How test kit shortages have hampered coronavirus containment efforts

The World Health Organization on Wednesday deemed the coronavirus a pandemic, a disease that has become widespread worldwide.

"We are deeply concerned both by the alarming levels of spread and severity and by the alarming levels of inaction. We have therefore made the assessment that COVID-19 can be characterized as a pandemic," WHO Director General Tedros Adhanom Ghebreyesus said. "This is the first pandemic caused by a coronavirus. And we have never before seen a pandemic that can be controlled at the same time."

More cases and deaths are expected outside of China and more countries will be reporting the virus, he said.

President Donald Trump on Wednesday night announced the suspension of all travel from Europe to the U.S. for the next 30 days, with the exception of the U.K. He also said emergency action would be taken to help individuals and small businesses financially hit by the coronavirus.

In China, where the virus began, the number of cases has relatively stabilized from when the coronavirus was first reported in December. COVID-19 is now spreading in Europe, Iran, Korea and elsewhere, including the U.S., where numbers top 1,000 cases and 29 deaths, not including Americans infected who were aboard the Diamond Princess Cruise Ship, according to Johns Hopkins figures.

The U.S is still in the beginning stages of the infection's spread, according to experts interviewed.

If the U.S. experience mirrors that of China, COVID-19 will run a course of about 10 weeks, according to Dr. Jeff Engel, executive director for the Council of State and Territorial Epidemiologists in Atlanta.

Asked what week we were now in, Engel said, "Week one."

To isolate individuals with the disease, China built hospitals and converted others, with patients who needed other types of care getting treatment through telehealth.

The U.S. is following similar guidelines for telehealth, but isolation has mostly been left to individuals to self-quarantine at home.

As recently as two weeks ago, on February 25, Health and Human Services Secretary Alex Azar said the number of cases was holding steady at 14, not including Americans repatriated from Wuhan and aboard the Diamond Princess cruise ship.

But unlike China, where the disease had an epicenter in Wuhan, in the U.S COVID-19 cases were originally concentrated in Washington State and California, but the disease was and continues to come into the country from infected areas as well as through community spread.

China put the city of Wuhan under quarantine. In the U.S., the city of New Rochelle, New York, 20 miles north of New York City, is marked by a one-mile containment zone due to a large outbreak of cases there. But for much of the country, there is no single containment area.

"What you can do in China and what you can do in the United States are two different things," said Dr. Alfred Sacchetti, spokesperson for American College of Emergency Physicians and chairman of Emergency Medicine at Our Lady of Lourdes in Camden, New Jersey. "In terms of whether somebody self-isolates, we're not a country that can forcibly isolate someone. We don't have enough hospital space to isolate people. We have to prepare for people going home and self-isolating. It's going to spread. You'd like to minimize it. Epidemiologists say there is no way to control a virus this contagious."

Engel said that early on, there was an attempt at containment for people who tested positive. But for those with a mild illness, there was never an intent to hospitalize them to keep them isolated. Even in the beginning, they were told to go home and self-isolate.

"It's always a balance," Engel said. "Often we trust Americans to do the right thing. That's obviously not always the case."

TEST-KIT 'FIASCO'

Hampering efforts has been a shortage of test kits. The first batch from the Centers of Disease Control and Prevention was found to be defective. Some of the controls in the original test were behaving in an erratic way.

This has left hospitals and labs without an adequate supply for the past two weeks.

"The fiasco with lab testing, the initial failure of the test, set us behind weeks," Engel said.

Beyond being able to have a diagnosis for the patient and family, testing is a valuable tool in prognosis.

"I'm a medical doctor too," Engel said. "It's extremely valuable for public health purposes. We have to know, at least in the early phases in the community, where people are getting sick. Once identified by a lab test, we can interview the person or family."

If there is no known travel outside of the country, officials can determine where the community spread is occurring.

Test kit production is being ramped up. Vice President Mike Pence, who is coordinating and heading the nation's coronavirus efforts, promises four million test kits by the end of this week.

At first, the only validated test came through the CDC. It developed a kit to deploy to the state health departments. Some commercial labs are getting up and running, such as Quest Diagnostics. Hospitals such as Massachusetts General are developing their own test, and Amazon and the Gates Foundation are reportedly teaming up to deliver test kits to homes in the Seattle area.

But the past two weeks represented a critical time to be without the supply of needed tests, as the number of cases has climbed.

"It certainly interfered with our containment strategy. It was a critical two weeks that we lost," Sacchetti said. "Identifying the virus does make a difference. We get a better understanding of the biology of the disease."

For patients who suspect they have the disease, but who have been unable to get tested, getting a positive test result will let them know whether they have coronavirus, and could determine their actions as far as self-isolating themselves and their family, but it doesn't help them with treatment, Sacchetti said.

"If you have a treatment for a disease and have a test to identify the disease, that's important," Sacchetti said. "If I have a disease I don't have a treatment for it, then it doesn't matter if I have the test. Unfortunately, the coronavirus falls into that category."

Individuals with mild symptoms are sent home to self-quarantine, whether they are tested or not. Only those sick enough to be hospitalized are moved into a respiratory isolation room.

Hospital staff are using personal protective equipment for anyone who comes in with a respiratory complaint.

"The assumption is, from the staff's standpoint, you have the coronavirus," Sacchetti said. "More rapid testing would be nice. For the individual patient directly in front of you, they will be managed symptomatically."

Emergency rooms could always use more resources, including more access to testing and more personal protection equipment, Sacchetti said.

The test kit availability has been somewhat limiting, said Dr. David Hooper, chief of the Infection Control Unit and associate chief of the Division of Infectious Diseases for Massachusetts General Hospital.

Hooper has been on the front lines of testing. Seventy of the 92 coronavirus cases in Massachusetts are linked to a Biogen conference in Boston held at the end of February. The conference included attendees from Italy who returned home positive with the disease.

Massachusetts General Hospital in Boston and Brigham and Women's Hospital, which are both part of the larger Mass General Brigham, with help from the Department of Public Health, each tested roughly 80 people, according to Hooper. None needed hospitalization and they were sent home.

The hospitals were able to set that up within a couple of days. They sent sampling to the state lab.

But Mass General is "working hard to get up and running our versions of diagnostic tests for this virus with emergency use authorization they've said they will now allow," Hooper said of the CDC. The hope is that this will be brought online within a couple of weeks.

"The challenge is when everybody wants to do something at the same time," he said. "We had several cases where it was three or four days from a sample to the result."

The state lab turnaround can be as soon as one day, and they've had an influx of people to be tested, he said. But getting a diagnostic result from a test done in-house can be done in a matter of hours.

Testing is only for those who are symptomatic or have risk factors such as recent travel or contact with an infected person. 

WHAT TO EXPECT

Coronavirus Infection is more contagious than the flu, and more deadly.

COVID-19 is ten times more lethal than the seasonal flu, according to Dr. Anthony Fauci, director of the national Institute of Allergy and Infectious Diseases. The flu has a 0.1% mortality rate, compared to at least 3% for coronavirus, looking at 121,250 cases worldwide, and 4,369 deaths.

Those most vulnerable are individuals aged 80 and older and people 60 and over who have a comorbidity.

Engel and his colleagues believe the coronavirus will roll through like an influenza wave for six to 10 weeks across the country, before it dies out, as does influenza each season.

"We don't know if it will be a permanent fixture in the human condition," he said. "We think this is going to be a wave of disease like an influenza wave."

The biggest way to control the wave is to cancel large events, which is happening nationwide.

Some areas, such as in Washington State, have begun closing schools and numerous companies are asking employees to work from home.

"Social distancing can do a lot to blunt the wave," Engel said.

Hooper agreed, saying, "You really have to focus on having the population do standard public health stuff such as social distancing, staying at home if you have symptoms. There has to be a realization that public health measures are the way to get this under control."

This is the third coronavirus in the past 15 years. One, SARS went away; MERS is relatively contained in the Middle East.

Engel said his crystal ball shows the virus will go away for the summer, if COVID-19 behaves as the others, spreading better in cold, dry air. By summer, people, and in particular children, will not be clustered together in buildings.

Hooper said, "I don't know if we're week one here. We're anticipating this going on for a number of weeks. Whether there's a seasonality to this virus, nobody knows."

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com