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# Cellex EUA for Covid-19 Antibodies Test
- URL: https://www.fdaweb.com/cellex-eua-for-covid-19-antibodies-test/
- Published: 2020-04-02T12:00:00.000Z
- Updated: 2026-09-14T16:09:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146486

FDA has granted an emergency use authorization to Cellex for a coronavirus serology test. The assay is intended for use in CLIA-certified laboratories for detecting Covid-19 antibodies in blood samples. The test could help detect those who have previously been infected and had few, if any, symptoms.  
  
"Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19," the agency said in a [letter](https://www.fda.gov/media/136622/download?ref=fdaweb.com) to the company. The agency said that the antibodies against coronavirus are “generally detectable in blood several days after initial infection,” but it cautioned that “levels over the course of infection are not well characterized.”