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MP Caroline Lucas has tabled the question:

To ask the Secretary of State for Health and Social Care, when he plans to answer Question 7785 tabled on 26 May 2021 by the hon. Member for Brighton, Pavilion; and what assessment he has made of the implications for his policies of the US Food and Drug Administration warning, issued on 10 June 2021, for the public to stop using the Innova test; if he will (a) specify how much money has been spent on Innova lateral flow tests to date and (b) estimate how much more will be spent on those tests under current contracts; and if he will make a statement.

Answer:

The Department of Health and Social Care has indicated that it will not be possible to answer this question within the usual time period. An answer is being prepared and will be provided as soon as it is available.

https://questions-statements.parliament.uk/written-questions/detail/2021-06-14/15211

Sources:
1 Expenditure on Innova tests: https://bidstats.uk/tenders/?q=lateral+flow+test
2 NHS rebranding of tests https://www.dailymail.co.uk/news/article-9127345/UK-coronavirus-Department-Health-rebranding-professional-use-kit-self-test.html
3 Gov rewrites test instructions (See question 21) https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/12/C0964-lft-in-primary-care-faqs-v2-jan-2021.pdf
4 MHRA decision overridden https://www.whatdotheyknow.com/request/719170/response/1768848/attach/4/MHRA%20Letter%20DHSC%20COVID%2019%20Self%20Test%2022122020%20Redacted.pdf?cookie_passthrough=1
5 Performance of Innova Tests: https://www.bmj.com/content/371/bmj.m4469
6 Innova test fails to identify cases: https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/12/C0964-lft-in-primary-care-faqs-v2-jan-2021.pdf
7 FDA recall of Innova tests: https://www.bmj.com/content/373/bmj.n1514
8 Heidelberg studies https://www.klinikum.uni-heidelberg.de/en/diagnostics-global-health
9 MHRA extends EUA for Innova tests: https://www.gov.uk/government/news/following-a-satisfactory-review-mhra-extends-authorisation-of-nhs-test-and-trace-lateral-flow-devices
10 Performance of Mologic tests: https://www.finddx.org/wp-content/uploads/2021/06/Mologic_Ag-Public-Report_v1.2-20210615.pdf
11 Performance of Avacta tests: https://avacta.com/wp-content/uploads/2021/06/Brochure-Type-00901-SC2-Product-Specification-Sheet-v2-ID-33989.pdf (See page 2)
12 Mologic to sue Government: https://www.telegraph.co.uk/business/2021/06/14/covid-test-maker-mologic-set-sue-government-stonewalling/
13 Avacta warning regarding Porton Down: (See page 55) https://avacta.com/wp-content/uploads/2021/05/Avacta-ARA-2020.pdf

Questions for Mr Han****:
1) Has the Government spent £4bn of UK taxpayer on a test that has been declared unfit for purpose by America's FDA and of 'High Concern' by Heidelberg Uni research?
2) How could the government justify extending the use of the Innova test when it is potentially failing to discover 40% of infections due to low specificity and not being used as intended
3) How could Govt & MHRA justify switch from Professional use Nasopharyngeal to Home use Anterior Nares with no supporting data?
4) Was it an act of criminal deception that the tests were repackaged with NHS branding and with DHSC assuming the role of 'manufacturer' to override the original instructions for use?
5) Is Porton Down testing with frozen samples fit for purpose, given Mologic & Avacta 'failed' but passed European based field trials with live Covid samples with flying colours?
6) Would you agree that 'Test & Trace' would be far more effective if highly accurate tests, capable of identifying asymptomatic spreaders, were used?

I am writing to alert you to an 'under the radar' scandal regarding the rapid lateral flow Covid-19 antigen tests that are the cornerstone of the UK’s mass testing programme.

The tests are made in China by a company called Xiamen Biotime Biotechnology Co. Ltd, and sold into the UK by a shell company in the USA called Innova Medical Group.

According to Bidstats1, the UK Gov purchased £4,011,000,000 worth of Innova lateral flow tests. A further £230,544,000 was spent to fly them to the UK from China.

Manufacturer, Innova, obtained a CE mark for the tests for professional use on symptomatic individuals and with a swab from the nasopharyngeal area (the painful-to-reach highest part of the nasal passage).

For Test & Trace, DHSC needed a lateral flow test that could be used at home on asymptomatic individuals and wouldn't cause discomfort. Therefore they:
repackaged these tests using NHS branding2,
re-wrote the instructions for use at home by non-professionals, stating that the swab should be taken from the anterior nares (lower nostril) area3
overrode MHRA decision-making processes to pass them for home use in the UK (on both symptomatic and asymptomatic individuals) under an Emergency Use Authorisation4.

In the Liverpool trials, Sir John Bell reviewed the Innova tests with the following results:
Specificity 99.68% (Specificity =correctly showing positive result for infected people)
Sensitivity 76.8%, reducing to 57.5% when used by non professionals (Sensitivity = correctly showing negative results for non-infected people)5 As a result, the tests would fail to identify up to half of active cases6 .

On 10th June, the US Food and Drug Agency (FDA) issued a class 1 recall of Innova tests, warning that the tests should be destroyed and binned or returned to the manufacturer7. Germany's Heidelberg university has collated numerous scientific studies, showing Innova's test to be of 'High Concern'8.On 17th June, the MHRA issued a two month extension to Innova's EUA for the UK9

While bending the rules for Innova, the Government has failed to support the UK based diagnostics industry by holding up the development of lateral flow antigen tests by two UK-based diagnostics companies. Beford-based Mologic Ltd and Whetherby-based Avacta Life Sciences have both developed tests with near-perfect accuracy.

Mologic = Specificity 100%, Sensitivity 96.4%10
Avacta AffiDX = Specificity 99% and Sensitivity 100% 11

Both Mologic and Avacta have needed to have their tests validated in Europe to obtain CE marks. This is because excellent lab-based performance was not being reproduced at Porton Down's approval procedure involves the use of frozen Covid 19 samples (not permitted by the FDA).

As a result, Mologic has taken the step of launching legal proceedings against the Government12 and Avacta has warned its shareholders that Porton Down's procedures may affect the company's chances of winning any UK governmental contract13.

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