The Health Protection (Coronavirus, International Travel and Operator Liability) (England) Regulations 2021

Regulation 6(10)

SCHEDULE 8 Mandatory testing after arrival in England

Interpretation of this Schedule

1.—(1) In this Schedule—

(a) “default self-isolation period” means—

(i) in the case of a non-Schedule 11 passenger, the period specified in paragraph (7)(a) of regulation 9 (requirement to self-isolate),

(ii) in the case of a Schedule 11 passenger, the period specified in paragraph 10(a) of Schedule 11;

(b) “mandatory test” means a day 2 test or a day 8 test within the meaning of regulation 6(12);

(c) “non-Schedule 11 passenger” means a person to whom regulation 9 applies;

(d) “P” means a person required to undertake a mandatory test under regulation 6 (requirement to book and undertake tests);

(e) “private provider” means a test provider other than a public provider;

(f) “public provider” means a test provider who provides or administers a test under the National Health Service Act 2006, the National Health Services (Wales) Act 2006, the National Health Service (Scotland) Act 1978, or the Health and Personal Social Services (Northern Ireland) Order 1972;

(g) “relevant self-isolation provisions” means—

(i) in relation to a Schedule 11 passenger, regulation 9 and Schedule 11,

(ii) in relation to a non-Schedule 11 passenger, regulation 9.

(2) Where this Schedule requires P to continue to self-isolate in accordance with the relevant self-isolation provisions—

(a) regulation 19 (offences and penalties) applies in relation to that requirement as it applies in relation to the relevant self-isolation provisions;

(b) such a requirement to self-isolate does not apply in respect of a person exempt from regulation 9.

Requirement to self-isolate on failure to undertake a mandatory test

2.—(1) Sub-paragraph (2) applies where P is not a person of the description in regulation 5(1)(b), (c) or (d) and—

(a) either—

(i) P fails to undertake a day 2 test, or

(ii) P’s day 2 test generates a negative or inconclusive result, and

(b) P fails to undertake a day 8 test.

(2) Where this sub-paragraph applies, P must continue to self-isolate in accordance with the relevant self-isolation provisions until the end of the 14th day after the day on which they arrived in England.

(3) Sub-paragraph (4) applies where P is a person of the description in regulation 5(1)(b), (c) or (d) and P fails to undertake a day 2 test.

(4) Where this sub-paragraph applies, P must self-isolate in accordance with regulation 2 of the Self-Isolation Regulations as if P had been notified under regulation 2A(1)(a) of those Regulations, on the date that P should have undertaken the day 2 test, that P had tested positive, until the earlier of —

(a) the end of the 14th day after the day P arrived in England; or

(b) the time that P is notified of the result of a test meeting the requirements of a day 2 test save as to the time at which that test is to be undertaken, that P has undertaken.

(5) Sub-paragraph (6) applies where P is a person of the description in regulation 5(1)(b), (c) or (d) and P fails to undertake a day 8 test.

(6) Where this sub-paragraph applies, P must self-isolate in accordance with regulation 2 of the Self-Isolation Regulations as if P had been notified under regulation 2A(1)(a) of those Regulations, on the date that P should have undertaken the day 8 test, that P had tested positive, until the earlier of—

(a) the end of the 14th day after the day P arrived in England; or

(b) the time that P is notified of the result of a test meeting the requirements of day 8 test save as to the time at which the test is undertaken, that P has undertaken.

(7) If the result notified to P of a test of the description in sub-paragraph (4)(b) or (6)(b) is a positive result, P must self-isolate in accordance with regulation 2 of the Self-Isolation Regulations until the end of the 10th day after the day P arrived in England.

(8) Where P undertakes a test to which paragraph 3(7)(b) applies and which generates—

(a) a positive result, paragraph 3(1) applies as if the test were a mandatory test;

(b) a negative result, paragraph 3(4) applies as if—

(i) P had taken both a day 2 test and a day 8 test, and

(ii) both tests had generated a negative result.

Consequences of test results

3.—(1) Subject to paragraphs 4 (optional tests) and 5 (tests other than in accordance with these Regulations), where a mandatory test undertaken by P in accordance with regulation 6 generates a positive result—

(a) the following do not apply in relation to P—

(i) regulation 9(11)(a) or, as the case may be, paragraph 13(1)(a) of Schedule 11 (leaving self-isolation to travel in order to leave England),

(ii) subject to sub-paragraph (2), regulation 2A (requirements on person notified of positive test) of the Self-Isolation Regulations; and

(b) P and, subject to sub-paragraph (3), any person who is self-isolating with P must continue to self-isolate in accordance with the relevant self-isolation provisions until the end of the 10th day after the day P undertook the test.

(2) Regulation 2A of the Self-Isolation Regulations continues to apply to a person within regulation 5(1)(a), (c), (d), (e), (2) and (6).

(3) Where a person (“B”) is self-isolating with P pursuant to the relevant self-isolation provisions, the requirement to self-isolate under sub-paragraph (1)(b) does not apply to B where—

(a) the test referred to in sub-paragraph (1) is P’s day 8 test; and

(b) B undertook a day 2 test that generated a positive result.

(4) Subject to paragraph 4, where P’s day 2 test and day 8 test both generate a negative result, P must continue to self-isolate in accordance with the relevant self-isolation provisions until the later of—

(a) the end of the default self-isolation period;

(b) the day on which P receives the result of their day 8 test.

(5) Where a mandatory test undertaken by P generates an inconclusive result P must continue to self-isolate in accordance with the relevant self-isolation provisions—

(a) until the end of the 10th day after the day P undertook the test;

(b) where P undertakes a test to which sub-paragraph (7) applies and the test generates a negative result, until the later of—

(i) the end of the default self-isolation period,

(ii) the day on which P receives the negative result; or

(c) where P undertakes a test to which sub-paragraph (7) applies and the test generates a positive result, until the end of the 10th day after the day P undertook the test.

(6) Where sub-paragraph (5)(c) applies, P is not required to undertake a day 8 test in accordance with regulation 6.

(7) This sub-paragraph applies to—

(a) a day 8 test;

(b) a test—

(i) complying with the requirements for a day 8 test specified in paragraphs 8 and 9 (other than the requirement in paragraph 9(1)(e) that the test be administered or provided to P no earlier than the end of the seventh day after the day on which P arrived in England),

(ii) undertaken in the circumstances specified in paragraph 10 (other than the circumstances in paragraph 10(2) about when a test must be undertaken), and

(iii) undertaken during the period specified in sub-paragraph (5)(a).

Optional tests

4.—(1) This paragraph applies where P—

(a) is a non-Schedule 11 passenger who is required to comply with regulation 9, and

(b) undertakes a day 2 test which generates a negative or inconclusive result.

(2) P may undertake a test in accordance with Schedule 10 (optional testing after arrival in England), and, where the test generates a negative result, P ceases to be required to self-isolate from the time that P is notified of that result.

(3) P must in any event undertake the day 8 test booked in accordance with regulation 6.

(4) Where P ceases to be required to self-isolate under these Regulations in accordance with regulation 9(16), paragraph 3(1), (4) and (5) do not apply in relation to P’s day 8 test.

Tests other than in accordance with these Regulations

5.—(1) This paragraph applies where—

(a) P is a non-Schedule 11 passenger;

(b) P undertakes a day 2 test which generates a negative result;

(c) while P is self-isolating under these Regulations, P subsequently undertakes a test other than in accordance with these Regulations; and

(d) P is notified that such test generates a positive result.

(2) P ceases to be required to self-isolate in accordance with these Regulations, and regulation 2A of the Self-Isolation Regulations applies in relation to P.

Day 2 tests: general test requirements

6.—(1) For the purposes of regulation 6(12)(a), a day 2 test complies with this paragraph where—

(a) it is a test provided by a public provider; or

(b) it is a test provided by a private provider—

(i) in respect of—

(aa) a non-Schedule 11 passenger, on or after 1st March 2021;

(bb) a Schedule 11 passenger, on 1st or 2nd March 2021,

(ii) where the test complies with sub-paragraph (2), and

(iii) where the private provider complies with paragraph 7.

(2) A test complies with this sub-paragraph where—

(a) it is a semi-quantitative test for the detection of coronavirus which—

(i) targets a minimum of two distinguishable SARS-CoV-2 genes other than the S gene and performance reference controls,

(ii) includes routine in silico assurance against every variant of concern, and

(iii) produces a test solution that provides extracted nucleic acid that is suitable for whole genome sequencing using a specified method;

(b) it is, in relation to a Schedule 11 passenger, a test that can be self-administered;

(c) the manufacturer of any device used for the purposes of the test states that the device—

(i) uses an established molecular detection method,

(ii) has a specificity and a sensitivity greater than 99% (with a 95% two-sided confidence interval entirely above 97%),

(iii) has a limit of detection of less than or equal to 1000 SARS-CoV-2 copies per millilitre, and

(iv) is suitable for identifying every variant of concern; and

(d) any device used for the purposes of the test—

(i) can 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, and

(ii) has been validated no more than 18 months before the test is administered or provided to P.

(3) For the purposes of sub-paragraph (2)—

(a) “specified method” means a targeted sequence method specific to SARS-CoV-2 or an equivalent—

(i) amplicon method, or

(ii) sequence bait capture method;

(b) “validated”, in relation to a device, has the meaning given by paragraph 2(2) of Schedule 10;

(c) “variant of concern” means a variant of SARS-CoV-2 identified in a designation made by the Secretary of State for the purposes of this paragraph and published in a manner as appears to the Secretary of State to be appropriate.

Day 2 tests: private provider requirements

7.—(1) For the purposes of paragraph 6(1)(b)(iii), a private provider complies with this paragraph where—

(a) they comply with the requirements of paragraph 3(1)(a) and (e) to (h) of Schedule 10 as if any reference in those provisions to an appropriate test were a reference to a day 2 test;

(b) if the provider is a laboratory that conducts diagnostic test evaluation for testing in accordance with this Schedule, they have made a declaration to the Department of Health and Social Care that they meet the minimum standards for private sector-provided testing at https://support-covid-19-testing.dhsc.gov.uk/InternationalTesting;

(c) they have provided the Department of Health and Social Care with a list of all organisations that they work with (whether by sub-contract or otherwise) to carry out the testing service or to carry out genomic sequencing, indicating the nature of the service that each organisation is providing, and kept that list updated as appropriate;

(d) the person responsible for the taking of samples meets the relevant requirements for accreditation to ISO standard 15189 or ISO/IEC standard 17025 in respect of the taking of samples;

(e) the laboratory used by the test provider for the processing of samples meets the relevant requirements for ISO standard 15189 or ISO/IEC standard 17025 in respect of the evaluation of the established molecular detection method and the genomic sequencing of samples;

(f) they receive the information required by paragraph 10(3) or (4) (as appropriate), and if they administer the test to P, they do so no later than the end of the second day after the day on which P arrived in England;

(g) each day, they notify the Secretary of State in writing of—

(i) the number of tests they sold on that day, and

(ii) in relation to each test sold on that day—

(aa) the date of the arrival in England of the person in respect of whom the test was sold, and

(bb) whether the person in respect of whom the test was sold is a category 1 arrival or not;

(h) they sequence each sample with a cycle threshold less than 30 (equivalent to ~1,000 viral genome copies per millilitre);

(i) in respect of the sequencing of samples, they must secure a reference genome coverage breadth of at least 50% and at least 30 times coverage;

(j) on a request by the Secretary of State or the COVID-19 Genomics UK Consortium, they make samples available for the purpose of dual sequencing;

(k) they preserve and transport samples in a manner that enables genome sequencing;

(l) they have in place a process to remove human reads from any data submitted in a notification to Public Health England pursuant to the Health Protection (Notification) Regulations 2010; and

(m) if they arrange with another person (“X”) for X to carry out any element of the single end-to-end testing service on their behalf, the test provider ensures that X complies with the following so far as relevant to the carrying out of that element—

(i) paragraph 3(1)(e) to (h) of Schedule 10 as applied by paragraph (a) of this sub-paragraph,

(ii) paragraph (c) to (l) of this sub-paragraph,

(iii) paragraph 11(2), (3) and (4).

(2) For the purposes of sub-paragraph (1)(m), “single end-to-end testing service” has the meaning given in paragraph 3(2)(c) of Schedule 10.

(3) For the purposes of sub-paragraph (1)(d) and (e), a person or laboratory (as the case may be) meets the relevant requirements for accreditation to a standard where the person who is the operator of the laboratory complies with the requirements of regulation 6 of the Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020 as if—

(a) a reference to an applicable test were a reference to a day 2 test;

(b) a reference to a test provider were a reference to a private provider.

Day 8 tests: general test requirements

8.—(1) For the purposes of regulation 6(12)(b), a day 8 test complies with this paragraph where—

(a) it is a test provided by a public provider; or

(b) it is a test provided by a private provider—

(i) in respect of—

(aa) a non-Schedule 11 passenger, on or after 1st March 2021;

(bb) a Schedule 11 passenger, on 1st or 2nd March 2021,

(ii) where the test complies with sub-paragraph (2), and

(iii) where the private provider complies with paragraph 9.

(2) A test complies with this sub-paragraph where—

(a) it is a semi-quantitative test for the detection of coronavirus which targets a minimum of two distinguishable SARS-CoV-2 genes other than the S gene and performance reference controls;

(b) it is, in relation to a Schedule 11 passenger—

(i) a test which requires laboratory processing, and

(ii) a test which can be self-administered;

(c) the manufacturer of any device used for the purposes of the test states that the device—

(i) uses an extracted molecular method,

(ii) has a specificity and a sensitivity greater than 95% (with a 95% two-sided confidence interval entirely above 90%), and

(iii) has a limit of detection of less than or equal to 1000 SARS-CoV-2 copies per millilitre; and

(d) any device used for the purposes of the test—

(i) can 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, and

(ii) has been validated no more than 18 months before the test is administered or provided to P.

(3) For the purposes of sub-paragraph (2) “validated”, in relation to a device, has the meaning given by paragraph 2(2) of Schedule 10.

Day 8 tests: private provider requirements

9.—(1) For the purposes of paragraph 8(1)(b)(iii), a private provider complies with this paragraph where—

(a) they comply with the requirements of paragraph 3(1)(a) and (e) to (h) of Schedule 10 as if any reference in those provisions to an appropriate test were a reference to a day 8 test;

(b) if the provider is a laboratory that conducts diagnostic test evaluation for testing in accordance with this Schedule, they have made a declaration to the Department of Health and Social Care that they meet the minimum standards for private sector-provided testing at https://support-covid-19-testing.dhsc.gov.uk/InternationalTesting;

(c) they have provided the Department of Health and Social Care with a list of all organisations that they work with (whether by sub-contract or otherwise) to carry out the testing service or to carry out genomic sequencing, indicating the nature of the service that each organisation is providing and kept that list updated as appropriate;

(d) in relation to a test which requires laboratory processing—

(i) the person responsible for the taking of samples meets the relevant requirements for accreditation to ISO standard 15189 or ISO/IEC standard 17025 in respect of the taking of samples, and

(ii) the laboratory used by the test provider for the processing of samples meets the relevant requirements for accreditation to ISO standard 15189 or ISO/IEC standard 17025 in respect of the processing of samples;

(e) in relation to a point of care test, they meet the relevant requirements for accreditation to ISO Standard 15189 and ISO standard 22870;

(f) they receive the information required by paragraph 10(3) or (4) (as appropriate), and if they administer the test to P, they do so no earlier than the end of the seventh day after the day on which P arrived in England;

(g) each day, they notify the Secretary of State in writing of—

(i) the number of tests they sold on that day, and

(ii) in relation to each test sold on that day—

(aa) the date of arrival in England of the person in respect of whom the test was sold, and

(bb) whether the person in respect of whom the test was sold is a category 1 arrival or not;

(h) if they arrange with another person (“X”) for X to carry out any element of the single end-to-end testing service on their behalf, the test provider ensures that X complies with the following so far as relevant to the carrying out of that element—

(i) paragraph 3(1)(e) to (i) of Schedule 10 as applied by paragraph (a) of this sub-paragraph,

(ii) paragraph (b) to (g) of this sub-paragraph,

(iii) paragraph 11(2), (3) and (4).

(2) For the purposes of sub-paragraph (1)(h), “single end-to-end testing service” has the meaning given in paragraph 3(2)(c) of Schedule 10.

(3) For the purposes of sub-paragraph (1)(d) and (e), a person or laboratory (as the case may be) meets the relevant requirements for accreditation to a standard where the person who is the operator of the laboratory complies with the requirements of regulation 6 of the Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020 as if—

(a) a reference to an applicable test were a reference to a day 8 test;

(b) a reference to a test provider were a reference to a private provider.

Required circumstances for undertaking a day 2 test or a day 8 test

10.—(1) The circumstances mentioned in regulation 6(12)(a) and (b) are as follows.

(2) In relation to—

(a) a day 2 test, P undertakes the test no later than the end of the second day after the day on which P arrived in England;

(b) a day 8 test, P undertakes the test no earlier than the end of the seventh day after the day on which P arrived in England.

(3) Subject to sub-paragraph (4), at the time the test is booked P notifies the test provider that P is to undertake the test under these Regulations, and provides the test provider with—

(a) the information set out in paragraph 4(b)(i) to (v) and (vii) to (xiii) of Schedule 10; and

(b) their home address, and—

(i) where P is a person to whom regulation 9(1)(a) or (b) applies, the address or addresses at which they intend to self-isolate, or are self-isolating, in accordance with regulation 9 (if different from their home address), or

(ii) where P is a person to whom regulation 10 applies, the address of the accommodation designated for the purposes of Schedule 11.

(4) Where P is a child, or a person with a disability who is unable for that reason to provide the notification and information set out or referred to in sub-paragraph (3) to the test provider—

(a) the notification and information set out or referred to in sub-paragraph (3), other than the information set out in paragraph 4(b)(xi) and (xii) of Schedule 10, is provided to the test provider on P’s behalf by another person (“Y”); and

(b) either the information set out in paragraph 4(b)(xi) and (xii) of Schedule 10 is provided by Y to the test provider or, where appropriate, Y provides their own telephone number and email address to the test provider.

(5) At the time the test is booked and payment made the test provider gives P a test reference number in the format specified in sub-paragraph (6) and, where appropriate, also provides that test reference number to Y.

(6) A test reference number must consist of 12 characters comprising 5 letters followed by 7 digits.

Notification of test results

11.—(1) This paragraph applies to a private provider who administers or provides a test to P in the circumstances described in paragraph 10.

(2) The private provider must, within 24 hours of the result becoming available—

(a) notify P or, where paragraph 10(4) applies, Y by email, letter, or text message, of the result of P’s test; or

(b) make P’s test result available to P, or where paragraph 10(4) applies, to Y via a secure web portal,

in accordance with sub-paragraph (3).

(3) The notification of P’s test result must include P’s name, date of birth, passport number, or travel document reference number (as appropriate), the name and contact details of the test provider and P’s test reference number, and must be conveyed using one of the following forms of words, as appropriate—

Form A: negative 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 quarantine if you are travelling from a green-list country. If you are travelling from an amber list country and took the test on or before 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 and are travelling from an amber-list country 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’.

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 or variant under investigation.

People you live with or have travelled 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 you do not need to take any further tests. People you are travelling with must still take a day 8 test if they have travelled from an amber list country.

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.

(4) Where—

(a) regulation 4 or 4A of the Health Protection (Notification) Regulations 2010 applies in relation to the test provider; or

(b) if the test provider arranges with another person (“X”) for X to carry out any element of the single end-to-end testing service on their behalf, either of those regulations applies to X in the carrying out of that element,

the regulation applies as if it required the information described in sub-paragraph (5) to be included in the notification to Public Health England.

(5) The information mentioned in sub-paragraph (4) is—

(a) the date on which P last departed from or transited through a category 2 country or territory;

(b) P’s coach number, flight number or vessel name (as appropriate);

(c) the country or territory P was travelling from when P arrived in England, and any country or territory they transited through as part of that journey;

(d) the date on which P undertook the appropriate test;

(e) whether the test is—

(i) a day 2 test for a category 1 arrival,

(ii) a day 2 test for a person who is not a category 1 arrival, or

(iii) a day 8 test.

Charge for day 2 tests and day 8 tests

12.—(1) The Secretary of State or a person designated by the Secretary of State may impose a charge in respect of mandatory tests provided by a public provider.

(2) The Secretary of State—

(a) must publish details of the charges in such manner as the Secretary of State considers appropriate; and

(b) may recover any sum owed by a person pursuant to such a charge as a debt.