The Health Protection (Coronavirus, International Travel) (England) Regulations 2020 (revoked)

[F1Day 2 tests: general test requirementsE+W

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6.—(1) For the purposes of regulation 3B(11)(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—

[F2(i)in respect of—

(aa)a non-Schedule B1A arrival, on or after 1st March 2021;

(bb)a Schedule B1A arrival, on 1st or 2nd March 2021 or on or after 26th April 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 B1A 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)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.

(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)(d) of Schedule 2A;

(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.]

Textual Amendments