Five-Minute COVID-19 Test Now Available
Abbott gains emergency use authorization from the FDA for its point-of-care diagnostic test
Rachel Muenz is the managing editor of G2 Intelligence and was previously senior digital content editor at Lab Manager, a publication dedicated to teaching lab professionals the management skills they need to run their laboratories as effectively as possible. She has more than 10 years of experience as a writer, editor, and curator of both print and digital content, with the majority focused on laboratory topics. Rachel holds an honors bachelor of arts degree in English from the University of Toronto and a diploma in journalism from Centennial College. Rachel regularly contributes news and insights to Today's Clinical Lab.
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Health care providers gained a new tool in the fight against COVID-19 when the US Food and Drug Administration (FDA) granted Abbott emergency use authorization (EUA) for its point-of-care (POC) test to detect SARS-CoV-2 on Mar. 27.
The test, which the company claims is currently “the fastest available molecular point-of-care test” for the virus that causes COVID-19, can provide positive results in as little as five minutes and negative results in 13 minutes.
"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," said Robert B. Ford, president and chief operating officer, Abbott, in a recent press release. "With rapid testing on ID NOW, health care providers can perform molecular point-of-care testing outside the traditional four walls of a hospital in outbreak hotspots."
Designed to run on Abbott’s toaster-sized ID NOW™ platform which is already widely used in the US, the tests are being made available this week to American health care facilities hardest hit by COVID-19, the company said in a recent release. There are now 18,000 ID NOW™ platforms being used in the country, according to a USA Today article.
The company adds that, between this latest test and its Abbott m2000™ RealTime SARS-CoV-2 EUA test released the previous week, it “expects to produce about 5 million tests per month” and 50,000 of the ID NOW COVID-19 tests per day, starting this week.
After initially having only 23 test kits per million people, the US continues to ramp up its testing capacity as the FDA grants EUA to more companies for their COVID-19 diagnostic test kits. As of early afternoon on Apr. 1, the administration had granted EUA to 22 different test kits and companies are producing hundreds of thousands of those kits per week.