FDA authorizes first over-the-counter molecular test for at home use

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FDA authorizes first over-the-counter molecular test for at home use
tjordan_drupal
Mar 8, 2021

The Food and Drug Administration Friday authorized the first molecular test to detect the SARS-CoV-2 virus in a nasal swab at home without a prescription. Cue Health expects by summer to daily produce more than 100,000 of the tests, authorized for use in patients age 2 and older.

The test has identified 96% of positive samples from people with symptoms and 100% of positive samples from people without symptoms. It includes a single-use test cartridge and nasal swab, reusable cartridge reader and mobile app, which in the future will allow users to report test results to public health authorities to monitor disease prevalence, FDA said.

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FDA authorizes first over-the-counter molecular test for at home use
tjordan_drupal
Mar 8, 2021

The Food and Drug Administration Friday authorized the first molecular test to detect the SARS-CoV-2 virus in a nasal swab at home without a prescription. Cue Health expects by summer to daily produce more than 100,000 of the tests, authorized for use in patients age 2 and older.

The test has identified 96% of positive samples from people with symptoms and 100% of positive samples from people without symptoms. It includes a single-use test cartridge and nasal swab, reusable cartridge reader and mobile app, which in the future will allow users to report test results to public health authorities to monitor disease prevalence, FDA said.

Novel Coronavirus (SARS-CoV-2/COVID-19)
COVID-19: CDC, FDA and CMS Guidance

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