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FDA Grants EUAs for PCR Coronavirus Tests, Nasal Swab Self-Collection Kit

NEW YORK — The US Food and Drug Administration this week granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Psomagen, Acupath Laboratories, and BioTNS, as well as a nasal swab self-collection kit from Kroger Health.

Psomagen's Psoma COVID-19 RT Test is designed to detect two regions of the SARS-CoV-2 N gene in upper respiratory and bronchoalveolar lavage specimens. Nucleic acid is isolated and purified using Takara Bio's NucleoSpin RNA Virus kit and the test runs on Roche Molecular Systems' LightCycler 480 instrument.

According to the FDA, the test may only be performed by Psomagen, a Maryland-based subsidiary of South Korea's Macrogen.

The Acupath COVID-19 RT-PCR Assay is designed to detect the SARS-CoV-2 ORF1ab, N, and S genes in nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage specimens. Nucleic acid extraction is performed using Thermo Fisher Scientific's MagMAX Viral/Pathogen Nucleic Acid Isolation Kit and KingFisher Flex Purification System, and the test runs on Thermo Fisher's Applied Biosystems QuantStudio 12k Flex RT-PCR system.

The test may only be performed by Plainview, New York-based Acupath.

BioTNS' COVID-19 RT-PCR Peptide Nucleic Acid kit is designed to detect the SARS-CoV-2 RdRP and N genes in respiratory specimens such as nasal swabs, bronchoalveolar lavage, and nasopharyngeal wash/aspirates or nasal aspirates. The South Korean company's test uses Qiagen's RNeasy Mini Kit for nucleic acid extraction and runs on Bio-Rad's CFX96 Real-Time PCR Detection System or Thermo Fisher's Applied Biosystems 7500 or 7500 Fast RT-PCR systems.

The test may be used by any lab CLIA-certified to perform high-complexity tests, the FDA said.

The Kroger Health COVID-19 Test Home Collection Kit is intended for use by individuals for the self collection of nasal swab specimens at home while video observed by a healthcare provider. Following sample collection, the swab is inserted into a tube with saline and sealed for shipment to a Kroger-designed CLIA-certified lab for analysis.

Kroger Health is the retail healthcare arm of Cincinnati, Ohio-based retail company Kroger.