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QUOTED. 1 April 2021. US FDA.

Executive Summary

The US FDA says it’s concerned that virus mutations could lead to false results with certain COVID-19 tests and lists tests that it has found are prone to lower sensitivity, based on the agency’s own analysis. See what the agency said about it here.

“Changes in the viral genome can result in changes to viral proteins and, therefore, can also impact the performance of an antigen or serology test.” – US FDA

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