Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether independent laboratory validation of the Randox tests for covid-19 were undertaken by the Government.

Randox laboratory has completed the required standardised process as part of the National Laboratory Validation and Assurance for SARS-CoV-2 (COVID-19) testing.

Test and Trace laboratories must perform a validation exercise which complies with International Organization for Standardization accreditation standards. Validation can be extensive and provides documentary evidence that any assay is suitable for its intended purpose. This may involve experiments to determine its performance characteristics, such as accuracy, sensitivity, limits of detection, reliability and reproducibility.

Any process changes within the end to end testing pathway must be revalidated to demonstrate performance.