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Cleveland Clinic, Three Other Labs Get FDA EUAs for Coronavirus Tests

NEW YORK — The US Food and Drug Administration on Monday granted separate Emergency Use Authorizations for SARS-CoV-2 molecular diagnostic tests developed by Ethos Laboratories, Wren Laboratories, the Cleveland Clinic, and Poplar Healthcare.

Ethos' SARS-CoV-2 MALDI-TOF Assay, which uses Agena Bioscience's SARS-CoV-2 Panel Set, is designed to detect the N gene, ORF1 gene, and ORF1ab gene of the virus in upper respiratory and bronchoalveolar lavage specimens collected by healthcare providers. It is also authorized for use with nasal swab specimens that are self-collected using Ethos' U-Collect At Home Collections kit.

The test is the only one so far using mass spec-based technology that has received EUA for SARS-CoV-2 testing.

The RT-PCR/MALDI-TOF mass spectrometry assay uses Thermo Fisher Scientific's KingFisher Flex Purification System and Applied Biosystems Veriti 96 Thermal Cycler, and runs on Agena's MassArray System.

Wren's COVID-19 PCR Test is designed to detect the SARS-CoV-2 N gene using primers and probes developed for the US Centers for Disease Control and Prevention's CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel in nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swabs, as well as nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage specimens.

It uses Eppendorf's Nexus Gradient Mastercycler for cDNA synthesis and runs on Thermo Fisher's Applied Biosystems QuantStudio 7 Flex RT-PCR instrument.

The Cleveland Clinic SARS-CoV-2 Assay is designed to detect the E and RdRP gene of the virus in nasopharyngeal, oropharyngeal, and nasal swab specimens, as well as and bronchoalveolar lavage, tracheal aspirate, and sputum samples.

Nucleic acid extraction is performed using Roche's MagNA Pure 96 instrument and the test runs on Roche's LightCycler 480 and/or Cobas z 480 RT-PCR analyzer.

The Poplar SARS-CoV-2 TMA Pooling assay is a transcription-mediated amplification test performed using Hologic's Aptima SARS-CoV-2 assay, which is designed to detect the virus' ORF1ab gene and runs on the company's Panther molecular diagnostics system.

Poplar's test can be used with pooled samples containing up to seven upper respiratory specimens, including self-collected nasal swabs specimens or clinician-collected nasal, nasopharyngeal, and oropharyngeal swab specimens.

All four SARS-CoV-2 tests may be performed only by their developers, according to the FDA.