FDA approves Quest Diagnostics for COVID-19 pooled testing
UPDATED 7:41 AM PT — Sunday, July 19, 2020
The federal government has introduced a new way to speed up coronavirus testing without depleting medical supplies.
On Saturday, the FDA issued an emergency order giving Quest Diagnostics the go-ahead to begin collecting pooled samples of tests. This will allow Quest to test up to four specimens at the same time, which will free up testing kits to use on more residents.
“Instead of taking an individual blood sample, a nasal sample from somebody, you take a whole bunch of them and you put them together, and you run a test on that whole batch,” explained Dr. Amesh Adalja, senior scholar at Johns Hopkins University Center for Health Security. “And then if it’s negative, all those people are clear, but if it’s positive then you can go back and individually test those samples to see who was positive.”
FDA officials said pooled testing is an important step in combating the coronavirus, especially when infection rates decline and health official begin testing larger populations. They predicted that this strategy will work best in areas where infection rates are lower and believe positive cases will be easier to detect as well as track.
— U.S. FDA (@US_FDA) July 18, 2020
Additionally, officials claimed Quest’s procedures for validating data tackles any problem that could arise when samples are combined in a laboratory setting.”
“It’s a very useful technique that’s been used in 50-70 years, we showed that,” stated Dr. Christopher Pilcher, professor at UCSF. “Given what we know now about coronavirus infections , it seems like the benefits are going to greatly outweigh the loss of detection you get.”
Officials said they are working with other diagnostic test developers to come up with new strategies to quickly test more Americans.