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Mount Sinai, Empire City Laboratories SARS-CoV-2 Tests Get FDA Emergency Use Authorizations

NEW YORK — The US Food and Drug Administration this week granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Mount Sinai Hospital and Empire City Laboratories.

The Mount Sinai SARS-CoV-2 Assay is designed to qualitatively detect SARS-CoV-2 nucleic acid in saliva samples self-collected using the Mount Sinai SARS-CoV-2 Collection Kit by individuals 14 years and older, as well as in saliva samples collected by a child 5 years and older with adult assistance.

Samples are returned to the Mount Sinai COVID Laboratory in New York City for testing, according to the FDA.

About a year ago, Mount Sinai received EUA from New York State Department of Health for the quantitative use of its SARS-CoV-2 antibody test.

Empire City Laboratories' ECL COVID Test System and ECL COVID Test System-1 are both designed for the qualitative detection of SARS-CoV-2 nucleic acid from self-collected anterior nasal swab specimens collected at home using the ECL COVID-19 At-Home Collection Kit by individuals 18 years of age and older.

The ECL COVID Test System runs on Roche's Cobas 6800 and 8800 systems. The ECL COVID Test System-1 is a version of the EuroRealTime SARS-CoV-2 assay developed by PerkinElmer subsidiary Euroimmun, which runs on Bio-Rad's CFX96 Touch system.

Both tests are only authorized for use by New York City-based Empire City Laboratories.

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