What’s behind the COVID-19 testing bottleneck

DOUG QUATTROCHI traveled to New York as the coronavirus outbreak was beginning there, then came home to Worcester and developed a fever and shortness of breath. His doctors ruled out pneumonia and the flu, but would not test for COVID-19 because he could not demonstrate that he had contact with a person known to be infected.

Quattrochi was walking around for several days until CareWell Urgent Care agreed to take a swab, though they could not guarantee it would get tested. He shared food with a senior and attended an event at Boston Symphony Hall before he self-quarantined, still not knowing whether he was infected or not.

“It seems to me the public response is really flawed,” Quattrochi said. “I’ve got to believe there’s a lot of people who have potentially been exposed and somehow we have no clue.”

As the number of coronavirus cases rises in Massachusetts and individuals languish in self-quarantine, kits to test for the illness remain scarce, leading to concerns among some providers and patients that infected people are walking around exposing others. Protocols have been established limiting who can be tested and only one lab in Boston, operated by the Department of Public Health, is authorized to conduct the tests, creating a bureaucratic backlog that is time consuming and cumbersome. One hospital has started sending swabs to a lab in California, while another is using couriers – and sometimes even its own infectious disease head – to transport samples from the Berkshires to Boston.

The scarcity of testing in Massachusetts mirrors what is happening throughout the country, as officials nationwide say they do not have enough testing capability. Vice President Mike Pence has acknowledged a shortage, despite conflicting statements from President Trump and his top health officials. Even as testing capability has begun to expand from just the US Centers for Disease Control and Prevention into state and private labs, the CDC continues to maintain strict guidelines around who is eligible to be tested.

The problem is particularly acute in Massachusetts, which had 108 documented cases of COVID-19 as of mid-afternoon Thursday, the fourth-most in the US after Washington, New York, and California. That is up from 95 Thursday morning.

“The 95 cases we have–that’s where Italy was at two weeks ago,” said Sam Scarpino, an assistant professor of network science who heads the epidemics lab at Northeastern University. “They have 12,000 cases as of this morning, and their hospitals are overrun.”

Limited eligibility for testing

With testing resources scarce, the Centers for Disease Control has set strict eligibility guidelines for who can get tested, which the state Department of Public Health is relying on.

The CDC recommends testing people who have traveled to countries with known cases and who have had contact with individuals with confirmed cases, including health care workers. It also recommends looking for certain symptoms, including fever and shortness of breath.

But those are just recommendations, and discretion has been left in the hands of providers and then the state’s epidemiologists.

Dr. Shira Doron, an infectious disease physician and hospital epidemiologist at Tufts Medical Center, said if a doctor thinks a patient should be tested – and the hospital’s team of infectious disease specialists agrees – the hospital will call the state epidemiologist and leave a message. It could take up to four hours for the epidemiologist to return the call and approve the test or not. Test results take one to four days to come back.

During that time, Doron says, the patient is in isolation “waiting for results and anxious.” For inpatients, hospital staff are using up protective equipment like masks, possibly unnecessarily.

Some individuals who meet the strict criteria say they have gotten tested quickly.

North Adams city councilor Jason LaForest, a nurse, was told Monday evening that he sat near a person with coronavirus at a meeting. He woke up on Tuesday with a cough, sore throat, and mild headache. He told the state Department of Public Health, and a few hours later was instructed to drive to the emergency room in North Adams for testing. His test came back Thursday as negative.

A local community leader in the Boston area, who asked that his name be withheld, returned from a national convention in Washington with flu-like symptoms and was told days later that a friend there, who the man hugged and talked to, tested positive. The man told his doctor, who called a hospital review board, and received approval for testing, which came back negative.

But several doctors have complained in Facebook posts or in public interviews that they do not believe the state is allowing enough people to be tested. Monique Aurora Tello, a doctor at Massachusetts General Hospital, said in a Facebook post that she saw eight patients Thursday morning with probable coronavirus who had traveled on buses and planes.

“The state wouldn’t let us test them all. Not enough tests!!” she said.

A shortage of labs

The test for COVID-19 involves taking one swab from a patient’s throat and another one through the nostril into the back of their throat. This is done at providers’ offices and at hospitals and sent to the state lab.

Hospitals are also still developing ways to take swab samples without jeopardizing their staff. While some hospitals, like Tufts, take the swab in a clinic or hospital setting, others, such as Brigham and Women’s Hospital, are conducting “drive-through” testing in an ambulance bay.

Processing the swab involves a polymerase chain reaction test, a method that lets scientists test for viral genetic material. Test kits have been doled out slowly by the CDC, with some in the medical field chalking the delays up to bureaucracy and others blaming it on a shortage of the materials needed to process the tests.

The other big problem is the state’s limited capacity to conduct the tests. Currently, the State Public Health Lab in Boston is the only lab in Massachusetts approved by the US Food and Drug Administration to test patient swabs. The lab is operating around the clock, but still having problems keeping up.

According to Ann Scales, spokeswoman for the Department of Public Health, the test is a manual process that involves “a lot of staff time and effort.” A recent shift to automating the process quadrupled the state lab’s testing capacity — but only from around 50 tests a day to 200.

Although DPH says results should be available within 24 hours, multiple hospital officials said the turnaround time can be anywhere from one to four days.

After a meeting with officials from Berkshire County in Pittsfield, Gov. Charlie Baker said the state lab now has the capacity to do an additional 5,000 tests, on top of the several thousand it was already capable of doing. But Baker said the state desperately needs more testing capability, and the key to expanding testing is federal approval for private labs and hospitals to conduct tests on their own.

“This is among our highest priorities,” said Baker, who has mentioned it several times this week. “This is a critical issue for us.”

North Adams Rep. John Barrett III said getting new testing sites approved, particularly in Western Massachusetts, is a “no-brainer.” “This is no time to fool around with regulatory bureaucracy,” Barrett said.

Quest Diagnostics, a Fortune 500 company based in New Jersey, launched its own COVID-19 test on March 9, and the company says providers anywhere in the US are now able to order it. But the Quest test has not been approved by the Food and Drug Administration, so a positive test from Quest must then be confirmed by a government-run lab.

If Quest test wins FDA approval, company spokeswoman Rachel Carr said the company aims to begin operating “high complexity laboratories,” one of which will be in Marlboro, Massachusetts, within two weeks.

LabCorp, a North Carolina company that operates clinical laboratories, began offering its own test to physicians March 10, but that test is also awaiting FDA approval.

That leaves Massachusetts hospitals, many of whom are awaiting federal approval to launch their own testing operations, searching for fast and accurate labs.

UMass Medical Center in Worcester is using the state lab, but if DPH does not approve running a test, the center will in some instances send the swab to Quest Diagnostics in California. In the last two days, UMass Memorial has sent 20 samples to Quest and none to the state lab.

Kimiyoshi Kobayashi, the hospital’s chief quality officer, said UMass Medical will “definitely” want to use Quest’s Marlboro lab rather than taking swabs to the airport each day to fly them to California, then waiting three to four days for results. “It’ll reduce turnaround time,” Kobayashi said. “It would be ideal if we could test patients quickly and in an efficient manner.”

Many hospitals are still relying on the state lab – a process that can be cumbersome and inconvenient.

“Our infectious disease director has literally driven samples to Boston,” said Michael Leary, a spokesman for Berkshire Health System, which oversees Berkshire Medical Center and Fairview Hospital in Great Barrington. The hospital is now using a courier to deliver swabs and is investigating whether it can conduct tests at Berkshire Medical Center.

Doron, the Tufts epidemiologist, said the hospital is considering using its own lab or a private lab. “We want to move away from having to call the state health department about every possible case, with all of the slowdowns and throughput that entails,” she said.

But Doron said it is often not that simple. In addition to needing federal approval, there is a shortage of the materials needed to process the tests, some labs are not set up to provide 24-hour notifications of test results, and there is the question of who will pay.

Massachusetts General Hospital is considering sending tests to LabCorp in California and is also working to develop an in-house test to avoid the three to four-day turnaround time at the state lab. “The state lab has a lot in its line of requests for testing. It’s been a challenge,” said David Hooper, chief of the infection control unit at the hospital. But Hooper said getting in-house test kits approved by the FDA requires proof that other means of state testing, like the state lab, are swamped.

The testing debate

Most people in the medical community believe more testing is desperately needed, but some are beginning to wonder whether the disease has already progressed beyond the testing phase.

Doron of Tufts said with no treatment available and cases already spreading throughout the community, it may become impossible to isolate everyone with the illness. There may then be little benefit to widespread testing of people with mild symptoms, other than for research purposes to establish the prevalence of the disease. She noted that the general recommendations are the same for someone with any respiratory illness – practice good hygiene and stay home.

But others say testing is an effective tool in dealing with the growing number of patients.

“We’re not running nearly enough tests, and we don’t have a great sense of how many cases we’re missing,” said Scarpino of Northeastern University.

South Korea is running 15,000 COVID-19 tests a day, while the output in Massachusetts is 200 a day, and that’s with a recent improvement that quadrupled the capacity. “We’re off by a factor of a thousand for the number of tests we need,” Scarpino said.

Update: The Department of Public Health said, after this story was published, that Quest and LabCorp have begun testing in Massachusetts, and one of those labs reported its first presumptive positive case to the state lab on Thursday.