- Latest available (Revised)
- Point in Time (20/02/2021)
- Original (As made)
Version Superseded: 23/04/2021
Point in time view as at 20/02/2021. This version of this provision has been superseded.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—
[F2(i)a sensitivity greater than 95% (with 95% two-sided confidence interval entirely above 90%);]
[F3(ii)a specificity greater than 95% (with 95% two-sided confidence interval entirely above 90%);] F4...
(iii)a limit of detection of less than or equal to 1000 SARS-CoV-2 copies per millilitre, [F5and]
[F6(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,
F7(iii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(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)—
F8(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F9(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F10(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(d)“validated”, in relation to a device, means confirmed as having [F11the 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—
(i)the Secretary of State,
(ii)the National Institute for Health and Care ExcellenceF12, or
(iii)a laboratory which is accredited by the United Kingdom Accreditation ServiceF13 (“UKAS”) to ISO standard 15189 or ISO/IEC standard 17025F14, 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 [F15or the device manufacturer].]
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))
F2Sch. 2A para. 2(1)(b)(i) substituted (15.2.2021 at 4.00 a.m.) by The Health Protection (Coronavirus, International Travel) (England) (Amendment) (No. 7) Regulations 2021 (S.I. 2021/150), regs. 1(1), 18(c) (with reg. 23)
F3Sch. 2A para. 2(1)(b)(ii) substituted (15.2.2021 at 4.00 a.m.) by The Health Protection (Coronavirus, International Travel) (England) (Amendment) (No. 7) Regulations 2021 (S.I. 2021/150), regs. 1(1), 18(d) (with reg. 23)
F4Word in Sch. 2A para. 2(1)(b)(ii) omitted (15.2.2021 at 4.00 a.m.) by virtue of The Health Protection (Coronavirus, International Travel) (England) (Amendment) (No. 7) Regulations 2021 (S.I. 2021/150), regs. 1(1), 18(e)(i) (with reg. 23)
F5Word in Sch. 2A para. 2(1)(b)(iii) inserted (15.2.2021 at 4.00 a.m.) by The Health Protection (Coronavirus, International Travel) (England) (Amendment) (No. 7) Regulations 2021 (S.I. 2021/150), regs. 1(1), 18(e)(ii) (with reg. 23)
F6Sch. 2A para. 2(1)(b)(iv) inserted (15.2.2021 at 4.00 a.m.) by The Health Protection (Coronavirus, International Travel) (England) (Amendment) (No. 7) Regulations 2021 (S.I. 2021/150), regs. 1(1), 18(e)(iii) (with reg. 23)
F7Sch. 2A para. 2(1)(c)(iii) omitted (15.2.2021 at 4.00 a.m.) by virtue of The Health Protection (Coronavirus, International Travel) (England) (Amendment) (No. 7) Regulations 2021 (S.I. 2021/150), regs. 1(1), 18(e)(iv) (with reg. 23)
F8Sch. 2A para. 2(2)(a) omitted (15.1.2021 at 4.00 a.m.) by virtue of The Health Protection (Coronavirus, Pre-Departure Testing and Operator Liability) (England) (Amendment) Regulations 2021 (S.I. 2021/38), regs. 1(2), 3(7)(b) (with reg. 4)
F9Sch. 2A para. 2(2)(b) omitted (15.1.2021 at 4.00 a.m.) by virtue of The Health Protection (Coronavirus, Pre-Departure Testing and Operator Liability) (England) (Amendment) Regulations 2021 (S.I. 2021/38), regs. 1(2), 3(7)(b) (with reg. 4)
F10Sch. 2A para. 2(2)(c) omitted (15.1.2021 at 4.00 a.m.) by virtue of The Health Protection (Coronavirus, Pre-Departure Testing and Operator Liability) (England) (Amendment) Regulations 2021 (S.I. 2021/38), regs. 1(2), 3(7)(b) (with reg. 4)
F11Words in Sch. 2A para. 2(2)(d) substituted (15.2.2021 at 4.00 a.m.) by The Health Protection (Coronavirus, International Travel) (England) (Amendment) (No. 7) Regulations 2021 (S.I. 2021/150), regs. 1(1), 18(e)(v) (with reg. 23)
F12A body corporate established under section 232 of the Health and Social Care Act 2012 (c. 7).
F13The United Kingdom Accreditation Service is a company limited by guarantee incorporated in England and Wales under number 3076190.
F14ISO 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.
F15Words in Sch. 2A para. 2(2)(d)(iii) inserted (15.2.2021 at 4.00 a.m.) by The Health Protection (Coronavirus, International Travel) (England) (Amendment) (No. 7) Regulations 2021 (S.I. 2021/150), regs. 1(1), 18(e)(vi) (with reg. 23)
The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
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: