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# First Serology Covid Point-of-Care Test Authorized
- URL: https://www.fdaweb.com/first-serology-covid-point-of-care-test-authorized/
- Published: 2020-09-25T12:00:00.000Z
- Updated: 2026-09-14T16:30:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147734

FDA has issued Assure Tech an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for Covid-19\. The Assure Covid-19 IgG/IgM Rapid Test Device was first authorized for emergency use in July and the EUA is now [being reissued](https://www.fda.gov/media/139789/download?ref=fdaweb.com) for the POC use using fingerstick blood samples. “This authorization means that fingerstick blood samples can now be tested in POC settings like doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing,” an [FDA release](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-point-care-antibody-test-covid-19?ref=fdaweb.com) says.

The agency says about 50 serology tests have been granted an EUA since the start of the pandemic. “The Assure test is a lateral flow assay and is authorized for use with venous whole blood, serum, plasma and fingerstick whole blood,” it says. Currently, FDA says it is “unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity, so they should not interpret results from a serology test as telling them they are immune, or have any level of immunity, from the virus. Due to these unknowns, the FDA cautions patients against using the results from these tests, or any serology test, as an indication that they can stop taking steps to protect themselves and others, such as stopping social distancing, discontinuing wearing masks or returning to work.”