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

Requirement to undertake tests S

14.—(1) P must undertake the test or tests in their testing package in accordance with this regulation.

[F1 (1A) If a test is to be self-administered, P must undertake a test in accordance with the manufacturer’s instructions for use.]

(2) P must undertake the day 2 test no later than the end of the 2nd day after the day on which P arrived in Scotland.

(3) Where P's day 2 test generates a positive result and P would otherwise be required to take the day 8 test, P is not required to undertake the day 8 test.

(4) Where P is required to undertake the day 8 test, P must undertake that test no earlier than the end of the 7th day after the day on which P arrived in Scotland.

(5) Where P is a child aged 11 or over, any person who has responsibility for P must, so far as reasonably practicable ensure that P undertakes a day 2 test and, where relevant, a day 8 test.

(6) Where P does not undertake either a day 2 test or a day 8 test by reason of a reasonable excuse (see regulation 30), P must, as soon as practicable after the matters giving rise to the reasonable excuse no longer apply, undertake a replacement test complying with the requirements of paragraph (9).

(7) Where a replacement test is undertaken instead of—

(a) a day 2 test, P is to be treated as if P had undertaken a day 2 test in accordance with this regulation,

(b) a day 8 test, P is to be treated as if P had undertaken a day 8 test in accordance with this regulation.

(8) Where a test is undertaken by P after this regulation applies, and that test meets the requirements of paragraph (9) and generates a positive result, P is not required to undertake a subsequent day 2 test or day 8 test, as the case may be.

(9) The requirements of this regulation are that—

(a) the test is provided by a public provider, or where P is [F2 not a red] list arrival, a public provider or a private provider, and

[F3 (b) the test is a test which complies with paragraph (9A)]

[F4 [F5 (9A) For the purposes of paragraph (9)(b)(i), a test complies with this paragraph if—

(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 red list arrival, 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) in relation to a day 2 test, has a specificity and a sensitivity greater than or equal to 99% (or a 95% two-sided confidence interval entirely above 97%),

(iii) in relation to a day 8 test, has a specificity greater than or equal to 97% (or a 95% two-sided confidence interval entirely above 95%),

(iv) in relation to a day 8 test, has a sensitivity greater than or equal to 95% (or a 95% two-sided confidence interval entirely above 90%),

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

(vi) 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.]

F6 (9B) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

(10) In this regulation, “public provider” means a test provider who provides or administers a test under—

(a) the National Health Service (Scotland) Act 1978,

(b) the National Health Service Act 2006,

(c) the National Health Service (Wales) Act 2006, or

(d) the Health and Personal Social Services (Northern Ireland) Order 1972.

(11) In this regulation “private provider” means a day 2 test and a day 8 test provider, other than a public provider, who—

(a) has made a self-declaration to the Department of Health and Social Care that the provider meets the minimum standards that private sector providers must meet for coronavirus tests for persons arriving in England in terms of schedule 8 to the Health Protection (Coronavirus, International Travel and Operator Liability) (England) Regulations 2021 M1 and DHSC guidance, and

(b) is currently on the UK Government published list of private day 2 test and day 8 test providers for persons arriving in England M2 .

[F7 (12) For the purposes of paragraph (9A)—

(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, means confirmed 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 performance specification of the target product profile published by the Medicines and Healthcare Products Regulatory Agency for laboratory based SARS-CoV-2 PCR tests, by—

(i) the Secretary of State, or

(ii) a laboratory which is accredited to ISO standard 15189 or ISO/IEC standard 17025 by—

(aa) the United Kingdom Accreditation Service, or

(bb) an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (“ILAC”) Mutual Recognition Arrangement or the European co-operation for Accreditation (“EA”) Multilateral Agreement,

other than a laboratory which processes tests provided by the test provider for the purposes of this Part or which is owned by the test provider or the device manufacturer.

(c) “variant of concern” means a variant of SARS-CoV-2 identified in a designation published by the UK Health Security Agency for the purposes of this  paragraph.]

Textual Amendments

F1 Reg. 14(1A) inserted (31.10.2021 at 4.00 a.m.) by The Health Protection (Coronavirus) (International Travel and Operator Liability) (Scotland) Amendment (No. 6) Regulations 2021 (S.S.I. 2021/382), regs. 1(2), 3(2)

F2 Words in reg. 14(9)(a) substituted (4.10.2021 at 4.00 a.m.) by The Health Protection (Coronavirus) (International Travel and Operator Liability) (Scotland) Amendment (No. 3) Regulations 2021 (S.S.I. 2021/350), regs. 1, 6(3) (with reg. 17)

F3 Reg. 14(9)(b) substituted (30.11.2021 at 4.00 a.m.) by The Health Protection (Coronavirus) (International Travel and Operator Liability) (Scotland) Amendment (No. 10) Regulations 2021 (S.S.I. 2021/443), regs. 1, 5(a) (with reg. 12)

F4 Reg. 14(9A) substituted (22.11.2021 at 4.00 a.m.) by The Health Protection (Coronavirus) (International Travel and Operator Liability) (Scotland) Amendment (No. 7) Regulations 2021 (S.S.I. 2021/425), regs. 1, 7(a) (with reg. 13)

F5 Reg. 14(9A)(9B) inserted (31.10.2021 at 4.00 a.m.) by The Health Protection (Coronavirus) (International Travel and Operator Liability) (Scotland) Amendment (No. 6) Regulations 2021 (S.S.I. 2021/382), regs. 1(2), 3(4)

F6 Reg. 14(9B) omitted (30.11.2021 at 4.00 a.m.) by virtue of The Health Protection (Coronavirus) (International Travel and Operator Liability) (Scotland) Amendment (No. 10) Regulations 2021 (S.S.I. 2021/443), regs. 1, 5(b) (with reg. 12)

F7 Reg. 14(12) inserted (22.11.2021 at 4.00 a.m.) by The Health Protection (Coronavirus) (International Travel and Operator Liability) (Scotland) Amendment (No. 7) Regulations 2021 (S.S.I. 2021/425), regs. 1, 7(b) (with reg. 13)

Commencement Information

I1 Reg. 14 in force at 20.9.2021, see reg. 1(2)

Marginal Citations

M1 S.I. 2021/582. Relevant amending instruments to schedule 8 are S.I. 2021/682, S.I. 2021/865 and S.I. 2021/914.

M2 The list can be accessed through this web-site: https://www.gov.uk/find-travel-test-provider.