller’s evidence of the international travel test result, providers must:
- notify UKHSA of the lateral flow test outcome for all outcome types
- notify the traveller of their test result either by email, letter, or text message or
- let the traveller access their test result on a secure web portal
The messages in which providers tell travellers their test results must include the traveller’s:
- name
- date of birth
- passport number or travel document reference number
- chosen test provider’s name and contact details
- unique test booking reference number
The message must use UKHSA’s words as stated in section 14 of this guidance.
19. Provider accreditation requirements: Only required for organisations providing sample collection and/or point-of-care testing services. This requirement does not prevent issue of international travel tests which are self-swabbed or self-administered since those samples would be taken under instruction from the person responsible for taking the samples.
- Providers must be or use a United Kingdom Accreditation Service (UKAS) accredited or applicant point-of-care testing (POCT) provider ISO standards ISO 15189 and ISO 22870.
- Samples must be taken by a provider (or subcontractor, if relevant) who is UKAS accredited or an applicant to ISO standard ISO 15189 or ISO/IEC 17025. This requirement does not prevent issue of tests which are self-swabbed or self-administered since those samples would be taken under instruction from the person responsible for taking the samples.
- Additionally, providers are encouraged to adhere to ISO 22583 ‘Guidance for supervisors and operators of point-of-care testing (POCT) devices.
UKAS accreditation provides an assurance of the competence, impartiality and integrity of providers. This accreditation is an important element in establishing and maintaining confidence in a testing service.
For point-of-care testing, providers need to meet ISO standards ISO 15189 and ISO 22870 ‘point-of-care testing (POCT) – requirements for quality and competence’. These ISO standards and technical specifications set out the key components that should be considered to provide safe and reliable POCT service. Providers are encouraged to adhere to ISO 22583 ‘Guidance for supervisors and operators of point-of-care testing (POCT) devices’. Samples must also be taken by or under the written instruction of, a provider (and their subcontractors, if relevant) that is applicant to ISO 15189 or ISO/IEC 17025. This requirement does not prevent issue of tests which are self-swabbed or self-administered since those samples would be taken under written instruction from the person responsible for taking the samples.
UKAS appraisal status (‘stage 2’) is mandatory for commercial providers of COVID-19 testing 4 weeks after they become a UKAS applicant and have self-declared on the GOV.UK website confirming they meet minimum requirements. UKAS appraisal status is an assessment of compliance with the minimum requirements published by DHSC for fulfilment of stage 2. UKAS accreditation (‘stage 3’), which is full accreditation to the relevant ISO standard, requires the provider to receive a positive recommendation from UKAS within 4 months of completing stage 2 (that is, the date on which the organisation submitted evidence to UKAS demonstrating compliance with the UKAS appraisal requirements) and achieve full accreditation within 6 months after completing stage 2 UKAS appraisal.
Source: Gov.uk
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