The US FDA Grants EUA for Quanterix’s Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test

December 31, 2020 Auto Bot Emergency Use Authorization, MedTech, Us FDA 0

Shots:

  • The FDA has issued a EUA for Simoa Semi-Quantitative SARS-CoV-2 IgG Ab test and can be operated on Simoa HD-X Analyzer
  • The test checks for Abs that are directed against the spike protein. The test delivers a numerical result demonstrating Ab concentration ranging from 0.21-250mg/mL. The clinical studies demonstrated that the test had a 100% sensitivity and 99.2% specificity, 15 days or more after a positive PCR test
  • The instrument can be used to measure IgG Abs in patients suspected of prior infection or those who have lately been exposed to SARS-CoV-2

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Quanterix

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