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The Health Protection (Coronavirus, International Travel) (Wales) Regulations 2020

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[F1[F2Day 2 tests: general requirements]E+W

1.—[F3(1) A day 2 test complies with this paragraph where the test complies with sub-paragraph (2) and—

(a)it is a test provided by a public test provider, or

(b)it is a test provided by a private test provider where the private test provider complies with paragraph 1ZA.]

[F4(2)] A day 2 test complies with this [F5sub-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)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 [F6or equal to] 99% ([F7or] 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.]

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