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Mass General, CHOP, Northwestern Med Get FDA EUAs for SARS-CoV-2 Tests

NEW YORK – Massachusetts General Hospital, the Infectious Disease Diagnostics Laboratory at Children's Hospital of Philadelphia (CHOP), and the Diagnostic Molecular Laboratory at Northwestern Medicine, have received Emergency Use Authorization from the US Food and Drug Administration for tests to detect SARS-CoV-2.

All three organization's real-time RT-PCR tests were cleared by the FDA last week for detecting  SARS-CoV-2 using nasopharyngeal swabs, nasal swabs, and bronchoalveolar lavage specimens.

The FDA granted EUAs for the three tests under guidance released by the agency on March 31 for molecular-based, laboratory-developed tests for detecting the coronavirus. 

Massachusetts General's MGH SARS-CoV-2 assay can be used with Roche's Cobas Z 480 real-time PCR analyzer, Thermo Fisher Scientific's Applied Biosystems QuantStudio 7 Flex Real-Time PCR system, and Thermo Fisher's ViiA 7 Real-Time PCR system. RNA extraction for the test is done with Qiagen's QIAamp Viral RNA Mini Kit. 

The SARS-CoV-2 RT-PCR Test from CHOP also works with nasopharyngeal and tracheal aspirates and is used with the Roche MagNaPure LC Total Nucleic Acid extraction platform and Thermo Fisher Scientific's Applied Biosystems Quant DX PCR platform. Testing is limited to the hospital's CLIA-certified Infectious Disease Diagnostics Laboratory. 

The Northwestern Medicine SARS-CoV-2 Assay uses reagents, primers, and probes that were developed by the US Centers for Disease Control and Prevention, which received EUA in February. It also works with oropharyngeal swabs and is meant for use with Thermo Fisher Scientific's Applied Biosystems Quant Studio 6 Flex instrument. The assay will be performed in the CLIA-certified Northwestern Diagnostic Molecular Laboratory.