F1SCHEDULE 1CMandatory testing after arrival in Wales
Interpretation
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.