FDA OK's 10-min COVID-19 Antigen Test

October 13, 2020

Emergency use authorization granted for CareStart point-of-care kit.

The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a COVID-19 CareStart Antigen rapid test under Access Bio, Inc., a New Jersey-based leader in the development and manufacturing of diagnostic tests for infectious diseases.

“This rapid antigen test may be the key to reopening schools and businesses,” says Young H. Choi, chairman and CEO, of Access Bio, in a release. “Within minutes of administering this inexpensive, U.S.-made test, a healthcare provider will better know whether or not a patient is infected.”

Access Bio has an 18-year track record of engineering and manufacturing superior-quality diagnostic kits for malaria, dengue, influenza and other infectious diseases, the release says.

The new rapid antigen test is fast and easy to administer in a point-of-care setting and can be conducted by nasopharyngeal (NP) swab by non-laboratory medical professionals. Access Bio’s rapid antigen test requires no additional equipment or special instrument for sample analyses, and results are visually read onsite in 10 minutes.

“This is a major breakthrough that has the potential to bring our daily lives back to normal,” says Reeve Benaron, founder, chairman and CEO of Intrivo Diagnostics, the exclusive distributor of the tests, in the release. “Because our rapid Antigen test does not require an instrument or machine, this means the test can be used anytime, anywhere. We’re confident that our test is a game-changer because it can be mass produced and is inexpensive enough to be widely used by healthcare professionals in schools, at large gatherings, and in office buildings.”

The new COVID-19 antigen test is a lateral-flow immunochromatographic test for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal specimens collected from individuals suspected of being infected with COVID-19 or exposed to COVID-19, the release says.

Clinical validations are showing results of 88.4% sensitivity and 100% specificity. CareStart is the the third test from Access Bio to receive EUA authorization from the FDA after its CareStart COVID-19 RT-PCR test and CareStartTM COVID-19 IgM/IgG antibody rapid test. Access Bio is now one of only two companies in the world to receive FDA EUA authorization for all available testing products on the market: RT-PCR, antibody, and antigen.

Each CareStartTM COVID-19 antigen test kit includes test devices, assay buffer, extraction vials and caps, specimen collection swabs, positive and negative control swabs, and instructions. Each kit can administer up to 20 antigen tests.

For more information about Access Bio and the CareStartTM COVID-19 Antigen test, visit: https://www.carestartantigen.com.