69 
(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 th e 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 (Nort hern 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 15 189 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 Agr eement( g), 
other than a laboratory which processes tests provi ded by the test provider for the 
purposes of this Schedule or is owned by the test p rovider or the device manufacturer. 
(h); or 
(c)  a laboratory which is accredited by UKAS to ISO sta ndard 15189 or ISO/IEC standard 
17025(i), other than a laboratory which processes tests pr ovided by the test provider for 
the purposes of this Schedule or is owned by the test provider or the device manufacturer. 
                                                                                                                                            
(a) 2006 c. 42. 
(b) 1978 c. 29. 
(c) S.I. 1972/1265 (N.I. 14). 
(d) ISO standards are published in Geneva by the Inte rnational Organisation for Standardisation, and are  available on their 
website (www.iso.org) or at ISO Central Secretariat , International Organization for Standardization (I SO), 1 rue de 
Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland. ISO/IEC 17025 General requirements for the competence of 
testing and calibration laboratories was published in November 2017. 
(e) The United Kingdom Accreditation Service is a com pany limited by guarantee incorporated in England a nd Wales under 
number 3076190. 
(f) ILAC is an international organisation which coord inates the work of its signatory national accredita tion bodies which are 
themselves  involved in the accreditation of confor mity assessment bodies, testing laboratories, and m edical testing 
laboratories. 
(g) EA is a regional organisation which coordinates t he work of its signatory national accreditation bodies. EA is recognised by 
and works closely with ILAC.  
(h) A body corporate established under section 232 of  the Health and Social Care Act 2012 (c. 7). 
(i) ISO standards are published in Geneva by the Inte rnational Organisation for Standardisation, and are  available on their 
website (www.iso.org) or at ISO Central Secretariat , International Organization for Standardization (I SO), 1 rue de 
Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland. ISO/IEC 17025 General requirements for the competence of 
testing and calibration laboratories was published in November 2017. ISO 15189 Medical Laboratories re quirements for