Call 1-866-INBIOS1 or 206-344-5821 or submit an online inquiry.
For more information on EUAs, please visit http://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization For the most up-to-date information on COVID-19, please visit cdc.gov/COVID19
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 [...]
Sequence analysis suggests our test will detect variants currently in circulation. We routinely monitor sequences deposited in GISAID and Nextstrain for emerging SARS-CoV-2 mutations and variants and pay special attention to CDC data on circulating rates, and variants defined by the CDC as Variants of Concern (VoC) and Variants of Interest (Vol). Performance at the time [...]
Please recycle the box (it is 100% recyclable), but dispose of the swab, test cassette, and dropper bottle in common household waste.
The SCoV-2 Ag Detect™ Rapid Self-Test does not provide documentation of a test result for this purpose. Please visit the website of your airline for up-to-date information about what is required. The CDC also provides information about requirements for international travel.
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. [...]