The US FDA Grants EUA for Quanterix's Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test
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
Ref: Businesswire | Image: Quanterix
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