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emergency use authorization

The test is designed to detect a nucleic acid sequence from the SARS-CoV-2 E gene in various respiratory specimens including nasal swabs.

The company said it has also received Emergency Use Authorization from the US Food and Drug Administration for its nucleic acid extraction kit.

CDC Director Robert Redfield told a congressional subcommittee about the test, for which the center plans to seek Emergency Use Authorization from the FDA.

The test measures levels of interleukin 6, which is an indicator for acute inflammation and can be used to identify COVID-19 patients at high risk of intubation.

The PCR-based tests, which detect regions in the virus' nucleocapsid gene, may only be performed at their developers' CLIA-certified labs.

The FDA has added an at-home self-collection template to its SARS-CoV-2 EUA guidance as more firms seek to develop sampling kits for use in homes.

Of the 28 companies in the index, 21 firms saw their stock prices increase, while seven firms' share price decreased. 

The company said it has production capacity for more than 50 million tests per month and that its high-throughput analyzers can deliver up to 440 tests per hour. 

The lateral flow assay is designed to detect and differentiate immunoglobulin G and immunoglobulin M antibodies against SARS-CoV-2.

The test uses a proprietary at-home PCR nasal swab test with a turnaround time of 24 hours and is authorized for use by at-risk people.

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