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27th October 2021  Product update: rapidvirology staff writer

US FDA Authorize SARS-CoV-2 Neutralizing Antibody ELISA Test

The US FDA has granted the SCoV-2 Detect™ Neutralizing Ab ELISA test emergency use authorization. The test is made by InBios International and is an in vitro diagnostic for the qualitative detection of neutralizing antibodies to SARS-CoV-2 in human serum and plasma (dipotassium EDTA, lithium heparin, and sodium citrate).

The qualitative inhibition ELISA detects antibodies against the SARS-CoV-2 Spike protein (S) and antibodies that prevent the virus's binding to the human angiotensin-converting enzyme 2 (ACE2) receptor.

This test is intended for use as an aid in identifying individuals with an adaptive immune response against the protein domains that interact with SARS-CoV-2 binding to its receptor (ACE2), indicating recent or prior infection.  

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 SARS-CoV-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, or use thereof, is covered, in whole or in part, by one or more patent applications and is patent pending.

Key Features/Performance:

  • FDA Emergency Use Authorized
  • PPA (Sensitivity): 96.2%
  • NPA (Specificity): 96.3%
  • Kit includes 96 well plate and all necessary reagents and controls to perform assay
  • The entire procedure takes ~3 hours
  • Patent Pending (this product, or use thereof, is covered, in whole or in part, by one or more patent applications)

Visit InBios.com to learn more or send a quick inquiry using the 'Request Information' button provided below.



Date Published: 27th October 2021

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Note: This content has been edited by a rapidvirology.com staff writer for style and content.

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