Product Information
  • Product Code: RCPM-00271
  • Quantity: 2 Tests/ Kit
  • Sample: Nasopharyngeal Swab Specimens
  • Format: Cassette
  • Storage Condition: 34-86°F/1-30°C
  • 2 Test Devices
  • 2 Extraction Vials and Caps
  • 2 Nasal Swabs
  • Quick Reference Instructions
  • Fact Sheet for Individuals

Reference Number: RCPM-00271

The CareStart™ COVID-19 Antigen Home Test is a rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal swab samples from individuals aged 2 years or older.

  • A fast and easy method for self-testing anywhere
  • Results are easy to interpret both visually and using the mobile app (details below)
  • Used to qualitatively detect the SARS-CoV-2 nucleocapsid protein and identify an individual’s current COVID-19 infection status
  • Self-collected anterior nasal swab samples
  • Results in just 10 minutes

This test is compatible with the On/Go™ Mobile Application which assists users in visual results interpretation. The app can be accessed with internet connection from the App Store or Google Play Store.

Clinical Performance: Anterior Nasal
Product Documentation
Safety Information
  • For in vitro diagnostic use only.
  • This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA;
  • This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and,
  • 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. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

For information on the EUA, IFU, and purchase orders please contact your local sales representative or contact us at or 1-888-506-2658.

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