Abbott Laboratories has received authorization from the U.S. for a rapid COVID-19 test that not only costs $25 but can be administered at the comfort of your own home. The cost of the test is said to cover both the test and additional eMed’s services.
Testing thus far
The increase in testing has been key to fighting this unrelenting virus, but it has also been hard to access at times. People looking to get tested have frequently faced slow turnaround times, high costs, and long lines, which presents significant challenges when people without symptoms may be infectious or when people need to report back to work.
Public-health experts continue to call for more accessible screening and testing and criticize the FDA for moving too slowly on green-lighting new applications. Abbott Laboratories’ rapid test has received U.S. authorization just in time to aid the post-holiday surge of coronavirus cases, as well as the new strain of the virus that was discovered in the UK.
Abbott’s rapid test
The test, which is an antigen test that delivers results in about 15 minutes, had previously been authorized for use by trained personnel only, but the new clearance will allow patients to test themselves at home with virtual assistance from a doctor. It’s the third test authorized in the U.S. “that can be used completely at home,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
“FDA continues to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options,” said FDA Commissioner Dr. Stephen Hahn. “The BinaxNOW COVID-19 At Home Test will have a significant manufacturing footprint with the potential to support testing for millions of people.”
“FDA’s authorization of the BinaxNOW card test for home use means we should have tens of millions of COVID-19 tests in the coming months that Americans can use without leaving their home,” said Health and Human Services Secretary Alex Azar. Abbott said it expects to deliver 30 million at-home tests in the first quarter of 2021, with another 90 million in the second quarter. The FDA noted that antigen tests are not as accurate as many molecular tests.
Reason for at-home testing
Although the need for rapid testing has risen during the pandemic, “Unfortunately, we’re still hearing that many people can’t access testing as quickly as they need it,” said Robert Ford, Abbott’s chief executive officer. The new offering “allows us to maintain the integrity of the testing process, get even closer to people who need testing, and help provide the confidence we need to help get back to living with a bit more normalcy,” he added.
One of the priorities for regulators around at-home testing has been ensuring that it’s easy for the public to use and that results are reported to public health officials.
In an ongoing study of 52 people who used the at-home offering within a week of developing symptoms, the test accurately produced positive results about 92 percent of the time, and correctly returned negative tests 100 percent of the time, the company said. The test was especially accurate for a subset of patients who were more likely to be infectious, according to Abbott, producing true positives in 100 percent of cases.
How to access rapid tests
Patients can order the test through the Abbott-developed Navica smartphone app, where they will fill out a series of health questions. Abbott’s prescribing partner, eMed, ships the test and virtually supervises its administration. Results are then delivered through the Navica app.
Note: While at-home options are certainly a step forward, lower-cost significantly, and have a wider reach, health experts say more widespread access is still needed.