FDA approves new home coronavirus testing kit

World

Published: 2020-12-16 11:33

Last Updated: 2024-04-23 20:40


Picture from the NYTimes
Picture from the NYTimes

The US Food and Drug Administration Tuesday issued an emergency authorization for America's first at-home COVID-19 test that does not require a prescription.

The kit is produced by the Australian company Ellume. Results are produced in 15 to 20 minutes based on whether or not coronavirus antigens were detected.

Tests can be conducted on children as young as two years old.

Ellume's testing kits are less accurate than gold standard laboratory tests, such as the PCR test. A clinical study involving approximately 200 people showed that the product was able to detect COVID-19 in 95 percent of people who tested positive with PCR tests. It also correctly yielded negative results for 97 percent of people who tested negative for COVID-19 using PCR tests.