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

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Version Superseded: 09/01/2022

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[F1InterpretationE+W

3.  In this Schedule—

(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, 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 Welsh Ministers,

(ii)the National Institute for Health and Care Excellence, or

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

(c)“variant of concern” means a variant of SARS-CoV-2 identified in a designation made by the relevant expert UK Group (currently NERVTAG) for the purposes of these Regulations and published in a way that the Welsh Ministers consider to be appropriate.

[F2(d)“single end-to-end testing service” F3... means a service which comprises accepting the booking from the person to be tested, collecting and processing the sample to be tested, carrying out genomic sequencing and providing the test result to P.]]

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