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FDA Grants Emergency Use Authorization for Seasun Biomaterials, Nationwide Children's Hospital Coronavirus Tests

NEW YORK — The US Food and Drug Administration on Monday granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by South Korean diagnostics firm Seasun Biomaterials and Columbus, Ohio-based Nationwide Children's Hospital.

Seasun's U-TOP COVID-19 Detection Kit uses dual-labeled peptide nucleic acid probes to detect two distinct regions in ORF1ab and one region in N gene of the SARS-CoV-2 genome in oropharyngeal and nasopharyngeal swab specimens, anterior nasal and mid-turbinate nasal swabs, nasopharyngeal wash/aspirate or nasal aspirate specimens, and sputum.

The test runs on any authorized RT-PCR instrument and can be performed by any lab CLIA-certified to perform high-complexity tests, according to the FDA.

Nationwide Children's SARS-CoV-2 assay is a modified version of the US Centers for Disease Control and Prevention's 2019-nCoV Real-Time RT-PCR assay, using the same SARS-CoV-2 N1 and N2, and human RNAase P control primers and probes for target amplification and detection. It is designed to detect viral nucleic acid in in upper and lower respiratory specimens including nasopharyngeal swabs, nasal swabs, bronchoalveolar lavage, and sputum.

The laboratory-developed test uses the BioMérieux Nuclisens EasyMag automated nucleic acid extraction system and runs on Thermo Fisher Scientific's Applied Biosystems QuantStudio 7 Flex Real-Time PCR Instrument with QuantStudio Real-Time PCR software v.1.3. It can only be performed at Nationwide Children's CLIA-certified lab.