HS3822

Covid-19 Detection Test Regulation [proposed title]

We are considering regulation to require the validation of all Covid-19 detection tests for human use made available for private sale. This would set minimum quality standards for specificity and sensitivity against which Covid-19 tests would be assessed. This would prevent retailers from selling tests that haven't been validated to meet this standard and place a requirement on manufacturers to seek validation for their tests. There would potentially be a broad suite of enforcement powers up to and including criminal sanction. The intention would be to place the results of each test's validation in the public domain to inform consumer choice. In scope will be mature antigen detection and molecular detection technologies, as such the  main tests we expect to be assessed are Lateral Flow Tests, and Polymerase chain reaction (PCR) tests. Given the urgency and the set up times we envisage doing this via a single government run process.