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Written Question
Coronavirus: Screening
Tuesday 30th March 2021

Asked by: Earl Attlee (Conservative - Excepted Hereditary)

Question to the Department of Health and Social Care:

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.

Answered by Lord Bethell

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.

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.


Written Question
Coronavirus: Screening
Tuesday 16th March 2021

Asked by: Earl Attlee (Conservative - Excepted Hereditary)

Question to the Department of Health and Social Care:

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.

Answered by Lord Bethell

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.

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.


Written Question
Coronavirus: Screening
Monday 15th March 2021

Asked by: Earl Attlee (Conservative - Excepted Hereditary)

Question to the Department of Health and Social Care:

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.

Answered by Lord Bethell

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.


Written Question
Coronavirus: Screening
Monday 1st February 2021

Asked by: Earl Attlee (Conservative - Excepted Hereditary)

Question to the Department of Health and Social Care:

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.

Answered by Lord Bethell

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.


Written Question
Coronavirus: Screening
Wednesday 6th January 2021

Asked by: Earl Attlee (Conservative - Excepted Hereditary)

Question to the Department of Health and Social Care:

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.

Answered by Lord Bethell

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.


Written Question
Coronavirus: Screening
Thursday 10th December 2020

Asked by: Earl Attlee (Conservative - Excepted Hereditary)

Question to the Department of Health and Social Care:

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.

Answered by Lord Bethell

The information is not held in the format requested.


Written Question
Coronavirus: Screening
Thursday 10th December 2020

Asked by: Earl Attlee (Conservative - Excepted Hereditary)

Question to the Department of Health and Social Care:

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.

Answered by Lord Bethell

The information is not held in the format requested.