Private sector hops on COVID-19 testing as the nation lags behind

Blood sample tube positive with COVID-19 or novel coronavirus found in Wuhan, China, 2019. Photo by jarun011.

By Yun Hao
Medill Reports

After President Trump declared a national emergency Friday due to the COVID-19 pandemic, representatives of Roche Diagnostics, Quest Diagnostics, LabCorp, Walmart, Target, Walgreens, CVS, and some other private sector companies stood together behind the president, and each addressed their decisions of confronting the coronavirus collaboratively.

Normally you view us as competitors, but today we’re focused on a common competitor, and that’s defeating the spread of coronavirus,” said Brian Cornell, CEO of Target Corp., during the press conference held by the President. “We look forward to work with the administration to do our fair share to alleviate this growing threat.”

FDA also sped up its approval process for tests developed by commercial labs. Roche Diagnostics, a Swiss-based multinational healthcare company, was the first beneficiary, as the test method they developed was approved within only “a few hours” after they submitted their application. Dr. Deborah L. Birx, U.S. Special Representative for Global Health Diplomacy, said that this expedited process sets a “record time.”

But testing kits remain somewhat  limited for now, after weeks of delay that has impeded an accurate confirmation of the severity and spread of COVID-19 in the leading industrial economy in the world.

Here’s what’s happening. We’re not getting enough tests,” Illinois Gov. J.B. Pritzker said, and he didn’t hide his frustration when being asked about the supply of the novel coronavirus testing kits during the March 11 Illinois COVID-19 press briefing. The national emergency was declared two days later.

As you know, I’ve been very vocal on this subject.” Gov. Pritzker said. “Yesterday, I put in calls to people, at the federal government level too, and I made sure they understood what my call was about. And I got no return phone call from at least two major officials that I reached out to. Now, I know they’re busy. And, you know, I often have heard, well, someone’s in the situation room, or someone’s in an important meeting, and they can’t call the governor of Illinois back on this subject.”

Illinois joined New York City, Minnesota, Wisconsin, Arizona and many more states and regions pleading for more tests amid a nationwide test kit shortage.

Why do we say that the U.S. lagged behind on testing?

The United States is closely compared to South Korea when it comes to the testing scales. The two countries both confirmed their first case on Jan. 20 and two months later, South Korea with a population of 51 million is performing more than 18,000 tests a day, while the highest record for the United States as of March 16 is a little more than 2,700.

The U.S. has a population of almost 6.5 times that of South Korea and performed 19,744 tests total, with the combined efforts of CDC (Centers for Disease Control and Prevention) labs and U.S. public health labs from Jan.18 to March 15. Judging from the fact that South Korea ran 17,997 tests on March  4, and 18,177 on March  6, it will take the country a little more than a day to finish all the tests that U.S. has performed in the past two months.

Among the most affected regions that disclosed their cumulative tests, Japan is the only nation that had ran fewer tests in the past two months than the U.S. But taking population into consideration, Japan with less than half of the U.S. population had performed 103 tests per million people while the U.S. had completed an estimated 59 per million as of March 15.

Yet testing is not the only area where that the U.S. is lagging behind. CDC’s ability to update the number of confirmed cases also caused concern. Even though few countries are as efficient as South Korea when it comes to the testing speed, most countries including China, which is notorious for its controls on information disclosure, are able to update their information pages at least once a day.

As KCDC (Korea Centers for Disease Control & Prevention) was updating data sets twice a day once confirmed cases in South Korea surpassed 30 on Feb. 20, CDC in the U.S. today still has a lag of four days when it comes to the number of confirmed cases and the number of tests performed. As shown in Chart 1, we still do not know how many tests were run nationwide on March 12, 13, 14, and 15. And this is already after one round of improvement.

Looking back a few days, journalist Judd Legum of Popular Information tweeted on March 2 that he found CDC “has stopped disclosing the number of Americans tested for coronavirus”, and that he considered this a “coverup” for the incompetence of testing.

Wisconsin Democratic Congressman Mark Pocan wrote a letter of complaint to the federal agency on the same day urging the CDC to provide daily updates instead of the original frequency of only three times a week. CDC  Director Dr. Robert R. Redfield agreed on Mar. 10, during a House Appropriations Committee hearing and promised more clearly-structured daily disclosure, but reported figures are still lagging behind.

Why does this number matter?

In fact, the number of tests performed each day is not seen as a significant number to disclose in many countries. Health departments of countries including China, France, Iran, Spain do not publish this figure and are not blamed for this. So why did it become such a big deal when U.S. CDC deleted that role of data on their websites?

First of all, even though the above countries do not update their data of tests performed and their testing capacity, it doesn’t mean that they do not know or that they can’t do so. All these countries are updating statistics of nationwide newly confirmed cases, deaths, the number who recovered, and the breakdown by region on a daily basis, while CDC still wasn’t reporting timely figures as of Mar. 17 on how many cases are confirmed each day, which should have been the most important number.

Moreover, the situation can be very confusing here because U.S. officials and leaders had been sending out completely different messages.

During President Donald Trump’s visit to CDC in Atlanta on Mar. 7, he said, “Anybody, right now and yesterday, everybody that needs a test gets a test… They’re there, they have the tests, the tests are beautiful.” President Trump repeated similar statements at least three times that day, indicating that the nation had enough test kits for every individual that needed a test.

But shortly after, Vice President Mike Pence presented another picture during his own press briefing as leader of the White House coronavirus task force. “We trust in a matter of weeks, the coronavirus tests will be broadly available to any American that is symptomatic and has the concern about the possibility of having contracted the coronavirus.

Three days later on Mar. 10, former FDA Chief Scott Gottlieb and Connecticut Democratic Congressman Jim Himes started to endorse estimated data published by the American Enterprise Institute, a public policy think tank, claiming that the country now has the capacity to test 16,000 people each day, while the nation was only testing 2,500 to 2,700 people a day, according to CDC’s statistics.

The U.S. enjoys the most developed healthcare facilities and laboratories in the world and testing capacity of 16,000 people should be feasible. But FDA Commissioner Stephen Hahn could not give out a clear answer as to whether the country can perform that number of tests per day when questioned by Pocan on Mar. 11, nine days after he announced on Mar. 2 an estimate that, by Mar.8, “close to a million tests will be able to be performed” during a White House press briefing on Mar.2.

Why are we seeing these problems and what should we expect?

“This is a result of the CDC having made a decision early on to not let the best research hospitals and institutions around the United States develop their own tests,” said Gov. Pritzker during the Mar.11 press briefing. “They’re now loosening that up because they realized they created a problem. But as a result of the early decision, there was dependence upon this one reagent. This one test method.”

There was just one producer of this reagent approved for testing, according to Pritzker.

Doors for commercial labs were finally opened on Mar.3, according to Dr. Birx. She said that President Trump realized the previous testing model could not meet the demand. The White House then invited Quest Diagnostics and LabCorp to help with the situation.

“We’re ramping up our capabilities at other laboratories and expect to be able to perform tens of thousands of tests within the next few weeks,” said Rachel Carr, a specialist from Quest Diagnostics. The company’s labs in San Juan had just started testing on Mar.9, and by the end of this month, they are expecting to expand the testing labs to several major cities across the nation including Chicago.

According to the ACLA, American Clinical Laboratory Association, “once additional FDA-approved high-throughput testing is available on large diagnostic platforms next week, the industry expects its capacity to be increased to more than 20,000 tests per day. Assuming there are no delays or shortages of necessary materials and supplies, commercial capacity is expected to exceed 280,000 tests per week by April 1.”

For now, with the limited testing kits available, not every patient with symptoms demanding a test can expect to get a test. All patients with symptoms are required to call their doctors instead of walking into any medical infrastructure to avoid exposure of health care workers and people in the waiting room. Health care providers will follow the guidelines of CDC and determine whether their patients should get a test.

In Illinois, Dr. Ngozi Ezike, Director of Illinois Department of Public Health, called upon the ones with mild symptoms not to demand testing, as the state needs to prioritize people “at the highest risk of illness.” She gave high priority to:

– people with advanced age;
– people residing in long-term care facilities;
– people with preexisting medical conditions like heart disease, lung disease, hemodialysis, liver disease, or who otherwise have  compromised immune systems.

But if the test kits  become available as estimated, people can expect a much easier way of testing. Instead of visiting health care providers’ offices, people will be able to experience “drive-thru,” a procedure that is underway in the Chicago area with an order from their physician.

This method of specimen collecting is used by South Korea and is believed to be one of the reasons why it can perform 18,000 tests in one day. According to President Trump, Walmart was asked to make portions of their parking lots available for the drive-thru tests, and Google had been working on developing an app with which users can search locations for drive-thru COVID-19 tests.

Photo at top: Blood sample tube positive with COVID-19 or novel coronavirus found in Wuhan, China, 2019. (Photo by jarun011, Getty iStockphoto)