Rapid Antibody Test

For use in point-of-care settings


Assure COVID-19 Rapid antibody test detects the presense of antibodies to SARS-CoV-2 which may help identify people who may have been infected or have recovered from the COVID-19 infection

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First authorized rapid antibody test for use with fingerstick blood 

Key Benefits

  • Results in 15 minutes
  • High accuracy
  • Easy to use
  • No equipment required
  • Fingerstick specimen, no venapuncture required

About the Rapid Antibody Test

This test is a rapid antibody test which can be used in a point-of-care setting.   It can help assess presence of antibodies to the virus that causes COVID-19. An antibody test may not be able to show if you have a current infection, because it can take 1-3 weeks after infection to make antibodies.   A positive test result may show a recent or prior COVID-19 infection and that the patient has developed an antibody response to the virus.


▪ This test has not been FDA cleared or approved;
▪ This test has been authorized by FDA under an EUA for use by authorized laboratories;
▪ This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
▪ This test 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
▪ Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
▪ This product is intended for professional use and not for home use.
▪ Not for the screening of donated blood.

Only available to medical clinics and pharmacies, not individual customers.

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