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Hackensack University Medical Center, CirrusDx Coronavirus Tests Get FDA Emergency Use Authorization

NEW YORK — The US Food and Drug Administration on Wednesday granted separate Emergency Use Authorization to PCR-based SARS-CoV-2 tests developed by Hackensack University Medical Center and CirrusDx Laboratory.

Hackensack University Medical Center's CDI Enhanced COVID-19 test includes primers and probes to detect one region in the SARS-CoV-2 nucleocapsid (N) gene (N2) and for the universal detection of SARS-like coronaviruses, in nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swabs, as well as nasopharyngeal wash/aspirate or nasal aspirate specimens. It uses Roche Molecular Systems' MagNA Pure 24 extraction system and Bio Molecular Systems' Mic PCR cycler with micPCR software version 2.8.0 or version 2.8.13.

The CirrusDx SARS-CoV-2 assay uses primers and probes to detect the SARS-CoV-2 nucleocapsid gene, envelope gene, and RNA-dependent RNA polymerase gene in nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, and bronchoalveolar lavage specimens. Nucleic acid extraction is performed with either Thermo Fisher Scientific's KingFisher Flex automated system or the Qiagen QIAamp Viral Mini Kit, and the test runs on Thermo Fisher's Applied Biosystems QuantStudio 7or QuantStudio 5 instruments.

According to the FDA, both tests are to be performed in the labs where they were developed.