FDA approves new rapid result, at home coronavirus test

The Food and Drug Administration has issued an emergency authorization for the country's first at-home coronavirus test.

The test was approved Tuesday and takes 15 to 20 minutes to yield a result. It can be used on individuals as young as 2 and does not require a prescription.

The test by Australian company Ellume can detect 95% of coronavirus cases that the full laboratory polymerase chain reaction (PCR) test was able to detect, according to a clinical study. The test also correctly recognized 97% of negative coronavirus cases.

The test begins with a self-conducted nasal swab that is then plugged into a cartridge and analyzed. Data is then sent to a smartphone via Bluetooth and the results arrive with the person who took the test. Results can be shared with health care providers and public health authorities as well. 

Unlike similar rapid tests, the Ellume test is authorized for use by people with and without coronavirus symptoms. However, the test is most accurate on individuals who have begun experiencing symptoms within a few days of taking the test. All of the study's false positives occurred in the group of asymptomatic patients.

Ellume received a $30 million grant from the National Institutes of Health and plans to deliver about 20 million home tests to the U.S. over the next six months or so. The tests will sell for $30 or less.