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FDA Issues Emergency Use Authorization for University of Nebraska Medical Center Coronavirus Test

NEW YORK — The US Food and Drug Administration on Thursday granted Emergency Use Authorization for the University of Nebraska Medical Center's PCR-based test for SARS-CoV-2.

The NEcov19 RT-PCR Assay is designed to detect a nucleic acid sequence from the SARS-CoV-2 E gene in nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate swabs, as well as nasal washes, nasal aspirates, and bronchoalveolar lavage specimens.

Automated nucleic acid extraction is performed using either Roche's MagNA Pure Compact instrument or Thermo Fisher Scientific's KingFisher Flex platform. Manual nucleic acid extract can be performed using Qiagen's QiaAmp DSP Viral RNA Mini Kit. The test runs on Thermo Fisher's Applied Biosystems QuantStudio Dx with QuantStudio test development software version 1.0.3.

According to the FDA, the test may only be performed at Nebraska Medicine, the University of Nebraska Medical Center's teaching hospital.