CVS Pharmacy, the retail division of CVS Health, today announced the availability of three over-the-counter COVID-19 testing options in stores and online.

In a press release today, CVS says that the tests include the Ellume COVID-19 Home Test, the Abbott BinaxNOW COVID-19 Antigen Self Test, and the Pixel by Labcorp PCR Test Home Collection Kit.

All three tests have received FDA Emergency Use Authorization (EUA), do not require a prescription, and are intended for use by individuals with or without symptoms, according to CVS.

“These options provide customers with access to convenient testing that can be conducted at home and complement CVS Health’s commitment to providing consumers with access to comprehensive COVID-19 testing services,” said CVS in the press release.

“Access to testing continues to be an important part of the nation’s pandemic response. Making OTC COVID-19 tests available to our customers helps remove barriers by providing convenient options for testing,” said George Coleman, Senior Vice President and Chief Merchant, CVS Pharmacy in a statement included in a press release. “CVS Health has been a leader in providing accessible testing in communities nationwide, and we continue to bring new solutions to market to ensure that consumers have a variety of COVID-19 testing options available to them.”

The three testing options now available at CVS include:

Ellume COVID-19 Home Test Kit $38.99: The first rapid, fully at-home test to receive Emergency Use Authorization by the FDA for at-home use without a prescription. The test delivers results in 15 minutes through a free app downloaded to a smartphone, without the need for a second test. CVS Pharmacy is the first retailer to carry the Ellume Home Test Kit. It will be in select locations in RI and MA the week of April 19, with increasing availability on CVS.com and in most CVS Pharmacy locations by the end of May.

  • According to CVS: The Ellume COVID-19 Home Test has not been FDA cleared or approved; but has been authorized by the FDA under an emergency use authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and 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.

Abbott BinaxNOW COVID-19 Antigen Self-Test $23.99: Reliable fully at-home test for surveillance and frequent use delivers results in 15 minutes. The box contains two tests which should be administered twice over three days with at least 36 hours between tests. The test is available at CVS.com and in 5,600 CVS Pharmacy locations as the week of April 19, with additional locations to follow.

  • According to CVS: The BinaxNOW COVID-19 Antigen Self Tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization. The tests have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and are 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.

Pixel by Labcorp Home Collection Kit 3: This PCR (polymerase chain reaction) test is the same test used by physicians across the U.S. Results typically are available within 1-2 days and can be accessed via the Pixel by Labcorp website. The test is available now at CVS.com and in select stores in AL, MA, RI and CT.

  • According to CVS: Pixel by Labcorp offers this product with an FDA Emergency Use Authorization (EUA). This means that this product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA. This product has only been authorized by FDA for detection of nucleic acid from SARS-CoV-2 (i.e., the COVID-19 virus), and not for any other virus or pathogen. 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.

CVS says that the OTC testing options are not covered by insurance and are not meant to diagnose acute COVID-19 infection or test the efficacy of COVID-19 vaccination.

CVS Health has been increasing access to testing options since the start of the pandemic and has completed more than 15 million COVID-19 tests to date across more than 4,800 testing sites at select CVS Pharmacy locations, with nearly 1,000 of those locations providing rapid-result testing. With the addition of OTC testing options that can be conducted from the comfort of home, CVS Pharmacy continues to serve as a leader in COVID-19 testing, which remains a critical component of the nation’s pandemic response.

More information about testing services is available at CVS.com.

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Ryan M. Belmore

Ryan M. Belmore is the Owner & Publisher of What's Up Newp. Ryan is a member of Local Independent Online News (LION) Publishers and serves on the Board of Directors for Fort Adams Trust and Lucy's Hearth. Send questions, tips, and story ideas to Ryan@whatsupnewp.com.