The Health Protection (Coronavirus) (International Travel and Operator Liability) (Scotland) Amendment (No. 13) Regulations 2021

Amendment of regulation 14

7.  In regulation 14 (requirement to undertake tests)—

(a) for paragraph (9A) substitute—

“(9A) For the purposes of paragraph (9)(b), 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(1), 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.”,

(b) after paragraph (11), insert—

“(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(2) by—

(aa) the United Kingdom Accreditation Service(3), or

(bb) an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (“ILAC”) Mutual Recognition Arrangement(4) or the European co-operation for Accreditation (“EA”) Multilateral Agreement(5),

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(6),

(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(7).”.

(1)

S.I. 2002/618, relevantly amended by S.I. 2019/791 and S.I. 2020/1478.

(2)

ISO standards are published in Geneva by the International Organisation for Standardisation, and are available on their website (www.iso.org) or at ISO Central Secretariat, International Organization for Standardization (ISO), 1 rue de Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland. ISO 15189 Medical Laboratories requirements for quality and competence was published in November 2012. ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories was published in November 2017.

(3)

The United Kingdom Accreditation Service is a company limited by guarantee incorporated in England and Wales under number 3076190.

(4)

ILAC is an international organisation which coordinates the work of its signatory national accreditation bodies which are themselves involved in the accreditation of conformity assessment bodies, testing laboratories, and medical testing laboratories.

(5)

EA is a regional organisation which coordinates the work of its signatory national accreditation bodies. EA is recognised by and works closely with ILAC.

(6)

A body corporate established under section 232 of the Health and Social Care Act 2012 (c. 7).

(7)

Technical briefing documents on novel SARS-CoV-2 variants are published by the UK Health Security Agency and are available online at https://www.gov.uk/government/publications/investigation-of-sars-cov-2-variants-technical-briefings.