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FDA Allows Emergency Use of Applied BioCode, Kaiser Permanente, Emory University Coronavirus Tests

NEW YORK — The US Food and Drug Administration has granted separate Emergency Use Authorizations for SARS-CoV-2 tests from Applied BioCode, Kaiser Permanente, and Emory University.

Applied BioCode's SARS-CoV-2 Assay is designed to detect two conserved regions in the virus' N gene in upper respiratory specimens and bronchoalveolar lavage. Nucleic acids are extracted using BioMérieux's NucliSens EasyMag or Roche's MagNA Pure 96 automated systems and the test runs on Applied Biocode's MDx-3000 instrument. The assay may be performed by any lab CLIA-certified for high-complexity tests.

Kaiser Permanente's KPMAS COVID-19 Test comprises a home collection kit that is designed for the self-collection of a nasal swab sample by the healthcare plan's members. Samples are transported to Kaiser Permanente Mid-Atlantic States' regional laboratory in Rockville, Maryland for analysis with Roche's Cobas SARS-CoV-2 assay, which received Emergency Use Authorization in March.

Emory's SARS-CoV-2 RBD IgG test is an ELISA-based assay designed to detect immunoglobulin G antibodies against the virus in human serum in order to determine a recent or prior infection, according to the FDA. Use of the test is limited to Emory Medical Laboratories.

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