ABHI & BIVDA validation letter raises concerns
The letter raises concerns over validation processes and the quality of some COVID-19 tests available on the market. They argue that implementation of the Coronavirus Test Device Approvals (CTDA) process has damaged the UK diagnostics industry and led to the needless withdrawal of COVID-19 tests with no identified deficiency which has weakened supply resilience in the UK and could disrupt testing capacity and capability.
The letter was shared with David Wells, IBMS Chief Executive and Professor Allan Wilson, IBMS President, as well as politicians and representatives from the diagnostics industry.
David Wells, IBMS Chief Executive said:
"The IBMS welcomes legislation that supports the supply of high-quality diagnostic tests for our patients and the general public.
In enacting this legislation, the Government must ensure that existing capacity and capability is maintained to support the NHS over the coming months. Therefore, industry concerns, together with those of laboratory experts should be taken into consideration, to ensure the supply chain and resilience of the availability of tests is maintained to meet the needs of the country.”