A new COVID-19 test from the medical device company Abbott can return positive results in five minutes — and it can be run in a doctor’s office. The test was approved for emergency use in the United States by the Food and Drug Administration last night.
The test uses Abbott’s small, portable ID NOW platform, and doesn’t have to be sent to a central lab for analysis. Instead, it can be done directly in an emergency room or urgent care clinic, which could cut down on the days-long wait time some patients now face for test results. Doctors could take a swab from a patient’s nose or throat and insert it directly into the machine, and have results within 15 minutes (it can take up to 13 minutes if the sample is negative for the virus).
This is GAME CHANGER. Abbott to market, starting next week, a fast point-of-care #coronavirus test, delivering positive results in 5min and negative results in 13min. Will deliver 50K tests/day to start. Kudos to Abbott and FDA’s Jeff Shuren and team at CDRH who are in the fight.— Scott Gottlieb, MD (@ScottGottliebMD) March 28, 2020
“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,” said Robert B. Ford, president and chief operating officer of Abbott, in a press release.
This is the second point-of-care test for COVID-19 approved by the FDA. The first, from the biotechnology company Cephid, takes 45 minutes. That test is primarily intended for emergency rooms and hospitals, not for doctors’ offices or urgent care clinics.
Tests that give doctors answers quickly are critical during disease outbreaks, because they can help them know how much protective equipment they need to wear when they’re interacting with a patient, where in a hospital to send them, and what sort of care to provide. Tests done in a doctor’s office can also help diagnose patients with mild or asymptomatic cases of COVID-19, and help stop them from unknowingly spreading the virus.
The Abbott test works differently than the types of tests that have been the standard in the US during the pandemic. Normally, a patient sample gets sent to a lab so it can be processed using a method called PCR, which searches for tiny bits of coronavirus genetic material. For PCR to work, the sample has to be repeatedly cycled up to a high heat and then back down again. The Abbott test also looks for virus genetic material, but it works at one single temperature. That’s why the device it runs on can be so small — it doesn’t need as much energy.
Abbott says it plans to start shipping 50,000 ID NOW COVID-19 tests a day starting next week.
The US struggled to ramp up testing for the coronavirus, which is one reason the public health system wasn’t able to contain the virus before case numbers started to climb. Commercial and state labs are now running upwards of 100,000 tests per day, but the US is still running fewer tests per capita than many other countries. President Donald Trump promised that there would be easy to access drive-through testing sites in parking lots across the country, but there aren’t enough tests available to put that type of system in place.
There are more cases of COVID-19 in the US than in any other country in the world.