The Department of Health and Social Care announced its new national testing strategy, which aimed to scale up testing programs for COVID-19. To reach the aim, the evaluation process of virus detection and antibody detection tests to place the test kit on the market in the UK was initiated. The call for proposals to supply antibody detection tests has been closed, but proposals for virus detection tests are still ongoing.
To be evaluated, the test should meet the Targets Product Profile (TPP) criteria that have been developed to help manufacturers design and deliver tests. If the test meets the TPP, or if the test does not match the specifications of the TPP but looks promising, the proposal should be submitted via the DHSC portal. The DHSC has a set process for the evaluation of diagnostic tests for COVID-19, as well as for multiplex respiratory virus tests. The process of evaluation is possible for CE marked and non-CE-marked tests (with the additional step of applying for a derogation).
Test kit manufacturers are required to make claims about the expected performance of their test kit before they can place the test kit on the market in the UK. The claims include analytical sensitivity, diagnostic sensitivity, analytical specificity, diagnostic specificity, accuracy, repeatability, reproducibility, including control of known relevant interference, limits of detection.
The full details in English can be found here.
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