Another SARS-CoV-2 laboratory diagnostic has caught the attention of the Biomedical Advanced Research and Development Authority (BARDA), which is teaming up with OraSure Technology, Inc. to get it United States Food and Drug Administration (FDA) Emergency Use Authorization (EUA).
This test, which utilizes the high-throughput ELISA platform, tests oral fluids for signs of antibodies. No such test currently exists, so the partners hope to see it become readily available at doctors’ offices, clinics, and hospitals. It would allow patients to collect their saliva samples at home and ship their samples to a lab for examination. In this way, it’s non-invasive and reduces the amount of human contact required for testing.
Since samples could be acquired at home, the nature of the test would also allow more patients to be screened quicker.
The test will run on ELISA instruments, such as Hamilton or Dynex. Different versions of the test are also being investigated, with the ability to detect things like human anti-Nucleocapsid protein or human anti-Spike 1 total antibody, granting the potential to screen acute infection among the asymptomatic. Antibodies for both have been seen in COVID-19 patients following the onset of symptoms.
OraSure is confident that the newfound support will result in EUA within five months. If granted, the company would then conduct usability and flex studies before submitting data as an amendment to the EUA.