Quanterix Gets Expanded Label on EUA for COVID-19 Antigen Test
Quanterix’s Simoa SARS-CoV-2 N protein antigen test has received an expanded Emergency Use Authorization (EUA) from the FDA to include testing with saliva samples as well as nasal swab samples and for asymptomatic serial testing with nasal swab samples.
The test runs on Quanterix’s Simoa HD-X analyzer. Simoa stands for “single molecule array technology,” a digital approach to immunoassays that allows single molecules to be counted.
The test is validated to detect all “variants of concern” of the coronavirus that causes COVID-19, including the highly transmissible Delta variant, the Billerica, Mass.-based company said.