RE: Fortress Diagnostics- home use antibody testing28 Jan 2021 08:18
"Thanks regulator.
Wonder why UK-RTC product hasn’t benefited from the same temporary approval to understand the usability?"
I think because they're different types of approvals for different reasons...
The AbC19 test was developed as a professional POC test. It was intended to be either used by a professional or under the supervision of a professional. It wasn't originally intended to be used for 'self-test at home' purposes (I'll use this term as it is what people tend to think of/use).
The government then asked the UK-RTC to trial it as a 'self-test at home' test, as part of the early thinking (such as it was) around Operation Moonshot. However the test had been CE marked at professional POC and wasn't of a class (under the MDD/MDR) that could be CE marked by the manufacturer for 'self use at home'. It would need formal approval from the relevant competent body - the MHRA. Unlike the MHRA EUA, which is only temporary, MHRA approval in this way would be permanent.
The problem is, there were no TPPs or process in place for this. This meant that MHRA had to scrabble round to create and publish these. In the meantime, the UK-RTC undertook further testing (e.g. at the University of Ulster) in anticipation.
However, at the same time, the asperations for Operation Moonshot were being scaled back as it became clear that the UK didn't have the capacity to deliver it - and the costs would be prohibitive. There was a clear shift of focus from antibody testing to antigen testing and, latterly, there were changes in the vaccination processes as the reality of the shakiness of supply chains began to bite. The need for an MHRA approved 'self-test at home' LFT began to recede.
The government has also come under pressure to clean up its act around procurement. It's moving to a more transparent and (from a procurement perspective) recognisable Dynamic Purchasing System framework. That will work in our favour in the long run and I expect to see new UK-developed tests replacing those that are currently being used in the surveillance programmes over the coming weeks and months.