NEW YORK — The US Food and Drug Administration this week granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests from Centogene, Aeon Global Health, Akron Children's Hospital, and National Jewish Health.
Centogene's CentoSure-SARS-CoV-2 RT-PCR Assay is designed to detect two regions of the virus' N gene in dry oropharyngeal swab specimens. It runs in a multiplex format that detects all of its targets with different fluorophores.
The test uses Thermo Fisher Scientific's KingFisher Flex instrument for RNA extraction and runs on Roche's LightCycler 480 II PCR system. It may be used by any lab CLIA-certified to perform high-complexity tests, the FDA authorization said.
The Aeon Global Health SARS-CoV-2 Assay is designed to detect the virus' N, S, and ORF1ab genes in nasal, midturbinate, nasopharyngeal, and oropharyngeal swab specimens, as well as nasopharyngeal wash/aspirate or nasal aspirate and bronchoalveolar lavage. The test uses primers and probes validated under the EUA for Thermo Fisher's TaqPath COVID-19 Combo Kit.
Aeon's test uses Thermo Fisher's MagMax Express-96 Magnetic Particle Processor with Omega Bio-Tek's Mag-Bind Viral DNA/RNA 96 Kit for RNA extraction and runs on Thermo Fisher's Applied Biosystems QuantStudio 12K Flex Real-Time PCR System. The test may only be performed by Gainesville, Georgia-based Aeon, according to the FDA.
The Akron Children’s Hospital SARS-CoV-2 Assay is designed to detect the S and E genes of the virus in nasopharyngeal, oropharyngeal, anterior nasal, and midturbinate nasal swabs, as well as nasal aspirates, nasal washes, and bronchoalveolar lavage fluid specimens.
Nucleic acid extraction is performed using Promega's Maxwell 16 MDx and Maxwell 16 Viral Total Nucleic Acid Purification Kit or its Maxwell RSC 48 System and Maxwell RSC Viral Total Nucleic Acid Purification Kit. The test runs on Qiagen's Rotor-Gene Q MDx instrument.
Use of the test is limited to the Akron Children's Hospital Molecular Diagnostic Laboratory in Akron, Ohio, the FDA said in its authorization.
The National Jewish Health Advanced Diagnostics Laboratory's SARS-CoV-2 MassArray Test is designed to detect the N, ORF1, and ORF1ab genes of the virus in upper respiratory and bronchoalveolar lavage specimens.
The test uses the Agena SARS-CoV-2 Panel Set for RNA amplification and detection. Nucleic acid is extracted using Thermo Fisher's MagMax Viral/Pathogen Nucleic Acid Isolation kit on the KingFisher Flex Purification System or the Mag-Bind Viral DNA/RNA kit. It uses Thermo Fisher's Veriti 96 Thermal Cycler for amplification and Agena's MassArray mass spectrometer for detection.
The test may only be performed by National Jewish Health's Advanced Diagnostics Laboratory in Denver, Colorado, according to the FDA.