SCoV-2 Detect™ Neutralizing Ab ELISA
FDA Emergency Use Authorized and CE Marked
The SCoV-2 Detect™ Neutralizing Ab ELISA is an enzyme-linked immunosorbent assay intended for the qualitative direct detection of total neutralizing antibodies to SARS-CoV-2 in human serum and plasma (dipotassium EDTA, lithium heparin, and sodium citrate). It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
InBios’ qualitative inhibition ELISA detects antibodies reactive to the SARS-CoV-2 Spike protein (S) as well as antibodies that prevent binding of the virus to the human angiotensin-converting enzyme 2 (ACE2) receptor.
At this time, it is unknown for how long antibodies persist following infection and if the presence of neutralizing antibodies confers protective immunity. The SCoV-2 Detect™ Neutralizing Ab ELISA should not be used to diagnose or exclude acute SARSCoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high complexity tests.
- This product has not been FDA cleared or approved but has been authorized by FDA under an EUA for use by authorized laboratories;
- This product has been authorized only for detecting the presence of neutralizing antibodies to SARS-CoV-2, not for any other viruses or pathogens; and
- The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.