Thank you for all the serology (antibody) new test offers that have been submitted to date – these have been greatly appreciated in the efforts to scale up the Government COVID 19 testing programme.

Now that our antibody testing programme is up and running and is meeting our current antibody testing needs, the review and triage of new serology technologies undertaken by the New Tests Advisory Group (NTAG) is no longer accepting new serology or antibody tests. The NTAG will no longer be part of the process for securing derogations from the Medicines & Healthcare products Regulatory Agency (MHRA) and the standard regulatory processes for medical tests overseen by the MHRA will apply to all serology and antibody tests. More details can be found at; https://www.gov.uk/government/publications/in-vitro-diagnostic-medical-devices-guidance-on-legislation.

NHS Trusts interested in using serology or antibody tests are responsible for their own procurement decisions in relation to their choice of commercial test kit.

If this position changes, the website will be updated accordingly.

As part of our commitment to acquiring high-quality products for our national COVID-19 testing programme, we have introduced additional due diligence checks. As a result, we are only able to accept offers for viral detection tests directly from the product developer (test manufacturer). This ensures that the associated scientific group can confirm technical information directly with the producer of the test. Therefore, please ensure that this form is completed directly by the product developer/manufacturer rather than a distribution agent. Thank you for your understanding.

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