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1567264

registered interest
date	16/01/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Coronavirus: Screening
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, whether covid-19 lateral flow tests issued by (a) the NHS and (b) pharmacies are able to detect current and emergent variants of covid-19.
tabling member constituency	Sefton Central
tabling member printed	Bill Esterson
uin	123919
answer	answer is ministerial correction date of answer 20/01/2023 answer text <p>The performance of the lateral flow devices used in the National Health Service (NHS) are continually monitored and are subject to further evaluation at Porton Down to ascertain that they are able to detect new COVID-19 variants that may emerge into circulation in the United Kingdom.</p><p> </p><p>Tests sold by pharmacies need to be approved under the Coronavirus Test Devices Approval (CTDA) regulations. As part of the post market surveillance, manufacturers of CTDA approved tests need to provide data to the Medicines and Healthcare products Regulatory Agency showing that performance levels are maintained against new COVID-19 variants that may emerge into circulation in the UK.</p><p> </p><p>Both the evaluation conducted at Porton Down and CTDA maintain a highly rigorous testing process and ensure that COVID-19 tests used in the NHS and sold by pharmacies meet strict quality standards. UK consumers can be confident in the tests available, which is vital for managing COVID-19.</p> answering member constituency Lewes answering member printed Maria Caulfield question first answered 20/01/2023 14:30:23 answering member 4492 label Biography information for Maria Caulfield previous answer version 48623 answering member constituency Lewes answering member printed Maria Caulfield answering member 4492 label Biography information for Maria Caulfield
tabling member	4061 label Biography information for Bill Esterson

1418749

registered interest
date	01/02/2022
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Coronavirus: Screening
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 6 January 2022 to Question 98916 on Coronavirus: Screening, which body is responsible for the accreditation of businesses to supply covid-19 lateral flow tests to the NHS.
tabling member constituency	Sefton Central
tabling member printed	Bill Esterson
uin	115890
answer	answer is ministerial correction date of answer 21/04/2022 answer text <p>There is no accreditation process which applies to the businesses supplying COVID-9 lateral flow device (LFD) tests to the National Health Service. However, COVID-19 tests must have either a CE-mark or UKCA mark and either approved under the Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 or listed on one of the temporary protocols. Where the UK Health Security Agency (UKHSA) or the devolved administrations procure LFD tests on behalf of the NHS, Coronavirus Test Device Approval is not required. However, the UKHSA evaluates these tests in a laboratory to ensure they display performance characteristics desirable for population testing. This evaluation is performed in advance of any procurement.</p> answering member constituency Erewash answering member printed Maggie Throup question first answered 21/04/2022 14:40:52 answering member 4447 label Biography information for Maggie Throup previous answer version 49113 answering member constituency Erewash answering member printed Maggie Throup answering member 4447 label Biography information for Maggie Throup
tabling member	4061 label Biography information for Bill Esterson

1400466

registered interest
date	06/01/2022
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Coronavirus: Screening
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, which businesses have been (a) accredited to supply lateral flow tests to the NHS and (b) accredited to supply those tests for use in the UK.
tabling member constituency	Sefton Central
tabling member printed	Bill Esterson
uin	98916
answer	answer is ministerial correction date of answer 01/02/2022 answer text <p>The UK Health Security Agency (UKHSA) does not accredit businesses to supply lateral flow tests. The UK Health Security Agency evaluates lateral flow tests. Only lateral flow tests that pass evaluation are supplied to the National Health Service and are available to be sold in the United Kingdom.</p> answering member constituency Erewash answering member printed Maggie Throup question first answered 01/02/2022 12:24:00 answering member 4447 label Biography information for Maggie Throup previous answer version 42468 answering member constituency Erewash answering member printed Maggie Throup answering member 4447 label Biography information for Maggie Throup
tabling member	4061 label Biography information for Bill Esterson

1400467

registered interest
date	06/01/2022
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Coronavirus: Screening
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, which businesses are awaiting approval from the Medicines and Healthcare products Regulatory Agency to (a) supply lateral flow tests to the NHS and (b) for the use of those tests in the UK.
tabling member constituency	Sefton Central
tabling member printed	Bill Esterson
uin	98917
answer	answer is ministerial correction date of answer 11/01/2022 answer text <p>The Medicines and Healthcare products Regulatory Agency (MHRA) does not approve COVID-19 testing devices. Tests for professional use are subject to self-assessment by the manufacturer before they may be placed on the market. Self-test devices are required to be assessed for conformity to the regulations by an Approved or Notified Body. In addition, tests must also meet the COVID Testing Devices Authorisation requirements.</p><p>In exceptional circumstances, the MHRA can issue an Exceptional Use Authorisation (EUA). The MHRA publishes the names of tests and other medical devices which have been granted an EUA online. The MHRA does not currently have any outstanding decisions for EUAs.</p> answering member constituency Erewash answering member printed Maggie Throup question first answered 11/01/2022 17:43:32 answering member 4447 label Biography information for Maggie Throup
tabling member	4061 label Biography information for Bill Esterson

1293713

registered interest
date	01/03/2021
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Coronavirus: Screening
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, how many days it takes to identify new cases of the P1 Brazilian variant of covid-19 using genomic sequencing
tabling member constituency	Sefton Central
tabling member printed	Bill Esterson
uin	160643
answer	answer is ministerial correction date of answer 05/03/2021 answer text <p>On average, to report the variant profile for a person from taking a test to a confirmed specific variant positive result takes approximately ten days. NHS Test and Trace have established higher priority rapid processes for testing individuals who within the national surveillance programme are suspected to be at higher risk of being P1 variant positive. These higher priority channels can reduce the overall time by one to two days.</p> answering member constituency Faversham and Mid Kent answering member printed Helen Whately question first answered 05/03/2021 09:14:24 answering member 4527 label Biography information for Helen Whately previous answer version 87421 answering member constituency Faversham and Mid Kent answering member printed Helen Whately answering member 4527 label Biography information for Helen Whately
tabling member	4061 label Biography information for Bill Esterson

1249324

registered interest
date	05/11/2020
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Coronavirus: Screening
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, with reference to the OptiGene Direct RT-LAMP test, if he will publish the (a) clinical validity data and (b) results of the Southampton University trial of May 2020.
tabling member constituency	Sefton Central
tabling member printed	Bill Esterson
uin	112037
answer	answer is ministerial correction date of answer 08/01/2021 answer text <p>The Test and Trace Scientific Team are currently preparing a report covering the clinical validation of Optigene’s DIRECT RT-LAMP Test which will incorporate the findings of the pilot carried out in Southampton as well as those from other pilot sites. This report will be published on GOV.UK alongside the report on lateral flow test validation data published on 11 November.</p> answering member constituency Faversham and Mid Kent answering member printed Helen Whately question first answered 08/01/2021 17:19:03 answering member 4527 label Biography information for Helen Whately previous answer version 60405 answering member constituency Charnwood answering member printed Edward Argar answering member 4362
tabling member	4061 label Biography information for Bill Esterson

1248955

registered interest
date	04/11/2020
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Coronavirus: Screening
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, how many of the additional covid-19 tests announced last week were offered through OctiGene.
tabling member constituency	Sefton Central
tabling member printed	Bill Esterson
uin	111492
answer	answer is ministerial correction date of answer 04/12/2020 answer text <p>We do not publish the data in the format requested.</p> answering member constituency Faversham and Mid Kent answering member printed Helen Whately question first answered 04/12/2020 12:33:51 answering member 4527 label Biography information for Helen Whately previous answer version 60001 answering member constituency Faversham and Mid Kent answering member printed Helen Whately answering member 4527 label Biography information for Helen Whately
tabling member	4061 label Biography information for Bill Esterson