FDA Greenlights Access Bio’s COVID-19 Antigen Test

Emergency Use Authorization Granted for CareStart Point-Of-Care Kit

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

“This rapid antigen test may be the key to reopening schools and businesses,” said Young H. Choi, chairman and CEO, Access Bio. “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 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,” said Reeve Benaron, Founder, chairman and CEO, Intrivo Diagnostics, the exclusive distributor of the tests, “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 CareStart COVID-19 antigen test is a lateral-flow immunochromatographic assay 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. Clinical validations are showing results of 88.4% sensitivity and 100% specificity. It is the third test from Access Bio to receive EUA authorization from the FDA after its CareStart COVID-19 RT-PCR test and CareStart 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 CareStart 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.

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