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FDA authorizes Cue Health’s OTC COVID-19 test

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The Cue Home and OTC test detects the RNA of SARS-CoV-2. The test is run using the Cue cartridge reader, Cue COVID-19 test cartridge, and Cue sample wand; results are provided via the Cue Health App, on the user’s mobile smart device. In prospective studies to evaluate the use of the Cue OTC Test, results were 97.4 percent agreement for positive cases and 99.1 percent agreement for negative cases compared with results from a highly sensitive EUA PCR laboratory-based test, the company said.

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