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1257435

	registered interest
	date	01/12/2020
	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	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government what formal quality assurance assessment, or similar, is required to be undertaken before an organisation can be accredited (1) to perform, and (2) to analyse, COVID-19 tests; and what is the minimum standard those organisations must meet before accreditation.
	tabling member printed	Earl Attlee
	type	WrittenParliamentaryQuestion
	uin	HL10945
	answer	answer is ministerial correction date of answer 06/01/2021 answer text <p>All manufacturers of polymerase chain reaction tests for COVID-19 must meet the requirements of our validation process to ensure the accuracy of their tests. The accreditation process for organisations completing COVID-19 testing will be completed by the United Kingdom Accreditation Service and published online.</p> answering member printed Lord Bethell question first answered 06/01/2021 13:44:32 answering member 4708 label Biography information for Lord Bethell
	tabling member	3425 label Biography information for Earl Attlee

1256441

	registered interest
	date	30/11/2020
	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	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government whether they, or their agencies, regularly determine the operational false positive rates for polymerase chain reaction tests carried out at each laboratory undertaking analysis for mass COVID-19 testing; whether they use an ‘end to end’ method to audit those rates; if not, what methodology they use to make such determinations; and whether those methods include inserting samples into the system that cannot be positive.
	tabling member printed	Earl Attlee
	type	WrittenParliamentaryQuestion
	uin	HL10846
	answer	answer is ministerial correction date of answer 15/03/2021 answer text <p>Currently samples are not placed into the system to test operational sensitivity. The Department has undertaken substantial work with Porton Down and the Milton Keynes Lighthouse Laboratory to conduct temperature and long-term stability experiments on sample collection kits to ensure swabs meet an appropriate standard for testing.</p> answering member printed Lord Bethell question first answered 15/03/2021 16:53:54 answering member 4708 label Biography information for Lord Bethell
	tabling member	3425 label Biography information for Earl Attlee

1271072

	registered interest
	date	14/12/2020
	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	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government, further to the Written Answers by Lord Bethell on 10 December (HL10847 and HL10848), why the information sought is not held in the format requested; whether, and if so, (1) how, and (2) where, that information is held; whether they collect any data on the operational false positive rate for polymerase chain reaction COVID-19 tests; if so, which data; what plans they have to publish those data; and what quality assurance checks they undertake on their answers to parliamentary questions.
	tabling member printed	Earl Attlee
	type	WrittenParliamentaryQuestion
	uin	HL11387
	answer	answer is ministerial correction date of answer 30/03/2021 answer text <p>Information regarding the assessment of false negatives is not held in the format requested due to the challenges in estimating clinical sensitivity. We do not collect data on the operational false positive rate.</p><p>All Written Questions receive several stages of quality assurance to ensure that responses are accurate. All answers are drafted by subject matter experts and assured by a senior civil servant with the appropriate knowledge to certify the accuracy.</p> answering member printed Lord Bethell question first answered 30/03/2021 10:48:07 answering member 4708 label Biography information for Lord Bethell
	tabling member	3425 label Biography information for Earl Attlee

1271070

	registered interest
	date	14/12/2020
	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	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government, further to the Written Answer by Lord Bethell on 10 December (HL10847), whether they will now answer the question put, namely, whether the operational false positive rate for polymerase chain reaction COVID-19 tests is regularly determined by inserting samples into the system that cannot be positive; and what is the false positive rate for such samples.
	tabling member printed	Earl Attlee
	type	WrittenParliamentaryQuestion
	uin	HL11386
	answer	answer is ministerial correction date of answer 16/03/2021 answer text <p>Information regarding the assessment of false positives was not held in the format requested due to the challenges in estimating clinical sensitivity. This is part due to a lack of a generally accepted reference standard to compare reverse transcription polymerase chain reaction results. <br> <br> Currently samples are not placed into the system to test operational sensitivity. The Department has undertaken substantial work with Porton Down and the Milton Keynes Lighthouse Laboratory to conduct temperature and long-term stability experiments on sample collection kits to ensure swabs meet an appropriate standard for testing.</p> answering member printed Lord Bethell question first answered 16/03/2021 17:02:43 answering member 4708 label Biography information for Lord Bethell
	tabling member	3425 label Biography information for Earl Attlee

1271069

	registered interest
	date	14/12/2020
	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	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government, further to the Written Answer by Lord Bethell on 10 December (HL10848), what steps they have taken reliably to determine the operational false positive rate for polymerase chain reaction COVID-19 mass testing; and how they have made any such determination.
	tabling member printed	Earl Attlee
	type	WrittenParliamentaryQuestion
	uin	HL11385
	answer	answer is ministerial correction date of answer 01/02/2021 answer text <p>Polymerase chain reaction tests are very specific and the risk of false positives where the test is reacting to other viruses is extremely low. Independent confirmatory testing of positive samples indicates a test specificity that exceeds 99.3%, or a false positive rate of 1%, and additional guidance has been provided to laboratories to reduce the rate even further.</p> answering member printed Lord Bethell question first answered 01/02/2021 12:33:47 answering member 4708 label Biography information for Lord Bethell
	tabling member	3425 label Biography information for Earl Attlee

1256442

	registered interest
	date	30/11/2020
	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	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government whether the operational false positive rate for polymerase chain reaction COVID-19 tests is regularly determined by inserting samples into the system that cannot be positive; and what is the false positive rate for such samples.
	tabling member printed	Earl Attlee
	type	WrittenParliamentaryQuestion
	uin	HL10847
	answer	answer is ministerial correction date of answer 10/12/2020 answer text <p>The information is not held in the format requested.</p> answering member printed Lord Bethell question first answered 10/12/2020 14:29:00 answering member 4708 label Biography information for Lord Bethell
	tabling member	3425 label Biography information for Earl Attlee

1256443

	registered interest
	date	30/11/2020
	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	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government what was the operational false positive rate for polymerase chain reaction COVID-19 tests in each of the last four weeks; and how this rate was determined.
	tabling member printed	Earl Attlee
	type	WrittenParliamentaryQuestion
	uin	HL10848
	answer	answer is ministerial correction date of answer 10/12/2020 answer text <p>The information is not held in the format requested.</p> answering member printed Lord Bethell question first answered 10/12/2020 14:29:53 answering member 4708 label Biography information for Lord Bethell
	tabling member	3425 label Biography information for Earl Attlee