What if I have a question or need help regarding the test?
Call 1-866-INBIOS1 or 206-344-5821 or submit an online inquiry.
Where can I find information about Emergency Use Authorizations (EUAs) and COVID-19?
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
Is this test FDA approved or cleared?
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 [...]
Where is this test manufactured?
The SCoV-2 Ag Detect™ Rapid Self-Test is manufactured in the USA.
Does this test detect COVID-19 variants?
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 [...]
Can I throw the SCoV-2 Ag Detect™ Rapid Self-Test in the garbage when I’m done testing?
Please recycle the box (it is 100% recyclable), but dispose of the swab, test cassette, and dropper bottle in common household waste.
Can this test be used as proof of a negative COVID test for travel?
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.
Do I have to be vaccinated to use this test?
No. Individuals can utilize this test regardless of vaccination status.
How accurate is this test?
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 [...]