BIVDA commentary on proposed validation of COVID Antigen tests for sale in the private sector

7th May 2021

After careful consideration, BIVDA believes that setting up a separate validation process sets both an unwarranted precedent for the industry and undermines the regulatory system. Our position is that changes to the existing regulatory regime could achieve what the validation policy is trying to do, more effectively and without creating a two-layer system – a view in which we are aligned with the ABHI.

The policy is further complicated by the validation intending to cover both private testing laboratory services as well as technology designed to be used at point of use such as lateral flow tests. BIVDA believe that as the testing laboratories are already having to go through a separate accreditation process with UKAS, then whatever test they are using will have been verified and validated by their internal procedures as professional scientists and this process will have been scrutinised by UKAS. Therefore, there should not be any need to validate the products used within these laboratories.

We are concerned that non-laboratory tests will be examined by scientists who are not regulators and have not had the training that exists within a regulatory body. Having a ‘UK Approved’ test will still not guarantee the best performance as we know that most errors from lateral flow tests are still caused during use, either by people not understanding the instructions for use or deviating from them.

BIVDA supports the alternative suggestion posed by the ABHI, that adding COVID antigen tests to the scope of the Medical Devices Regulations 2002, be urgently and seriously considered as an alternative to moving forward with the proposed ‘UK Approved’ validation scheme for COVID antigen tests. This ensures that test quality would be scrutinised, each batch would be verified and the post market surveillance system would ensure continual good performance from the manufacturers using the existing regulatory infrastructure.

ENDS

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For more information please contact BIVDA CEO Doris-Ann Williams on doris-ann@bivda.org.uk