Thursday, July 22, 2021

US FDA authorises Amazon’s Covid-19 test kit – ET HealthWorld


San Francisco: Ecommerce giant Amazon has received the emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for a Covid-19 test kit made by its subsidiary STS Lab Holdco.

Amazon plans to use the real-time RT-PCR Test for detecting SARS-CoV-2 as part of the company’s overall preparedness and response programme.

Individuals who are permitted to enter Amazon facilities under these health and safety measures will be invited to be tested periodically using the Amazon Test.

The US FDA said in a statement that the “Amazon real-time RT-PCR test for detecting SARS-CoV-2 will be performed at laboratories designated by STS Lab Holdco (a subsidiary of amazon.com)”.

Amazon employees may automatically be provided with a testing appointment. The appointment day and time will be determined by the testing cadence which is typically every 14 days depending on the individual’s work schedule and previous test result.

The test is done using a nasal self swab that can be done either under the supervision of a health care provider or as part of an at-home kit where a patient takes their own sample and mails it to a lab.

The new test is a modification of another Covid-19 test made by BGI Genomics.

“For individuals who are not automatically scheduled for testing, Amazon will communicate information about testing availability, frequency, and other aspects of Amazon’s testing programme through a variety of channels, including regular manager alerts, direct-to-employee notifications, text messages, and signage,” the FDA authorisation read.





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