FDA GIVES EMERGENCY OK FOR AT-HOME COVID TEST

No prescription will be needed to purchase, run test

The Food and Drug Administration Tuesday issued an emergency authorization for the country’s first coronavirus test that can run from start to finish at home without the need for a prescription.

People as young as 2 years old are cleared to use the test, which takes just 15 to 20 minutes to deliver a result. Unlike many similar products, which are only supposed to be used by people with symptoms of COVID-19, this test is authorized for people with or without symptoms.

The test, developed by Australian company Ellume, detects bits of coronavirus proteins called antigens. It’s slightly less accurate than gold-standard laboratory tests designed to look for coronavirus genetic material with a technique called polymerase chain reaction, or PCR. But in a clinical study of nearly 200 people, Ellume’s product was able to detect 95 percent of the coronavirus infections found by PCR, regardless of whether the infected people felt sick. It also correctly identified 97 percent of the people who received negative laboratory test results.

Ellume, which was awarded a $30 million grant from the National Institutes of Health, said it planned to manufacture and deliver about 20 million home coronavirus tests to the United States within the first half of 2021. Each kit, which tests a single swab sample, is expected to cost about $30 or less, said Bella Zabinofsky, a spokesperson for the company.

In a statement, FDA Commissioner Stephen Hahn called Ellume’s authorization “a major milestone in diagnostic testing for COVID-19” in light of the coronavirus’s persistent grip on the nation. The product will be available in drugstores, Hahn noted, and gives Americans “more testing options from the comfort and safety of their own homes.”

Ellume’s test works best in people with COVID symptoms. In people without symptoms, the product’s accuracy dropped a bit, finding 91 percent of the coronavirus infections discovered by PCR.

Dr. Valerie Fitzhugh, a pathologist at Rutgers University, noted that all of the study’s false positives occurred in the asymptomatic group. That “does make me a little nervous,” Fitzhugh said. False positives could send people into unnecessary periods of isolation or erode trust in testing, among other issues.

In a statement announcing Ellume’s emergency clearance, the FDA underscored the importance of recognizing false positive and false negative results, both of which are more common with antigen tests. People without symptoms who test positive, the agency said, should confirm their results with another test.