F1SCHEDULE 2AF8Testing after arrival in England

Annotations:
Amendments (Textual)

Appropriate tests2

1

A test is an “appropriate test” where—

a

it is a test for the detection of coronavirus,

b

the manufacturer of any device used for the purposes of the test states that the device has—

i

a sensitivity of at least 97%,

ii

a specificity of at least 99%, and

iii

a limit of detection of less than or equal to 1000 SARS-CoV-2 copies per millilitre,

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,

ii

has been validated no more than 18 months before the test is administered or provided to P,

iii

is suitable to be used to administer or provide a test to a person of P’s age,

d

it is not a test provided or administered under the National Health Service Act 2006, the National Health Services (Wales) Act 2006, the National Health Service (Scotland) Act 1978, or the Health and Personal Social Services (Northern Ireland) Order 1972, and

e

the test provider complies with paragraph 3.

2

For the purposes of sub-paragraph (1)—

F5a

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F6b

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F7c

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

d

“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 Secretary of State,

ii

the National Institute for Health and Care ExcellenceF2, or

iii

a laboratory which is accredited by the United Kingdom Accreditation ServiceF3 (“UKAS”) to ISO standard 15189 or ISO/IEC standard 17025F4, 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.