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Home 5 Articles 5 FDA Releases Latest List of Authorized At-Home OTC COVID-19 Tests

FDA Releases Latest List of Authorized At-Home OTC COVID-19 Tests

by | Apr 1, 2022 | Articles, News, Open Content

With coverage of over-the-counter (OTC) COVID-19 tests set to expand to include those covered by Medicare, the U.S. Food and Drug Administration (FDA) recently released its most up-to-date list of authorized at-home test kits for the SARS-CoV-2 virus that causes COVID-19. Medicare will only provide coverage for FDA-authorized OTC test kits. Previously, Medicare only covered COVID-19 tests ordered by a physician or qualified health care provider and performed by a lab. The new rules mean that test kits involving self-collection of samples and reading test results at home that are purchased without a prescription will be covered starting this spring. Such tests are an important way people can quickly and conveniently identify if they have COVID-19, so they can go for further confirmation testing and isolate to help prevent the spread of the virus. Here’s the FDA’s list of authorized at-home OTC COVID-19 diagnostic tests, released March 29, which currently includes 18 different options for consumers: Abbott Diagnostics Scarborough’s BinaxNOW COVID-19 Ag Card Home Test Abbott Diagnostics Scarborough’s BinaxNOW COVID-19 Antigen Self Test Access Bio’s CareStart COVID-19 Antigen Home Test ACON Laboratories’ Flowflex COVID-19 Antigen Home Test Becton, Dickinson and Company’s (BD’s) BD Veritor At-Home COVID-19 Test Celltrion USA’s Celltrion […]

Stock image of Close Up Of Human Hands Holding A Covid Self Test

With coverage of over-the-counter (OTC) COVID-19 tests set to expand to include those covered by Medicare, the U.S. Food and Drug Administration (FDA) recently released its most up-to-date list of authorized at-home test kits for the SARS-CoV-2 virus that causes COVID-19. Medicare will only provide coverage for FDA-authorized OTC test kits. Previously, Medicare only covered COVID-19 tests ordered by a physician or qualified health care provider and performed by a lab.

The new rules mean that test kits involving self-collection of samples and reading test results at home that are purchased without a prescription will be covered starting this spring. Such tests are an important way people can quickly and conveniently identify if they have COVID-19, so they can go for further confirmation testing and isolate to help prevent the spread of the virus.

Here’s the FDA’s list of authorized at-home OTC COVID-19 diagnostic tests, released March 29, which currently includes 18 different options for consumers:

  • Abbott Diagnostics Scarborough’s BinaxNOW COVID-19 Ag Card Home Test
  • Abbott Diagnostics Scarborough’s BinaxNOW COVID-19 Antigen Self Test
  • Access Bio’s CareStart COVID-19 Antigen Home Test
  • ACON Laboratories’ Flowflex COVID-19 Antigen Home Test
  • Becton, Dickinson and Company’s (BD’s) BD Veritor At-Home COVID-19 Test
  • Celltrion USA’s Celltrion DiaTrust COVID-19 Ag Home Test
  • Cue Health’s Cue COVID-19 Test for Home and Over The Counter (OTC) Use
  • Detect’s Detect Covid-19 Test
  • Ellume Limited’s Ellume COVID-19 Home Test
  • iHealth Labs’s iHealth COVID-19 Antigen Rapid Test
  • InBios International’s SCoV-2 Ag Detect Rapid Self-Test
  • Lucira Health’s Lucira CHECK-IT COVID-19 Test Kit
  • Maxim Biomedical’s MaximBio ClearDetect COVID-19 Antigen Home Test
  • OraSure Technologies’ InteliSwab COVID-19 Rapid Test
  • PHASE Scientific International’s INDICAID COVID-19 Rapid Antigen At-Home Test
  • Quidel Corporation’s QuickVue At-Home OTC COVID-19 Test
  • SD Biosensor’s COVID-19 At-Home Test
  • Siemens Healthineer’s CLINITEST Rapid COVID-19 Antigen Self-Test

Further information about the tests can be found on the FDA website.