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NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for a SARS-CoV-2 test developed by Boston Heart Diagnostics (BHD).

The Boston Heart COVID-19 RT-PCR Test is designed to detect the SARS-CoV-2 ORF1ab, S, and N genes in upper respiratory specimens, nasopharyngeal aspirate, and bronchoalveolar lavage specimens. Nucleic acid extraction is performed using Thermo Fisher Scientific's MagMax Viral/Pathogen Nucleic Acid Isolation Kit, and the test runs on Thermo Fisher's QuantStudio 12K Flex Real-Time PCR System.

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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.