- Latest available (Revised)
- Point in Time (15/12/2020)
- Original (As made)
Version Superseded: 15/01/2021
Point in time view as at 15/12/2020. This version of this provision has been superseded.
You are viewing this legislation item as it stood at a particular point in time. A later version of this or provision, including subsequent changes and effects, supersedes this version.
Note the term provision is used to describe a definable element in a piece of legislation that has legislative effect – such as a Part, Chapter or section.
There are currently no known outstanding effects for the The Health Protection (Coronavirus, International Travel) (England) Regulations 2020 (revoked), Paragraph 2.
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
2.—(1) A test is an “appropriate test” where—
(a)it is a test for the detection of coronavirus,
(b)the manufacturer of any device used for the purposes of the test states that the device has—
(i)a sensitivity of at least 97%,
(ii)a specificity of at least 99%, and
(iii)a limit of detection of less than or equal to 1000 SARS-CoV-2 copies per millilitre,
(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,
(iii)is suitable to be used to administer or provide a test to a person of P’s age,
(d)it is not a test provided or administered under the National Health Service Act 2006, the National Health Services (Wales) Act 2006, the National Health Service (Scotland) Act 1978, or the Health and Personal Social Services (Northern Ireland) Order 1972, and
(e)the test provider complies with paragraph 3.
(2) For the purposes of sub-paragraph (1)—
(a)“device” means an in vitro diagnostic medical device within the meaning given in regulation 2(1) of the Medical Devices Regulations 2002,
(b)“sensitivity”, in relation to a device, means how often the device correctly generates a positive result,
(c)“specificity”, in relation to a device, means how often the device correctly generates a negative result,
(d)“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 Secretary of State,
(ii)the National Institute for Health and Care ExcellenceF2, or
(iii)a laboratory which is accredited by the United Kingdom Accreditation ServiceF3 (“UKAS”) to ISO standard 15189 or ISO/IEC standard 17025F4, 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.]
Textual Amendments
F1Sch. 2A inserted (15.12.2020) by The Health Protection (Coronavirus, International Travel) (England) (Amendment) (No. 26) Regulations 2020 (S.I. 2020/1337), regs. 1, 2(7) (as amended by S.I. 2020/1517, regs. 1(3), 5(2))
F2A body corporate established under section 232 of the Health and Social Care Act 2012 (c. 7).
F3The United Kingdom Accreditation Service is a company limited by guarantee incorporated in England and Wales under number 3076190.
F4ISO standards are published in Geneva by the International Organisation for Standardisation, and are available on their website (www.iso.org) or at ISO Central Secretariat, International Organization for Standardization (ISO), 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.
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Point in Time: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Statutory Instrument accessible to readers who are not legally qualified and accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: