FDA grants emergency use authorization for a new rapid point-of-care molecular SARS-CoV-2 diagnostic.
The US Food and Drug Administration (FDA) has issued an emergency use authorization for a new rapid point-of-care molecular SARS-CoV-2 diagnostic. The test, which was developed by Abbott, delivers positive results for COVID-19 infection in 5 minutes and negative results in 13 minutes, according to a statement from the company.
The newly approved test utilizes Abbott's ID NOW platform, which is a portable 6.6-pound device. The ID NOW platform is already in standard use in the United States as a molecular point-of-care device for influenza A and B, Strep A, and respiratory syncytial virus. The COVID-19 test will be available within days, with Abbott's manufacturing capacity prepared to deliver 50,000 tests per day, the company noted.
"The COVID-19 pandemic will be fought on multiple fronts, and a portable molecular test that offers results in minutes adds to the broad range of diagnostic solutions needed to combat this virus," Robert B. Ford, president and chief operating officer, Abbott, said in the statement. "With rapid testing on ID NOW, healthcare providers can perform molecular point-of-care testing outside the traditional four walls of a hospital in outbreak hotspots."
The process for using the new test involves placing the sample in a chemical solution, to release genetic material by breaking down the virus. The ID NOW platform then uses isothermal amplification of identified nucleic acids, to allow for detection of the virus. For the test, the diagnostics targets the coronavirus RdRp gene for detection.
Samples for the test, in direct or viral transport media, can be collected using a throat, nasal, nasopharyngeal, or oropharyngeal swab. The COVID-19 test kit includes 24 tests, swabs for sample collection, pipettes, and positive and negative controls.
"Through the incredible work of teams across Abbott, we expect to deliver 50,000 COVID-19 tests per day to healthcare professionals on the frontlines, where testing capabilities are needed most," Chris Scoggins, senior vice president, Rapid Diagnostics, Abbott, said in an article posted to the company’s website. "Portable molecular testing expands the country's capacity to get people answers faster."
In addition to the point-of-care test, on March 18, Abbott has also received emergency authorization for a RealTime SARS-CoV-2 test. Upon approval, the company was capable of shipping 180,000 of these tests, which uses the m2000 RealTime System. Between these two approved tests, Abbott is prepared to produce 5 million tests for COVID-19 in April, according to the company.
"This is [a] game changer," said former FDA commissioner Scott Gottlieb, MD, on Twitter. "It’s very likely that we’ll see additional approvals of point-of-care diagnostics behind this one, extending testing to doctor offices across the United States."
As of March 27, 2020, the FDA had issued over 19 emergency use authorizations for COVID-19 diagnostics, according to the agency. Additionally, over 110 laboratories have begun testing for the virus under policies put in place by the agency.
At the time of this article, there were over 600,000 globally reported confirmed cases of COVID-19 infection, with the number rapidly growing in the United States to beyond 100,000. Additional novel diagnostics are expected to enter the market through the FDA's emergency authorization program in the next weeks.
For the most recent case counts in the COVID-19 outbreak, check out the Contagion® Outbreak Monitor