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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.

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Antibody testing is expected to play an important role in the management of the COVID-19 pandemic. 


As worldwide COVID-19 cases continue to rise, there is a significant need to increase testing and population surveillance capacity.

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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.