The Health Protection (Coronavirus, International Travel) (Wales) Regulations 2020

Regulation 6B

[F1 SCHEDULE 1C E+W Mandatory testing after arrival in Wales

Textual Amendments

F1 Sch. 1C inserted (15.2.2021 at 4.00 a.m.) by The Health Protection (Coronavirus, International Travel) (Wales) (Amendment) (No. 3) Regulations 2021 (S.I. 2021/154), regs. 1(2), 4 (with reg. 21)

Day 2 test requirements E+W

1.   A day 2 test complies with this 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) 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

(c) 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.

Day 8 test requirements E+W

2.   A day 8 test complies with this 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) 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

(c) 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.

Interpretation E+W

3.   In this Schedule—

(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 a sensitivity of at least 97% and a specificity of at least 99% for at least 150 positive samples and 250 negative samples, by—

(i) the Welsh Ministers,

(ii) the National Institute for Health and Care Excellence, or

(iii) a laboratory which is accredited by the United Kingdom Accreditation Service (“UKAS”) to ISO standard 15189 or ISO/IEC standard 17025, other than a laboratory which processes tests provided by the test provider for the purposes of this Schedule or is owned by the test provider;

(c) “variant of concern” means a variant of SARS-CoV-2 identified in a designation made by the relevant expert UK Group (currently NERVTAG) for the purposes of these Regulations and published in a way that the Welsh Ministers consider to be appropriate.]