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

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.