RE: Anti-Innova Campaign23 Jun 2021 10:12
Dear [MP NAME] or [Journalist Name]
I am writing to you about the £4bn Innova Contract Scandal - a matter of great concern to anyone who wants to see UK taxpayer money used wisely, the economy opened up as soon as possible and, above all, the spread of Covid 19 stopped.
The rapid lateral flow Covid-19 antigen tests that are the cornerstone of the UK’s mass testing programme 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:
Sensitivity 76.8%, reducing to 57.5% when used by non professionals
(Sensitivity = correctly showing negative results for non-infected people)5 Innova's low sensitivity means that the tests would fail to identify up to half of active cases6.
Specificity 99.68% (Specificity = correctly showing positive result for infected people)
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
Our government claimed it was a top priority to create a world-beating UK diagnostics industry and to procure a sovereign test and supply chain (vital for future pandemic preparedness). However, in bending the rules for Innova, they have not only held up the development and validation of UK-made lateral flow antigen tests of superior quality, they have also failed to settle outstanding bills.
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