Dr. Shawn Shroff, a primary care physician in Quincy, gets the request often these days: Anxious patients with fevers and sniffles want to get tested for the new coronavirus.
But Shroff, who works at a Tufts Medical Center practice, has found himself in the uncomfortable position of having to say no. The reason? He has been prohibited from sending samples for testing at the state lab unless the patient meets strict federal criteria.
“I have to advise them that we don’t have that particular test specifically, but we can rule out other respiratory viruses, including the flu," he said.
The situation has been baffling for patients and frustrating for physicians. But an announcement late Tuesday may change that: Vice President Mike Pence said the US Centers for Disease Control and Prevention will lift all restrictions on testing and release new guidelines for testing even people with mild illness.
The new guidance “will make it clear that any American can be tested," subject to doctor’s orders, Pence said.
Eric Blank, chief program officer for the Association of Public Health Laboratories, said Pence’s comments won’t instantly alter the testing landscape. “In the immediate future, not much is going to change," he said, noting he was offering his own opinion and not speaking for the association.
Laboratories are obliged to follow regulations spelled out in an emergency authorization from the US Food and Drug Administration that does not call for such widespread testing, he said.
Additionally, laboratories don’t currently have the capacity to immediately test every sick American. Nearly half the public health laboratories still did not have coronavirus test kits on Tuesday morning, and efforts to involve private laboratories are just getting off the ground.
The CDC has taken a slow path to testing, and stumbled along the way. Originally only the CDC had the capacity to perform the tests for the coronavirus. Then, the test kits it distributed to public health laboratories early last month didn’t work.
Now, the federal government is working with private manufacturers and laboratories to boost testing capacity, predicting that 2,500 test kits would go to private labs by the end of the week. The kits contain vials of reagents used to detect the virus in swabs from the nose or throat of patients.
Meanwhile, doctors like Schroff have had to appeal to their patients’ forbearance. “After I discuss with them why this is the case they seem to understand overall,” he said.
Until now, testing has been allowed only for symptomatic people who have had close contact with a patient with Covid-19, the illness caused by the virus, or who have traveled to one of five affected nations. Testing has also been permitted for people with severe lower respiratory illness, such as pneumonia.
That last category has proven especially troublesome.
"There has been quite a bit of anxiety [among patients and providers] because this ‘person under investigation’ definition most heavily emphasizes people ill enough to require hospitalization,” said Dr. Preeti Mehrotra, medical director of infection control at Atrius Health, a large Eastern Massachusetts group practice with 30 sites. As of late Monday, Atrius doctors had not treated any patients who met CDC criteria for testing.
Dr. Erica Shenoy, associate chief of infection control at Massachusetts General Hospital, said it’s hard to know exactly what the CDC means by “severe" illness. "One person’s definition of severe pneumonia may be different than another,” she said.
Doctors seeing patients with severe symptoms will first administer a flu test, and if it’s negative, they can discuss testing for the coronavirus with the state Department of Public Health, Shenoy said. Meanwhile, patients still have to be isolated as if they had Covid-19, she said.
Doctors have been swamped by the very time-consuming process of determining who is eligible for testing, Shenoy said.
“Most patients think there’s a test there like a flu test or strep test,” she said. “I am fielding a lot of calls saying, ‘I just got back from Italy. Can I just get tested?’ ”
As of Tuesday morning, 54 local and state public health labs around the country were able to perform the test for the coronavirus, according to the Association of Public Health Laboratories. They included Massachusetts, which announced Monday evening that its laboratory had detected the probable second case of Covid-19 in the state. But the CDC still needs to verify positive tests done in state labs.
Once all 100 local and state public health laboratories begin testing, they will be able to handle 10,000 patients a day, the association said.
“We heard that 337 kits have gone out,” Blank said Tuesday. Each kit can test 350 patients.
“We do now have reliable tests that seem to work well in the hands of public health laboratories,” Blank said. “It will be interesting to see how this testing will go in the private health care sector and what will be available there.”
The US Food and Drug Administration is working with private manufacturers and academic medical centers to allow them to do their own testing. Once that gets off the ground, the capacity will increase greatly. But Blank expressed skepticism about claims by FDA director Stephen Hahn that 1 million people would be tested this week. That is more likely to take several weeks, he said.
The CDC started out with very restrictive criteria for testing because it was trying to contain the virus, by identifying infected individuals and their contacts, Blank said. That approach meant that the virus spread quietly among people who didn’t meet the definition. Many people have mild cases or no symptoms at all.
But now that it’s become clear the virus is spreading among people who haven’t traveled to affected countries or had contact with Covid-19 patients, “public health is starting to shift away from containment,” Blank said.
Eventually, he said, the system will move to surveillance, in which the focus is not on identifying every individual who’s infected but rather testing a sampling of symptomatic people to track where the virus is spreading and how long it lingers. This is how the flu is tracked.