Is this test FDA approved or cleared?

By |2022-06-10T23:36:21+00:00May 19th, 2022||

This product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that [...]

Does this test detect COVID-19 variants?

By |2022-08-31T15:28:47+00:00May 19th, 2022||

In a study published in JAMA Network Open, SCoV-2 Ag Detect™ Rapid Self-Test demonstrated similar analytical and clinical performance across 3 phases of circulating SARS-CoV-2 variants (pre-Delta, Delta, and Omicron). Sequence analysis performed at InBios also suggests our test will detect variants currently in circulation. We routinely monitor sequences deposited in GISAID and Nextstrain for emerging [...]

How accurate is this test?

By |2022-05-19T23:03:14+00:00May 19th, 2022|

In a clinical evaluation where results from the SCoV-2 Ag Detect™ Rapid Self-Test were compared to an FDA EUA authorized molecular SARS-CoV-2 test, the SCoV-2 Ag Detect™ Rapid Self-Test correctly identified 85.7% of positive specimens and 100% of negative specimens. The performance of this test is still being studied in patients without signs and symptoms of respiratory infection [...]

Go to Top