Amazon’s top priority throughout the COVID-19 pandemic has been the health and safety of our employees and customers. We’ve invested billions in that effort, including building an in-house COVID-19 testing program to ensure front-line employees have access to free, regular testing with state-of-the-art diagnostic laboratories in the U.S. and the UK.
These labs have processed millions of tests from over 750,000 of our front-line employees, making Amazon a leader in employer-driven COVID-19 testing. We learned a lot through that process, and we’re excited to extend this reliable and convenient COVID-19 testing service to our customers through Amazon.com.
The Amazon COVID-19 Test Collection Kit DTC has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Customers can use the test collection kit at home, and the kits are processed by Amazon’s in-house laboratory using a sensitive method known as RT-PCR, which is considered the current “gold standard” diagnostic approach by the U.S. Centers for Disease Control and Prevention.
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“Even as COVID-19 vaccinations continue, widespread access to reliable and affordable COVID-19 testing remains a critical tool in the fight against the spread of the virus,” said Cem Sibay, the Amazon vice president at the helm of the company’s COVID-19 testing work. “The Amazon collection kit offers customers the convenience they’ve come to expect from Amazon.com by providing access to COVID-19 testing whenever and wherever they need it. The test collection kit provides highly accurate and timely results, helping customers feel more confident as they safely return to travel, work, college, and daily life.”
The collection kit is now available to U.S. customers on Amazon.com for $39.99 and does not require a prescription. It is authorized for use by individuals 18 years or older, with or without COVID-19 symptoms. The collection kit includes Amazon Prime delivery at no additional cost. It’s also easy to use and requires a quick sample collection using a gentle, lower nasal swab. The process, including test registration and collection, takes less than 20 minutes to complete.
The collection kit is FSA and HSA eligible and comes with pre-paid next-day return delivery to Amazon’s state-of-the-art diagnostics laboratory in Hebron, Kentucky. Customers will receive test results within 24 hours of their sample arriving at the lab, and results are available through Amazon's secure website AmazonDx.com.
This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
