text: (iii) a limit of detection of less than or equal to 1000 SARS-CoV-2 copies per millilitre, 
  and 
  
  (iv) uses an established molecular detection method; 
  
  (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, 
  
  (ii) has been validated no more than 18 months before the test is administered or 
  provided to P; 
  
  (d) it is not a test provided or administered under the National Health Service Act 2006, the 
  National Health Service (Wales) Act 2006(**a**), the National Health Service (Scotland) Act 
  1978(**b**), or the Health and Personal Social Services (Northern Ireland) Order 1972(**c**); 
  and 
  
  (e) the test provider complies with paragraph 3. 
  
  (2) For the purposes of sub-paragraph (1), “validated”, in relation to a device, means confirmed 
  as having 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 for laboratory based SARS-CoV-2 PCR tests, by— 
  
  (a) the Secretary of State; 
  (b) a laboratory which is accredited to ISO standard 15189 or ISO/IEC standard 17025(**d**) 
  
  by— 
  (i) the United Kingdom Accreditation Service(**e**) (“UKAS”), or 
  (ii) an accreditation body that is a signatory to the International Laboratory Accreditation 
  Cooperation (“ILAC”) Mutual Recognition Arrangement(**f**) or the European co- 
  operation for Accreditation (“EA”) Multilateral Agreement(**g**), 
  
  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 or the device manufacturer. 
  (**h**); or 
  
  (c) a laboratory which is accredited by UKAS to ISO standard 15189 or ISO/IEC standard 
  17025(**i**), 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 or the device manufacturer. 