RE: Email sent to Julie Bradshaw - The Telegraph25 Jun 2021 11:00
2/2
Furthermore, despite the Innova test being originally designed for ‘professional use’ (see Innova IFU (4) – “The SARS-CoV-2 Antigen Rapid Qualitative Test is intended for use by trained clinical laboratory personnel”), the DHSC have re-designated the scope of the test as one that can be self-administered (5) (where the person taking the test obtains their own sample - a.k.a. self-use). In another cavalier move, the DHSC have distributed the Innova test for the purpose of identifying asymptomatic individuals, which runs contrary to the following statement in the Innova IFU (4) – “The performance of this test has not been evaluated for use in patients without signs and symptoms of respiratory infection and performance may differ in asymptomatic individuals”.
By appointing themselves ‘judge and jury’ of the Innova test, the DHSC has allowed itself to make fundamental changes to the Innova test’s characteristics, implementing them without any follow up Porton Down assessment; changes that would inevitably have had a significant detrimental impact on the test’s already underwhelming performance. Notably, to date, the government have not seen fit to publicly assess the impact of these wholesale changes.
It can clearly be seen that the initial Porton Down assessment of the Innova test is for all intents and purposes redundant, given the elemental changes made to the test’s characteristics by the DHSC, since that initial assessment was made. To use this redundant Porton Down assessment as evidence of ‘equivalence’ to the newly proposed assessment criteria, can at best be described as fanciful and at worst criminally irresponsible.
In summary, I would kindly request that you table an amendment to the proposed new legislation that either removes this exemption clause entirely, or modifies the wording to a version similar to that shown below:
“Tests currently supplied to the NHS under DHSC procurement will be exempted in recognition of prior equivalent assessment, so long as the prior equivalent assessment used the same sampling method as that for which the test is currently (or, intended to be) purposed and that the test was assessed for self-use purposes.”
I have kept this communication as brief as possible, in order not to distract from it’s main objective, however, I would just add that the Innova test in question is the same test that has recently been described as ‘not fit for purpose’ by the US FDA (7) and a test that the UK Government have so far spent close to £3bn on (8).
Kind regards
Sign In
Follow the stocks
