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Re: decentrauthentblock post# 100156

Monday, 05/10/2021 2:13:55 PM

Monday, May 10, 2021 2:13:55 PM

Post# of 104413
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.


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