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Coronavirus Updates: FDA Approves At-Home COVID Test Kit

This is our daily update of breaking COVID-19 news for Wednesday, December 16th, 2020. Previous daily updates can be found here, and up-to-date statistics are here.

New York City is in Phase 4 of reopening now, which includes zoos, botanical gardens, museums, and gyms. Citing rising hospitalization rates, Governor Andrew Cuomo suspended indoor dining in NYC starting Monday, December 14th. After being shut down for several weeks, NYC public schools partially reopened on December 7th for 3K-5th grade students, with students with special needs returning on December 10th. Certain parts of Staten Island remain under a zoned shutdown.

Get answers to questions you may have with our “Ask An Epidemiologist” series, or learn more about NYC COVID-19 testing options with our explainer. Here are some local and state hotlines for more information: NYC: 311; NY State Hotline: 888-364-3065; NJ State Hotline: 800-222-1222.

Here’s the latest:

The United States has approved emergency usage of an at-home COVID-19 test, which can be used for adults as well as children over two years old.

The Food and Drug Administration granted Emergency Use Authorization to Ellume for its COVID-19 Home Test, an over-the-counter product that can be used on both symptomatic and asymptomatic people. Ellume, an Australian company, was developed the kit with $30 million from the National Institute of Health’s RADx program, which was created to accelerate technologies for COVID-19 testing.

According to the company, users download an app and follow directions “to perform the test including a self-collected mid-turbinate swab.” The user can put the swab into a single-use cartridge that analyzes it and, by way of Bluetooth, sends results to the user’s smartphone. The FDA says, “Results are delivered in as little as 20 minutes… The mobile application requires individuals to input their zip code and date of birth, with optional fields including name and e-mail address, and reports the results as appropriate to public health authorities to monitor disease prevalence.”

“It’s a big deal, and a huge step for efforts to take back control from the virus,” Mara G. Aspinall, a biomedical diagnostics professor at Arizona State University, told the Washington Post.

The kit uses an antigen test, which is less sensitive than the PCR (polymerase chain reaction) test. The use of antigen test results, versus PCR test results, is the subject of debate among health experts. Some states, municipalities, and agencies include antigen tests in their calculation of positive testing rates (like New York state does), while others, like the Centers for Disease Control, rely solely on PCR tests. For much of the pandemic New York City did not include antigen tests in its positivity rate—causing the discrepancy with state data—but now breaks out both types of results.

In Ellume’s data, a study of 198 people showed that it was 96% accurate: It was able to determine with 95% accuracy people who had COVID-19 as tested with a PCR test, and, with 97% accuracy, those who were negative by a PCR test. The FDA noted, “The FDA reminds patients that all tests can experience false negative and false positive results. Individuals with positive results should self-isolate and seek additional care from their health care provider. Individuals who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not preclude an individual from SARS-CoV-2 infection.”

Ellume expects to increase production to 100,000 kits a day in January, and the company expects to announce a partnership with a major U.S. pharmacy chain. The Australian government also gave $37 million to help Ellume expand its manufacturing. Notably, Australia, which has a very low positive test rate, does not authorize use of at-home testing kits.

Also on Tuesday: California Governor Gavin Newsom announced the state had ordered 5,000 body bags and 60 refrigerated morgue trucks. California’s positive test rate is just over 10%, with over 30,000 new COVID-19 cases announced each day. Newsom said, “There is light at the end of the tunnel, but we’re still in the tunnel. And that means we’re going through perhaps the most intense and urgent moment since the beginning of this pandemic.”

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