Confirm Bioscience with regards to it's Orient Gene LFT appears to have distributed it's tests outside the EUA to non certified clinical laboratories: "Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories. 2) COVID-19 Rapid Test Cassettes were not adequately validated for its intended use (fingerstick tests for in-home use/testing)." The QA of the rapid tests in the UK also appear to be a standard exercise: It explains the exercise is a “standard requirement” and part of the “ongoing quality assurance” the government conducts for the NHS Test and Trace schools rapid asymptomatic testing programme.