FDA emergency approval granted for 5-minute SARS-CoV-2 point-of-care test

The US Food and Drug Administration (FDA) has issued emergency use authorization (EUA) for a molecular point-of-care SARS-CoV-2 test that promises to deliver results in minutes.

Developed by Abbott Laboratories, the test is built to run on the company’s existing ID NOW^TM testing platform, a portable 3 kg machine which can be used in physicians’ offices, urgent care clinics and hospital emergency departments, according to a press statement by the company.

“ID NOW is a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases. Its unique isothermal nucleic acid amplification technology provides molecular results in just minutes, allowing clinicians to make evidence-based clinical decisions during a patient visit,” said Abbott representatives.

In a brief video, the company explained that the test devised for detection of SARS-CoV-2 focuses on identifying a small section of the viral genome and rapidly replicating it to detectable levels, with positive results delivered as rapidly as 5 minutes and negative results in 13 minutes. [https://www.youtube.com/watch?v=MqICkkOaNKo]

First released in 2014, ID NOW machines are already in use in US healthcare facilities for testing other infectious diseases such as influenza A and B, Group A streptococci, and respiratory syncytial virus (RSV). The company has announced it will be working with the US government to deploy the ID NOW SARS-CoV-2 tests in early April to urgent care settings across the country, with test production being accelerated to 50,000 units per day.

“Through the incredible work of teams across Abbott, we expect to deliver 50,000 COVID-19 tests per day to healthcare professionals on the front lines, where testing capabilities are needed most,” said Chris Scoggins, senior vice president, Rapid Diagnostics, Abbott.

At the time of reporting, the US has the highest number of COVID-19 cases in the world, with over 140,000 individuals confirmed positive for the virus. Globally, cases have exceeded the 720,000 mark.

“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. “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.”

Prior to the approval of the ID NOW SARS-CoV-2 test, the company had also received an FDA EUA for a test utilizing its m2000 RealTime system, which is used in hospitals and laboratories. Between the two platforms, the company expects to produce an estimated 5 million tests per month.

According to Abbott Laboratories’ director of public affairs Sharon Mak, the ID NOW SARS-CoV-2 test is available only in the US currently as it is where most ID NOW instruments are located.

“Abbott is developing COVID-19 tests across our testing platforms, including laboratory and lateral flow tests, and plans to bring more tests forward with the intent to get them to more people in more places around the world,” said Mak. “We are working to produce as many tests as possible, running our production 24/7 and will expand manufacturing capacity when we can.”

Multiple pharmaceutical and medical device companies are racing to develop rapid tests for SARS-CoV-2 as the pandemic continues to cross the globe. On 13 March, FDA EUA was also granted to Roche Holding AG’s rapid test on the company’s cobas® 6800/8800 systems, which provide results in 4 hours and can test 1,440 to 4,128 patients a day. [https://www.thestar.com.my/news/regional/2020/03/13/us-approves-roche039s-new-and-faster-covid-19-test]