A new COVID-19 test from the Abbott medical device company can yield positive results in five minutes and can be performed 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 does not need to be sent to a central laboratory for analysis. Instead, it can be done directly in an emergency room or an emergency clinic, which can shorten the waiting days of some patients now have for test results. Doctors can take a cotton swab from a patient’s nose or throat and place 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 on the market, starting next week, a quick point-of-care #coronavirus test, with positive results in 5 minutes and negative results in 13 minutes. Provides 50K tests / day to get started. Kudos to Abbott and Jeff Shuren of the FDA and the team at CDRH who are in the fray.
– Scott Gottlieb, MD (@ScottGottliebMD) March 28, 2020
“Rapid testing at ID NOW allows healthcare providers to perform molecular point-of-care testing outside the traditional four walls of a hospital in outbreak hotspots,” said Robert B. Ford, Abbott’s president and chief operating officer, 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, lasts 45 minutes. That test is primarily for emergency and hospital care, not for doctor’s offices or emergency clinics.
Tests that provide doctors with prompt answers are critical during disease outbreaks as they can help them know how much protective equipment to wear when in contact with a patient, where to go in a hospital, and what type care they should provide. Tests done in a doctor’s office can also help diagnose patients with mild or asymptomatic cases of COVID-19 and prevent them from knowingly spreading the virus.
The Abbott test works differently from the types of tests that were the norm during the pandemic in the US. Normally, a patient sample is sent to a laboratory so that it can be processed using a method called PCR, which searches for small pieces of genetic material from the coronavirus. In order for PCR to work, the sample must be cycled repeatedly over high heat and then down again. The Abbott test also searches for virus genetic material, but it works at a single temperature. That’s why the device it works on can be so small – it doesn’t need that much energy.
Abbott says it plans to ship 50,000 ID NOW COVID-19 tests per day starting next week.
The US struggled to speed up testing for the coronavirus, which is one of the reasons the public health system was unable to contain the virus before the number of cases began to rise. Commercial and state laboratories now run more than 100,000 tests per day, but the U.S. still performs fewer per capita tests than many other countries. President Donald Trump promised that there would be easy access to drive-through test sites in parking lots across the country, but there are not enough tests available to enter that type of system.
There are more cases of COVID-19 in the US than in any other country in the world.