1A

If a test is to be self-administered, P must undertake a test in accordance with the manufacturer’s instructions for use.

b

the test is—

i

where P is a red list arrival or not an eligible vaccinated arrival, a test which complies with paragraph (9A),

ii

where P is an eligible vaccinated arrival, a test which complies with paragraph (9B).

9A

For the purposes of paragraph (9)(b)(i), a test complies with this paragraph if 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.

9B

For the purposes of paragraph (9)(b)(ii), a test complies with this paragraph if—

a

it is a test for the detection of coronavirus which uses one or more of—

i

mid-turbinate or anterior nares nasal swabbing,

ii

tonsillar swabbing,

iii

saliva,

b

the test is uniquely identifiable,

c

the test is provided in accordance with the test manufacturer’s instructions for use including, in particular, instructions as to the target use, target user and target use settings, and

d

any device used for the purposes of the test can be put into service in accordance with Part 4 of the Medical Devices Regulations 20023, other than solely by virtue of regulation 39(2) of those Regulations.