18. Schedule 2A is amended as follows—
(a)in the heading, for “Testing” substitute “ Optional testing ”;
(b)in paragraph 1 after “to self-isolate” insert “ other than in accordance with Schedule B1A ”;
(c)for paragraph 2(1)(b)(i) substitute—
“(i)a sensitivity greater than 95% (with 95% two-sided confidence interval entirely above 90%);”;
(d)for paragraph 2(1)(b)(ii) substitute—
“(ii)a specificity greater than 95% (with 95% two-sided confidence interval entirely above 90%);”;
(e)in paragraph 2—
(i)in sub-paragraph (1)(b)(ii) omit “and”;
(ii)at the end of sub-paragraph (1)(b)(iii) insert “ and ”;
(iii)after sub-paragraph (1)(b)(iii) insert—
“(iv)uses an established molecular detection method.”
(iv)omit sub-paragraph (1)(c)(iii);
(v)in the introductory words to sub-paragraph (2)(d) for the words from “a sensitivity of at least” to “250 negative samples” substitute—
“the required sensitivity and specificity using at least 150 positive clinical samples and 250 negative clinical samples against a laboratory-based RT-PCR test that is itself within the performance specification of the target product profile published by the Medicines and Healthcare Products Regulatory Agency M1 for laboratory based SARS-CoV-2 PCR tests”;
(vi)in sub-paragraph (2)(d)(iii) at the end insert “ or the device manufacturer ”;
(f)in paragraph 4(a), for the words “last departed” to the end substitute “ arrived in England ”;
(g)in paragraph 5(3), in Form B (positive test result)—
(i)in the second paragraph for “your test date” substitute the day after your test date”;
(ii)in the third paragraph for “the day you” substitute “ the day after you ”.
Commencement Information
I1Reg. 18 in force at 15.2.2021 at 4.00 a.m., see reg. 1(1)
Marginal Citations
M1The target product profile was published on 20 January 2021 and is available at https://www.gov.uk/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/target-product-profile-antibody-tests-to-help-determine-if-people-have-recent-infection-to-sars-cov-2-version-2