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FDA Authorizes Non-Prescription Covid-19 Test

Cue Covid-19 test

Cue Covid-19 test. Click on image for full-size view (Cue Health Inc.)

6 Mar. 2021. Food and Drug Administration granted an emergency authorization for a molecular test for SARS-CoV-2 viruses done at home without a prescription. The FDA’s action authorizing the Cue Covid-19 Test by Cue Health Inc. in San Diego is the first clearance for an over-the-counter molecular test of viruses responsible for Covid-19 infections.

The Cue Covid-19 Test uses mid-nose nasal swabs to collect a sample for analysis, rather than the deep nasopharyngeal swab used in professional RT-PCR tests that require a clinician. Adults can take swabs from their own nose or from children age two or more. The swab is inserted in a single-use test cartridge that amplifies RNA in the sample for analysis, with the cartridge then inserted into a cartridge reader. The reader returns results in about 20 minutes, displayed on a companion mobile app, available only for Apple iPhone 8 Plus or newer and iOS version 13 or higher. The company says an Android version of the app is in development.

Cue Health tested its Covid-19 test in August 2020 at a Mayo Clinic drive-through testing facility in Mankato, Minnesota, with results published in the journal Diagnostic Microbiology and Infectious Disease. Some 292 individuals were randomly assigned for conventional RT-PCR testing or the Cue Health test. The results show positive tests for SARS-CoV-2 viruses with the Cue Health test matched RT-PCR tests 92 percent of the time, with negative tests from the Cue Health device matching RT-PCR results 98 percent of the time.

The Cue Health test was first authorized by FDA for clinical use in June 2020, and the company says it’s now in use in doctors offices, hospitals, schools, businesses, dental clinics, and long-term care facilities. FDA says Cue Health plans to produce 100,000 tests by the summer of 2021. “For the first time,” says  Ayub Khattak, co-founder and CEO of Cue Health in a company statement, “consumers can access laboratory-grade testing at home. This is an important milestone in the advancement of Covid-19 testing.”

As reported by Science & Enterprise on 1 Mar., FDA authorized another home test for antigens indicating the presence of SARS-CoV-2 viruses, but requires a prescription. Quidel Corp., the company developing the test, says it plans to submit findings to FDA for clearance also as a home over-the-counter test.

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