Time: Why It's So Hard to Get Cornovirus Testing in the U.S. Right Now


Article in Time Magazine related to the challenges of diagnostic testing


BY ALICE PARK MARCH 12, 2020

When employees of Massachusetts biotech company Biogen were informed in late February that several among them had been diagnosed with COVID-19 after a company-wide meeting, they immediately went to hospitals for testing, but were turned away. Because of the scarce number of tests available in the U.S., doctors, upon the advice of the Centers for Disease Control (CDC), were following strict protocols for who could be tested: people who had symptoms and had traveled to a country where cases were endemic, or had been in close contact with someone who had tested positive. Most of the Biogen employees didn’t have any of the symptoms of fever, cough or difficult breathing that are the hallmarks of COVID-19, but understandably wanted to know if they had been exposed.Two weeks after the meeting, 77 of Massachusetts’ 95 confirmed cases are Biogen employees.The criteria for who can be tested have since been relaxed, and doctors can now order the test for any patient, using their best judgement on whether it’s necessary. Still, testing in the US lags far behind that in other countries, due to a combination of technical and policy issues, as well as political pressure.


When the first cases of COVID-19 were reported in the US, two labs at the CDC were the only ones permitted to conduct COVID-19 testing, using a test developed by the agency’s own researchers. When the CDC tried to expand testing by providing its test kits to state and local public health labs, there were problems with the initial version of the kits, which the CDC then reworked.



That delay, along with the growing number of undetected cases in the U.S., prompted the Food and Drug Administration (FDA) on Feb. 29 to expand its approval criteria to allow any qualified lab to develop its own test. Two of the largest diagnostic commercial labs, Quest Diagnostics and LabCorp, have begun testing this week but are still conducting only a few thousand a day as they scale up capacity.


“My people have been working all weekend, 24-7,” says Dr. Jon Cohen, CEO of BioReference Laboratories, which plans to roll out its test this week. “Within a week, if not sooner, we should be able to do 1,000 to 2,000 tests a day, and from there, scale up higher.” A spokesperson for North Carolina-based LabCorp says the company has been conducting several thousand tests a day since March 5, and plans to add staff and equipment to increase that number. Quest Diagnostics, based in New Jersey, says the company released its COVID-19 test on March 9, and plans to perform tens of thousands of tests a week within six weeks.


Taken together, that’s still a tiny fraction of the number that should be conducted in a country of 327 million people, say experts. As of March 11, CDC, state and public health labs have conducted more than 11,000 tests since mid-January. By comparison, South Korea has tested more than 200,000 of its population of 51 million since January.

In the US, rollout of widespread testing is plagued by not only logistical issues but political over-promising and supply constraints. When the FDA expanded its approval criteria at the end of February, agency commissioner Dr. Stephen Hahn predicted that the policy would lead to enough test kits for more than a million people within a week; when that goal wasn’t met, White House Coronavirus Task Force point person Mike Pence was forced to extend the target date by a week as companies scrambled to familiarize themselves with the test and order the chemicals and reagents they needed.


Even when tests are available, there’s the question of how and where people will take them. Because COVID-19 is proving highly contagious, doctors and hospitals are reluctant to encourage people with symptoms to come into offices to provide samples. Public health officials and lab companies are exploring new ways of running these tests, including at drive-through facilities, or separate tents that some hospitals are setting up outside of their emergency rooms, to minimize contact that potentially positive people would have with other patients.



206.228.5990

We'd Love to Hear From You

Copyright © 2020 Empowered Diagnostics. All rights reserved.

This information—including product information—is intended only for residents of the United States. The products discussed herein may have different labeling in different countries.