Introduction

All international arrivals to England must quarantine for 10 days, unless they have a job that qualifies for an exemption.

All international arrivals in quarantine are required to take a test on or before day 2 (of their quarantine period), for variant surveillance, and a test on or after day 8 (of their quarantine period).

Private providers may provide tests for day 2 and day 8 testing for international arrivals travelling from countries that do not have a travel ban (non ‘red list’ countries).

From 26 April, private providers may provide tests for day 2 and day 8 testing for international arrivals who have been in or transited through a ‘red list’ country in the 10 days before their arrival.

By law, all tests privately provided on day 2 and day 8 for international arrivals must meet minimum standards as outlined in the guidance below. The first section sets out minimum standards that apply for both day 2 and day 8 tests. The second section sets out additional specific standards for day 2 tests and the third section sets out additional specific standards for day 8 tests.

International arrivals who have arrived from countries that do not have a travel ban, non ‘red list’ countries, will still be able to opt in to Test to Release for international travel to shorten their quarantine period. Providers for Test to Release must also meet certain minimum standards.

Self-declaration

Providers must also complete a declaration that their tests meet all of these standards.

The laboratory completing the self-declaration will self-declare on behalf of themselves and all of the organisations they’re working with to provide these tests. You will need to list all organisations that you will be working with (whether by sub-contract or otherwise) in order to carry out this service. You will also need to list any organisations you will be working with (whether by sub-contract or otherwise) to carry out genomic sequencing.

If you wish to change the list of organisations you are working with to provide the service and/or genomic sequencing, you will need to notify the Department of Health and Social Care (DHSC) of the nature of the arrangement and the name of this organisation.

Minimum standards that apply to day 2 and day 8 tests

1. Requirement for a medical director and healthcare 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 medical practitioner or a healthcare 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 testing for 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
• for laboratory testing, a verification report for the laboratory element of the test (known as the assay), in line with national protocols (for laboratory-based testing)
• information management systems to monitor sample delivery and tracking
• systems to meet the provisions for handling, transportation and analysis of test samples
• for laboratory testing, working to containment level CL3 or CL2+ with Health and Safety Executive (HSE) approval
• systems, processes and record management to support the delivery of safe and reliable service

3. The test device must be 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 do not benefit from a derogation from those standards.

A CE mark is a logo that is placed on 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.

From 1 January 2021, a test with a UKCA mark can be used. Tests with a CE mark can be used until July 2023.

Further information is available on:

• CE marking
• UKCA marking
• in-vitro diagnostic medical devices

4. Reporting of coronavirus test results, as a notifiable disease

The provider must have a system in place for reporting positive, negative and inconclusive 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 becoming available.

More information is available in PHE guidance on the reporting of notifiable diseases.

At booking, the provider (or sub-contractor, if relevant) will need to have a system in place to collect the following data fields from international arrivals:

• full name
• sex
• date of birth
• NHS number (if known and applicable)
• ethnicity
• home address, including postcode, and the address at which they intend to quarantine (if different)
• email address
• telephone number
• vaccination status

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:

• the date of their arrival in the UK
• 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
• from 6 April 2021, the sample specimen ID number
• from 6 April 2021, whether the test was for day 2, day 8 or Test to Release

For day 2 tests, the following additional data must also be reported by the laboratory conducting genome sequencing:

• from 6 April 2021, the same sample specimen ID number reported by the diagnostic laboratory
• whether a variant of concern (VOC) has been identified
• whether a variant under investigation (VUI) has been identified

Definitions of VOCs and VUIs can be found in the PHE variant guidance.

5. Reporting test sales

You must complete a daily report that details your cumulative test sales for each date covering the following 14 days. Test bundle sales should be reported by the traveller’s date of arrival in England. If, from 6 April, an international arrival only purchases a day 2 test this can be reported as a single sale.

This will need to be filled in by each customer facing provider that is selling tests directly to international arrivals. If you are a laboratory selling tests directly to the public, you will also be required to fill in the number of tests you have sold directly to international arrivals for this purpose.

These reports will be required daily through the DHSC live form, provided to testing providers who meet minimum standards.

This information will not be used for any commercial purposes.

6. 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. Medicines & Healthcare products Regulatory Agency (MHRA) has a dedicated coronavirus (COVID-19) yellow card portal to report adverse incidents with medicines, medical devices and diagnostics.

7. Use of age-appropriate test devices

The test device should be age-appropriate, so it should be suitable to administer or provide a test to a person of the same age as the international arrival.

8. Sales of tests

Day 2 and day 8 tests may be sold separately from 6 April for international arrivals staying for fewer than 10 days, or as a single bundle including the day 2 and day 8 test. Where a test kit is broken, is not delivered or gives an inconclusive or invalid test result, the provider should offer a replacement test.

Genome sequencing must be included within the cost of any product that contains day 2 testing.

9. Reference number format

At the time the test bundle is booked, the test provider must provide a single test reference number to the person booking the test. If the provider sells multiple bundles to one person, each bundle will require its own booking reference.

From 6 April 2021, the booking reference must be in the format of:

• a 5-letter prefix unique to the provider, followed by
• a 7-digit suffix unique to the booking made by the international arrival

DHSC will issue the provider with a unique booking reference prefix for day 2 and day 8 testing during onboarding to the GOV.UK list.

10. Issuance of booking reference

From 6 April 2021, providers must only issue a booking reference to a customer once payment has been taken.

11. Sub-contractors or organisations you are working with

If the test provider arranges with another provider or person (for example a sub-contractor) 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 of the relevant minimum standards.

12. Notification of test result: providers must issue the result of tests in a set notification which instructs the international arrival on whether they are required to quarantine

Form A: negative test result

Your coronavirus (COVID-19) test result is negative. You did not have the virus when the test was done.

If you took the test on day 2 of your quarantine you must continue to quarantine until you have completed the 10-day quarantine period and received a negative test result for a test taken on day 8. If you took the test on day 8 you may stop quarantine when you have completed your 10-day quarantine period.

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
• you’re going into hospital (self-isolating until the date you go in)
• someone you live with tests positive
• you have been traced as a contact of someone who tested positive

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’.

It’s a legal requirement to quarantine when you arrive in England. If you are contacted by the enforcement authorities or the police after you have received this negative result please show them this notification.

Form B: positive test result

Your coronavirus test result is positive. You had the virus when the test was done.

Even if you have not had symptoms of coronavirus, you must self-isolate for 10 days from the day after your test date. Your test sample may be genome sequenced to check whether you have a virus variant of concern.

People you live with or are travelling with should also self-isolate for 10 days from the day after you took a test.

If you received a positive test result for the test taken on or before day 2, you do not need to take the day 8 test. People you are travelling with must still take a day 8 test.

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 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 take another test or self-isolate for 10 days from the day after your test date.

You may be contacted to check that you are self-isolating.

13. 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 FAQs on data collection and data protection relating to coronavirus (COVID-19) that provide further information, including GDPR considerations:

• Coronavirus (COVID-19) testing: guidance for employers and third-party healthcare providers
• ICO FAQs

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 individual’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 individual 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

14. Self-swabbing tests for individuals in managed quarantine facilities

Provider must provide self-swabbing tests to individuals in managed quarantine facilities.

Minimum standards specific to day 2 tests

1. Provider accreditation requirements

1. Providers must be or use a United Kingdom Accreditation Service (UKAS) accredited or applicant laboratory to ISO 15189 or ISO/IEC 17025 (Medical Laboratories – requirements for quality and competence) for the performance of molecular methods.
2. Providers must be or use a UKAS accredited or applicant laboratory to ISO 15189 or ISO/IEC 17025 for genome sequencing.
3. Additionally, samples must be taken by a provider (or sub-contractor, if relevant) who is UKAS accredited or an applicant to ISO standard ISO15189 or ISO/IEC 17025.

UKAS accreditation provides an assurance of the competence, impartiality and integrity of laboratories. This accreditation is an important element in establishing and maintaining confidence in a testing service.

For polymerase chain reaction (PCR) or other lab-based testing, all samples must be processed by a UKAS accredited or applicant laboratory (the laboratory is accredited or has applied for UKAS accreditation but has not yet achieved it) and have quality management systems operating according to ISO 15189 or ISO/IEC 17025. Samples must also be taken by or under the written instruction of, a provider (and their sub-contractors, 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’) became mandatory for commercial providers coronavirus (COVID-19) testing on 31 January 2021, or 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, will become mandatory for commercial coronavirus (COVID-19) testing by 1 July 2021, or 4 months after they have gained UKAS stage 2 appraisal status.

2. Use of tests that meet minimum performance characteristics

The provider must use established molecular detection methods that have been independently validated by a laboratory with a UKAS accredited SARS-COV-2 RT-PCR method, or an ISO15189 or ISO/IEC 17025 accredited laboratory with the following performance characteristics as a minimum:

• clinical sensitivity greater than 99% (or 95% 2-sided confidence interval entirely above 97%), and
• clinical specificity greater than 99% (or 95% 2-sided confidence interval entirely above 97%)
• limit of detection less than or equal to 1,000 SARS-CoV-2 copies per millilitre (≤1000 Copies/ml)

Specifically, the assay must have been independently validated as having the required sensitivity and specificity using at least 150 positive clinical samples and 250 negative clinical samples against a laboratory-based RT-PCR test that is itself within the within the performance specification of the MHRA TPP for laboratory based SARS-COV-2 PCR tests. The viral load of the 150 positive samples should span the dynamic range of the assay in equal proportions (high, medium and low CT values).

Independent validation must have been conducted, no more than 18 months before the test is provided, by one of:

• an independent laboratory which is accredited by UKAS to ISO 15189 or ISO/IEC 17025 for detection of SARS-Cov-2 virus RNA (an ‘independent laboratory’ is one that is independent of both the test manufacturer and the laboratory for which the validation is being conducted – i.e. the laboratory that will be sending this validation to DHSC through the self-declaration process)
• a scientific committee which is overseen by DHSC, including the Technologies Validation Group

Further guidance explaining how both virus and antibody tests work has been published by the MHRA.

3. Use of tests that are suitable for identification of SARS-COV-2 variants

The assay must be semi quantitative and include a minimum of 2 distinguishable SARS-COV-2 gene targets not including S gene or performance reference controls.

The assay should amplify more than one gene target in distinct regions and each gene target must be identifiable as a separate CT value or equivalent.

Must include routine in silico assurance against variants of concern.

The supplier should perform a minimum biweekly check of the amplification region and primer probes against new variants of concern reported by GISAID or Public Health England and report (within 48 hours) new variants that impact on the amplification target region, including primers, probs and amplicon.

The test solution must provide extracted nucleic acid that is suitable for whole genome sequencing using a specified method.

4. Targeted sequencing methods

Sequencing shall be performed using a targeted sequencing method specific to SARS-CoV-2 or equivalent amplicon or sequence bait capture methods.

An amplicon is defined as an amplified product of a PCR reaction.

Sequence bait capture is defined a method for enriching a sample for a target of interest before sequencing using long single stranded nucleotide sequence ‘baits’ that bind to complementary sequence in the target.

5. Data provision to MHRA confirming variant sequencing capability

The provider should ensure test manufacturers are providing data to the MHRA demonstrating the suitability of the device for identifying SARS-CoV-2 Variants of Concern.

6. Sequencing of samples with a <30 CT value

All samples with cycle threshold (CT) values of <30 (defined as equivalent to ~10,000-1,000 viral genome copies/ml) must be sequenced.

7. Coverage of genome sequencing

The percentage of target bases which should have been sequenced for a given number of times is set out below, as the coverage breadth:

1. All SARS-CoV-2 genomes must have minimal sequencing coverage of 50% at >= 30x coverage.
2. For samples with a CT <20, defined as viral genome copy number equivalent of <1,000,000 viral genome copies per ml, 95% of samples should have a reference genome coverage breadth of >97% at >=30x coverage.
3. For CT above 20, defined as viral genome copy number equivalent of >1,000 per ml, 95% of samples should have a reference genome coverage breadth of >75% at >=30x coverage.

8. Upload of BAM files

For sequenced samples, the provider must report a sorted BAM file containing all reads aligning to the SARS-CoV-2 reference genome with unaligned reads removed and human reads removed.

Upload of BAM files for sequenced samples will be required from 15 March.

Further information will be provided on reporting BAM files to PHE shortly.

9. Preservation and transport of test material

Provider must preserve and transport test material to support sequencing.

10. Removal of human reads

Provider must have a process in place to remove human reads from any data submitted to a public repository.

11. Availability of samples for dual sequencing

The provider must make samples available for dual sequencing on the request of NHS Test and Trace or the COVID-19 UK Genomics Consortium (COG-UK) and partake in assurance processes on request.

12. Date tests can be provided or administered

Providers must administer the tests to international arrivals within the first 2 days of their isolation period. The provider should base the start of the isolation period on the day the international arrival arrives in England as declared on their booking form, meaning that the day of arrival is day 0.

Tests delivered to managed quarantine facilities must be self-swabbed.

13. Turnaround time

The provider should report the viral genome within 72 hours of sample collection.

14. Requirement for a bioinformatician

The provider should have a bioinformatician supervising genome sequencing. The same individual that fulfils the medical director and/or clinical oversight roles may also fulfil this role.

Minimum standards specific to day 8 tests

1. Provider accreditation requirements

1. Providers must be or use a UKAS accredited or applicant laboratory to either ISO 15189 (Medical Laboratories – requirements for quality and competence) or ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories) for the performance of molecular methods.
2. Additionally, samples must be taken by a provider (or sub-contractor, if relevant) who is UKAS accredited or an applicant to ISO standard ISO15189 or ISO/IEC17025.

UKAS accreditation provides an assurance of the competence, impartiality and integrity of laboratories. This accreditation is an important element in establishing and maintaining confidence in a testing service.

For PCR or other lab-based testing, all samples must be processed by a UKAS accredited or applicant laboratory (the laboratory has is accredited or has applied for UKAS accreditation but has not yet achieved it) and have quality management systems operating according to ISO 15189 and/or ISO/IEC 17025. Samples must also be taken by or under the written instruction of, a provider (and their sub-contractors, if relevant) that is applicant to ISO 15189 and/ 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’) became mandatory for commercial providers COVID-19 testing on 31 January 2021, or 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, will become mandatory for commercial COVID-19 testing by 1 July 2021, or 4 months after they have gained UKAS stage 2 appraisal status.

2. Use of tests that meet minimum performance characteristics

The provider must use test devices with extracted molecular methods that have the following performance characteristics as a minimum:

• specificity greater than 95% (or 95% 2-sided confidence interval entirely above 90%)
• sensitivity greater than 95% (or 95% 2-sided confidence interval entirely above 90%)
• limit of detection less or equal to 1,000 SARS-CoV-2 copies per millilitre (≤1000 Copies/ml)

In addition, test devices must have been independently validated as having a sensitivity of at least 95% and a specificity of at least 95% for at least 150 positive clinical samples and 250 negative clinical samples against a RT-PCR test that is itself within the within the performance specification of the MHRA TPP for laboratory based SARS-COV-2 PCR tests. The viral load of the 150 positive samples should span the dynamic range of the assay in equal proportions (high, medium and low CT values).

Independent validation must have been conducted, no more than 18 months before the test is provided, by one of:

• an independent laboratory which is accredited by UKAS to ISO 15189 or ISO/IEC 17025 for detection of SARS-Cov-2 virus RNA (an ‘independent laboratory’ is one that is independent of both the test manufacturer and the laboratory for which the validation is being conducted – i.e. the laboratory that will be sending this validation to DHSC through the self-declaration process)
• a scientific committee which is overseen by DHSC, including the Technologies Validation Group.

Further guidance explaining how both virus and antibody tests work has been published by the MHRA.

3. Use of tests that are suitable for identification of SARS-COV-2 variants

The assay must be semi quantitative and include a minimum of 2 distinguishable SARS-COV-2 gene targets not including S gene or performance reference controls.

4. Date tests can be provided or administered

Providers may only provide or administer the day 8 tests to international arrivals on or after the eighth full day of their isolation period. The provider should base the start of the isolation period on the day the international arrivals arrives in England as declared on their booking form, meaning that the day of arrival is day 0.

Tests delivered to managed quarantine facilities must be self-swabbed.

5. Turnaround time

The provider should endeavour to provide test results within 48 hours of sampling.

Source: https://www.gov.uk/guidance/testing-on-day-2-and-day-8-for-international-arrivals