Coronavirus Test Approved by FDA Can Issue Positive Results in 5 Minutes, Negative Results in 13 Minutes

Abbott Laboratories has won approval for a coronavirus test that can give positive results in just five minutes.

The company announced on Friday that the U.S. Food and Drug Administration (FDA) had issued an Emergency Use Authorization (EUA) for the fastest available point-of-care test that can detect the novel coronavirus, delivering positive results in as little as 5 minutes and negative results in 13 minutes.

The test, which runs on Abbott's ID NOW platform, can be used in physicians' offices, urgent care clinics and hospitals. The company says the ID NOW platform is already the most widely available molecular point-of-care testing platform in the U.S.

Abbott said it will start distributing the test next week and will ramp up manufacturing to deliver 50,000 tests a day.

"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 Ford, president and chief operating officer at Abbott, said in a statement.

Covid testing
A police officer mans the entrance to a coronavirus (COVID-19) testing center in Hansen Dam Park on March 25, 2020 in Pacoima, California. Frederic J. Brown/AFP via Getty Images

"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 spots."

Last week, the FDA approved a test made by Cepheid that can also be used at the point of care.

The FDA last week also approved another diagnostic test made by Abbott to be used in laboratories on its m2000 RealTime System platform, which is currently installed in 175 hospitals and labs across the country. Abbott said last week that it would immediately distribute 150,000 of those tests across the U.S. and ramp up production to a million tests per week.

Abbott said that between the two platforms, it expects to produce around 5 million tests a month.

The news comes as the U.S. became the country with the most confirmed cases of COVID-19, the disease caused by the novel coronavirus, despite struggling to meet the demand for testing.

Dr. Anthony Fauci, the director for the National Institute of Allergy and Infectious Diseases who is on President Donald Trump's top Coronavirus Task Force, told NPR on Thursday that the testing situation is now "infinitely better than what it was a few weeks ago."

He added, "In the beginning, it was a slow start. But right now that the commercial firms have gotten involved we really have caught up and we will be seeing a much more improved system with regard to the availability and the implementation of testing."

The U.S. has more than 104,000 cases of the coronavirus and more than 1,700 deaths, according to Johns Hopkins University. Almost 900 people have recovered. Worldwide, the virus has sickened more than 600,000 people and killed almost 28,000. More than 131,000 have recovered.

The infographic below, provided by Statista, shows the increase of coronavirus cases in selected U.S. states between March 16 and 26.

Coronavirus New York
Steep increase in coronavirus cases in New York. Statista

World Health Organization advice for avoiding spread of coronavirus disease (COVID-19)Hygiene advice

  • Clean hands frequently with soap and water, or alcohol-based hand rub.
  • Wash hands after coughing or sneezing; when caring for the sick; before, during and after food preparation; before eating; after using the toilet; when hands are visibly dirty; and after handling animals or waste.
  • Maintain at least 1 meter (3 feet) distance from anyone who is coughing or sneezing.
  • Avoid touching your hands, nose and mouth. Do not spit in public.
  • Cover your mouth and nose with a tissue or bent elbow when coughing or sneezing. Discard the tissue immediately and clean your hands.

Medical advice

  • Avoid close contact with others if you have any symptoms.
  • Stay at home if you feel unwell, even with mild symptoms such as headache and runny nose, to avoid potential spread of the disease to medical facilities and other people.
  • If you develop serious symptoms (fever, cough, difficulty breathing) seek medical care early and contact local health authorities in advance.
  • Note any recent contact with others and travel details to provide to authorities who can trace and prevent spread of the disease.
  • Stay up to date on COVID-19 developments issued by health authorities and follow their guidance.

Mask and glove usage

  • Healthy individuals only need to wear a mask if taking care of a sick person.
  • Wear a mask if you are coughing or sneezing.
  • Masks are effective when used in combination with frequent hand cleaning.
  • Do not touch the mask while wearing it. Clean hands if you touch the mask.
  • Learn how to properly put on, remove and dispose of masks. Clean hands after disposing of the mask.
  • Do not reuse single-use masks.
  • Regularly washing bare hands is more effective against catching COVID-19 than wearing rubber gloves.
  • The COVID-19 virus can still be picked up on rubber gloves and transmitted by touching your face.