Amazon lands EUA for COVID-19 test with home sample collection

According to FDA documents, the test is intended to help stop the spread of COVID-19 among Amazon employees.
By Laura Lovett
03:19 pm
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Amazon Headquarters

(Photo by Sundry Photography/Getty Images)

On Thursday, Amazon landed an FDA Emergency Use Authorization for its COVID-19 test kit with at-home sample collection.

According to FDA documents, the product is cleared for self-sample collection by nasal swab for individuals aged 18 years and over. The kit can be used either under the supervision of a healthcare provider or unsupervised at home. The kit includes a nasal swab, a collection tube, a biohazard bag, and instructions for collection and drop-off. The samples are designated to be tested at Amazon subsidiary STS Lab Holdco.

The new technology will fit into Amazon's employee screening program, according to FDA documents.

"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. To implement the testing program, Amazon has partnered with a third-party healthcare provider who will issue the necessary prescriptions and individual test orders, as well as facilitate the reporting of results to test recipients," the document reads.

Amazon employees will automatically be given testing appointments about every two weeks, which are voluntary. The tests all require an electronic prescription from a provider.

WHY IT MATTERS

In October, Amazon reported that close to 20,000 employees tested positive or presumed positive for the COVID-19 virus.

The company has since bolstered onsite COVID-19 testing for employees and is starting on-site vaccinations for front-line employees. This appears to be one more tool in their collection for preventing the coronavirus spread.

THE LARGER TREND

COVID-19 test kits with at-home sample collection have been coming onto the market. In April, Lab Corp became the first coronavirus test authorized for home sample collection.

Among the more noteworthy authorizations to follow were Lucira's prescription at-home molecular test platform (authorized in November), Ellume Health's app-connected OTC antigen test (authorized in December), and a molecular diagnostic test that does not require a prescription and can be used at home (authorized earlier this month).

At-home sample collection kits had a rocky road at the beginning of the coronavirus pandemic. In early March of 2020, a few companies announced home sample collection services for molecular testing. However, these companies were forced to stop operations after the FDA clarified its policy and warned consumers that these tests weren't authorized.

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