Lindsey Mace, of Richmond, did exactly what she was supposed to do when she started feeling sick last week. She called her doctor at Richmond Family Practice and listed her symptoms: run-down and tired, with a lot of pressure in her chest and head.
“It was at the point where I felt tired just taking the dog out,” Mace said. She thought it might be the flu or a sinus infection, but when she went into the office on Friday morning, a staff member there immediately handed her a surgical mask. They were wearing masks, too, and Mace stood in a hallway outside the entrance — away from the main waiting area — until her doctor brought her back to an examination room.
Mace said he asked her questions about her travel history and risk of exposure to COVID-19, the disease caused by a new strain of coronavirus. He asked about her medical history, and whether her anemia could be playing a role (blood tests showed her iron levels were fine, and she had just recently received an iron infusion). Her flu test was negative, and she said her doctor told her she was on the threshold of requiring a test for the virus.
“But he said, ‘To be honest, we don’t even have tests here,’” Mace said. And though she had gone to a large public event the weekend before (the Richmond Mom Prom, which she estimated roughly 600 other women attended), she wouldn’t have met the threshold for testing by the Virginia Department of Health, which sets strict criteria aimed at high-risk patients and those with “close contact” to laboratory-confirmed cases of the disease.
“He said tests were very, very limited and they were being told not to test people,” Mace added. (Richmond Family Practice did not immediately respond to a request for comment for this story.)
So, like many patients in Virginia with symptoms of the virus but no known exposure, Mace went home. By Wednesday, she said, her doctor decided that she was sick with a sinus infection and cleared her to leave the house.
Since then, Mace said she’s run to the grocery store for toilet paper and gone out to walk the dog. But she still has nagging doubts about her diagnosis and whether she — like other Virginians — could be an unwitting transmission risk for COVID-19.
“Even now, going out without a mask, I question whether it’s the right thing to do,” she said. “Because I don’t have that sense of security. I can’t help but think how many other people like me could have potentially had it, even though we were told we don’t.”
Available tests rise to 1,000 Thursday
Limited testing is still an ongoing and increasingly pernicious problem in Virginia, where state health officials recently celebrated a significant increase in capacity at the state lab in Richmond. On Thursday, state epidemiologist Dr. Lilian Peake announced the lab could test approximately 1,000 patients total for COVID-19 — a marked increase after several days when capacity was estimated at fewer than 400 people.
“I’m really proud of our state lab staff, who are working around the clock to get the different supplies they need to run the test,” Peake said at a Thursday press briefing.
But it’s still nowhere near the level of testing that’s generally deployed for other outbreaks of infectious disease. Bryan Lewis, a computational epidemiologist at the University of Virginia’s Biocomplexity Institute (which recently began coordinating with the state to model the potential spread of COVID-19 in Virginia) said that most positive cases could potentially infect as many as 10 and 20 people a day.
For “full-bore, heavy-duty infection control,” as he described it, the state would trace — and test — every contact of an infected patient. If any of those people tested positive, their contacts would then be tested, allowing the state to chase down and isolate infections to avoid transmission.
“I think, with those numbers, you end up consuming maybe 20 to 30 tests per case,” Lewis said. As of Friday, the state had confirmed 114 cases of COVID-19, which would require roughly 2,280 to 3,420 tests if the state was screening every potential contact.
In Virginia, those numbers still appear far out of reach. Lewis said one of his colleagues at the Biocomplexity Institute recently tested positive for the virus after meeting the state’s criteria for testing. But other members of his family weren’t tested — and for good reason, Lewis said, given the limited number of tests.
“You shouldn’t waste a test on them because it’s obvious that they most likely do have COVID,” he added. But he also acknowledged that without testing, those family members might never be included in the state’s tally of positive cases, which have sometimes been inconsistent with numbers released by local health directors and military bases.
Virginia isn’t the only state struggling with limited testing capacity. The nationwide shortage has been described as a “failing” by Dr. Anthony Fauci, a key infectious disease specialist for the federal government.
Doctor: ‘I feel like they’re misleading people.’
But doctors and health care experts across Virginia have expressed frustration over the state’s continued limits on testing and how state officials have described the scope of the outbreak at daily press briefings. One doctor at a Richmond-area hospital, who spoke on the condition of anonymity to avoid repercussions from her supervisors, said she was especially aggravated when state officials definitively listed the number of cases in different regions of the state.
For days, Health Commissioner Dr. Norman Oliver told reporters that there were no cases of COVID-19 in southwest Virginia. That changed on Friday after the state reported its first positive test result, but the doctor said it didn’t reflect the limited testing being conducted throughout the state.
“I feel like they’re misleading people,” she said. “When you’re giving these numbers and saying there’s only one case in this county or this facility or whatever, they’re not following up with the fact that 70 percent of us could get this virus, in one form or another. It’s like saying, ‘Only one person in this bar has HIV, but we’ve only tested one person.’ That doesn’t accurately reflect the number of people who actually have it.”
As of Friday, 2,325 people in Virginia have been tested for COVID-19, including samples sent to private labs for testing. Several officials with the Virginia Department of Health, including Peake, have said the agency doesn’t track the number of requests it receives for testing, making it difficult to assess the number of patients who could have the disease.
Shortage of protective gear
For patients, the lack of testing can lead to frustrating uncertainty. For epidemiologists, it hinders efforts to track and limit the spread of disease. For health providers, it’s often frightening. The Richmond-area doctor said she’s heard of patients being turned away without testing despite displaying all the known clinical signs of COVID-19, including fever, cough, abdominal pain and shortness of breath. Shortages of personal protective equipment — or strict rationing — are also common at hospitals across the region, she said.
“I have a surgeon friend at Bon Secours who said he only gets a mask when he’s about to go into surgery,” she said. At her facility, full protective gear is reserved for providers caring directly for patients under investigation for COVID-19.
“And that’s just a handful of people,” she said. The shortages have led to widespread concern among the state’s medical providers, who are increasingly fearful of contracting the virus and unknowingly transmitting it to patients, family, or loved ones.
“It’s like sending a soldier to the battlefield without ammunition,” she said. “That’s what it feels like. A lot of us aren’t sleeping well at night. A lot of us are experiencing a sense of being scared for our lives for the first time.”
CDC tests faltered in Virginia
Current testing shortfalls are largely blamed on federal actions at the beginning of the coronavirus outbreak. The Centers for Disease Control and Prevention decided to design its own test for COVID-19 instead of using existing versions endorsed by the World Health Organization, said Dr. Donald Thea, a professor of global health at Boston University. Developing the test took weeks, but when the agency sent them out across the country, one of the components — a primer designed as a negative control — started giving false positives.
Virginia was one of the states where the test malfunctioned, said Denise Toney, director of the state laboratory. It took another few weeks for the FDA to approve the tests without the faulty component. The state lab then had to re-verify the accuracy of the test before it could independently process samples. Unprecedented demand for the components of the PCR test have also taxed the national supply chain, leading to backlogs and delays.
“One of our main limiting factors were the RNA extraction kits,” she said, one of several components required to assemble a working test. There are also nationwide shortages of flocked swabs and the transport media used to stabilize samples. All of those materials are required to build a working test, but the CDC often delivers them in fits and starts — a box of extraction kits one week, for example, and primers the next.
“We have to order every single one of those things separately, and we sometimes receive certain things in different quantities,” Toney said. The state recently began sourcing some testing components from private lab companies, and can now confirm test results with a single sample, increasing the overall capacity. Toney said the state lab is also developing its own test with different reagents than ones used by the CDC, which could make it easier to source materials.
She also said that the state began assessing its own stockpile of testing materials in February — early into the U.S. outbreak — and was quick to pivot when it became clear there were issues with the CDC test. It would have been difficult to begin stockpiling materials sooner, Toney added, especially when the outbreak began so far away.
“It’s a fine line to walk because these reagents are expensive,” she said. “And you don’t want to waste resources on something that started in China and might never come to the U.S.”
Thea wasn’t as willing to let individual states, including Virginia, off the hook. Yes, reagents and other testing materials are expensive, he said. But epidemiologists have been warning state and federal officials about the possibility of a widespread pandemic since the early 2000s, when there was a global scare over avian flu (Virginia has its own pandemic influenza plan that dates back to the same period). He also pointed to governments that have been able to successfully contain COVID-19 by rapidly scaling up testing, including Singapore and South Korea.
“They could have done it and they should have done it,” he said, referring to building up testing capacity. “Just look at South Korea.”
There are also ways the state could strategically deploy its limited supply of testing. Colorado recently announced it was distributing kits to specific areas where there hasn’t been widespread testing — an effort to learn more about how the disease is spreading.
Virginia could try something similar by dedicating some of its resources to randomized testing, which would give officials a better idea of whether the disease is spreading asymptomatically, said Madhav Marathe, director of the Network Systems Science and Advanced Computing Division at the Biocomplexity Institute. There’s growing evidence that people with mild to no symptoms are passing the virus to others at higher rates than originally suspected.
“We want to get a sense of the total number of infections rather than the confirmed number of infections,” he said. That knowledge could lead to better policy decisions on the part of state leaders. If a high number of people are asymptomatic, the state might want to consider stricter social isolation measures to prevent the spread of disease. If the number is lower than expected, the state could loosen restrictions it’s already put in place, which will continue to have a social and economic impact.
“The number of infected people will also tell us how many people will be hospitalized in the next few weeks” Marathe said. “If more people are infected, we can expect that number to go up quite rapidly.”
Private labs add testing capacity, but results take longer
More tests are slowly coming online in Virginia, including an independently verified test at UVA that can test up to 20 patients a day. Hospitals across the state are sending more and more samples to independent labs, which offer more flexibility than the state’s current guidelines.
“Physicians can use their clinical judgment instead of going through VDH, which is still only going to test the most high-risk patients,” said Dr. Joel Bundy, the chief quality and safety officer for Sentara Healthcare. Toney said the state lab is currently running between 50 to 80 coronavirus tests a day — though its capacity is more — based on the number of people approved by the agency for testing.
Private labs aren’t always a perfect solution. The average turnaround time for results is still between four and five days. State labs, on the other hand, can generally process samples within a few hours. Thea said it could be “infuriating” to rely on private labs, knowing that while results were pending, patients were forced to remain isolated and doctors were sometimes wasting protective gear on cases that turned out to be negative.
Also, state officials have said they don’t know how much testing capacity exists at private labs.
“We don’t have that information,” Peake said Thursday. “There’s no requirement for private labs to let us know what their capacity is. We have had conversations with them to try to understand what quantity they have but it is changing. New labs continue to be developed and so it’s not something we have a firm number on.”
Sentara, which largely depends on private lab companies for testing, was forced to suspend drive-through testing Wednesday due to “limited supplies.” The locations reopened the next day, but the health system said they would be kept open on a day-to-day basis as supplies allow.
Many hospitals in Virginia are also still hewing to the state’s testing criteria, or adopting even stricter guidelines, said the Richmond-area doctor.
The most recent guidelines from the Bon Secours Richmond Health System limit testing to health care providers with known exposure to a lab-verified case of COVID-19 or hospitalized patients in one of three categories: those in negative pressure rooms, those in designated respiratory units, or those admitted to the ICU with high suspicion of the disease.
It does little to assure health workers that they won’t be exposed to the virus.
“It’s like shooting fish in a barrel,” she said. “We’re such easy targets for this.”