61 
(2)  P ceases to be required to self-isolate in accordan ce with these Regulations, and regulation 
2A of the Self-Isolation Regulations applies in relation to P. 
Day 2 tests: general test requirements 
6. —(1) For the purposes of regulation 6(12)(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— 
(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 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 11 passenger, 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 1 000 SARS-CoV-2 copies per 
millilitre, and 
(iv)  is suitable for identifying every variant of concern; 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 th e 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 meani ng given by paragraph 2(2) of Schedule 
10; 
(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 par agraph and published in a manner as 
appears to the Secretary of State to be appropriate.