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Yale New Haven Hospital Clinical Virology Lab Gets FDA EUA for Coronavirus Test

NEW YORK – The US Food and Drug Administration on Tuesday granted Emergency Use Authorization to the Yale New Haven Hospital Clinical Virology Laboratory for its SARS-CoV-2 RT-PCR test.

The assay is a real-time RT-PCR test for the qualitative detection of nucleic acid from the SARS-CoV-2 virus in respiratory specimens collected from individuals suspected of having COVID-19 by a healthcare professional. It uses a TaqMan probe-based chemistry and targets the N1 and N2 nucleocapsid genes of the virus. RNA extraction is performed using the Nuclisens Easymag from BioMérieux and the test runs on the ABI QuantStudio Flex 6 Real-Time PCR System from Thermo Fisher Scientific.

Under the EUA, only the Yale laboratory, a CLIA-certified high-complexity lab, is permitted to conduct the test.

The test was eligible for authorization under the FDA's March 31 EUA for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test). Under that EUA, tests are authorized for use by only the laboratory that developed the test, which must be certified under CLIA to perform high-complexity tests.