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 [...]

What is the difference between an antigen and a molecular test?

By |2022-05-19T23:02:46+00:00May 19th, 2022||

An antigen test, such as the SCoV-2 Ag Detect™ Rapid Self-Test, detects proteins from the virus. Molecular tests detect genetic material from the virus. Antigen tests are very specific for the virus, but not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. [...]

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