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States Not Hitting Testing Goals; Feds Promise Aid

May 14, 2020 -- Getting a diagnostic test for the coronavirus is now easier than when the pandemic first started. There are fewer restrictions on who gets tested and more places to get tested.

Places such as Los Angeles are providing free testing to any resident who wants it, and in many states, health officials are urging anyone who wants a test to get one. It is all a shift from limiting tests to people with symptoms, people in high-risk categories such as those over 65, those with health conditions, or front-line health care workers.“There is more testing capacity across all states. Even a month ago, people would show up with classic symptoms with COVID-19 and be told to go home and self-isolate. Now, at my hospital, when anyone comes in with any symptoms, they can get tested, the guidelines are different than a month ago,” says Ingrid Katz, MD, associate faculty director of Harvard University’s Global Health Institute and an associate physician at Brigham and Women’s Hospital in Boston.

Rapid diagnostic tests have also improved the turnaround time for results. Brigham and Women’s has its own microbiology lab that can produce test results in a few hours. Medical device manufacturer Abbott is producing ID NOW COVID-19 “point-of-care” tests and devices for commercial and public health laboratories that diagnose COVID-19 where and when patients are tested and produce results in less than 13 minutes.

Despite the developments, one recent Harvard study found that fewer than 10 states have done enough testing to safely reopen. But more communities have testing sites now than they did in March. Nearly every state has a drive-thru testing site, and 33 states offer testing through major drugstores in 240 locations, Assistant Secretary for Health Brett P. Giroir, MD, said at a May 12 Senate hearing on COVID-19.

Widespread Testing Needed

While progress has been made, top health officials and public health experts agree that more widespread testing for infected patients is the key to reopening society.

To date, more than 9 million tests have been done nationwide. The federal government, working with state officials, has set a national goal of reaching 12.9 million tests in the next 4 weeks, Giroir told senators. While the U.S. leads the world in the number of tests performed, it trails at least 30 other countries for the number of tests done per each million people, according to a statistics tracking website.

Testing is a vital part of any pandemic fight, says Eduardo Sanchez, MD, chief medical officer for prevention at the American Heart Association and a former Texas state health commissioner.

“It's crucial of course to help treat, isolate or hospitalize people who are infected,” he wrote in a column on the association’s website. “Testing also is important in the bigger public health picture on mitigation efforts, helping investigators characterize the prevalence, spread and contagiousness of the disease.”

It also provides important information for our future, he said.

“When we look back at what will be the first wave of COVID-19 in the United States, testing data will help us develop a full picture of the epidemiology and course of this disease,” Sanchez said. “The data can provide important puzzle pieces for stopping or slowing the disease in the future.”

Giroir, meanwhile, told senators he estimates that the nation would be able to do 40 million to 50 million tests in the fall, “taking every aspect of development, authorization, manufacturing, and supply chain into consideration.”

Meanwhile, Ashish Jha, MD, a director at Harvard’s Global Health Institute, told the House Select Subcommittee on the Coronavirus Crisis on Wednesday that the nation needs to be doing 900,000 tests daily for states to safely reopen. The current daily testing number is about 300,000 total.

“It is critical that the federal government set appropriate targets for testing and communicate those targets. For months, the administration has been saying we have enough tests when we don’t. This has sent a signal to markets against investing in additional capacity and new testing capabilities -- at precisely the moment when these investments are most needed,” he said in his prepared statement to the committee.

Jha called on the federal government to do more to increase testing, support states to reach their testing targets, and to encourage innovative new tests to identify those who are positive for COVID-19.

State Report Cards

Jha and his team of researchers analyzed each state’s testing data and projected the number needed given the size of each state’s outbreak. The Harvard analysis found that 41 states and the District of Columbia are not doing enough testing to safely reopen.

Only nine states are close to reaching or have exceeded the daily testing targets: Alaska, Hawaii, Montana, North Dakota, Oregon, Tennessee, Utah, West Virginia, and Wyoming.

These states, with the exception of Oregon, have already begun reopening. But, other states including Georgia, Texas, and Colorado, also partially reopened despite being far from reaching their targets, says Katz. “As things shift more, they will only fall further behind.”

Georgia currently averages 8,600 tests per day -- far fewer than the estimated 25,979 tests Harvard researchers say are needed by May 15. Colorado averages 2,361 tests per day, also far fewer than the minimum 22,942 tests needed daily, and Texas averages 17,735 tests per day, falling about 10,000 tests short of the minimum needed daily, according to the institute’s state calculator. Katz cautioned that these are snapshots, and that as states open, things will change.

In contrast, several states with large outbreaks that have a way to go with testing are still shut down, including Massachusetts, Connecticut, and New York, says Katz.

Supply Chain Barrier to Testing

State officials say they would like to increase testing but complain about the lack of federal assistance and coordination with ongoing supply chain issues.

“The delivery of supplies is a critical issue. The logistics of getting this out, whether it’s PPE [personal protective equipment], testing, or medical equipment, is extremely fragmented, leading to price gouging and many other inefficiencies. You need to stand up the full power” of the Defense Production Act, U.S. Sen. Tammy Baldwin, D-WI, a member of the Senate Health, Education, Labor and Pensions Committee, said at Tuesday’s hearing.

There have been shortages of nasal swabs, collection devices, and transport media that are needed to take, collect, and transport patient samples to labs for testing, according to Eric Blank, DrPH, chief program officer at the Association of Public Health Laboratories.The association represents state and local governmental health laboratories in the United States.

There have also been shortages of “reagents,” which are the supplies laboratories need to run the tests including the chemicals needed to extract RNA from the patient’s sample. “The extraction kits were the biggest challenge early on,” says Blank. 

The U.S. was competing with countries in Europe and Asia for these reagents in February when they were also increasing testing. “There was a global demand for reagents -- that put everyone and the U.S. behind,” says Blank.

But he is cautiously optimistic that the supply chain bottlenecks are being resolved, given the federal government’s increasing role.

Giroir reassured senators at Tuesday’s hearing that states will receive 12.9 million swabs and 9.7 million tubes of media this month. The federal government will also acquire more than 135 million swabs and 132 million media tubes and distribute them to states until the end of this year.

“For the swabs and media, there is a non-mature industry in the U.S., which is why we made the decision to procure those centrally. There are too many companies to control without a federal hand,” Giroir says.

He also announced that the FDA just approved its first COVID-19 rapid “point of care” antigen test. The manufacturer, Quidel, “anticipates being able to distribute 300,000 tests daily in the next few weeks,” says Giroir.

WebMD Health News Reviewed by Brunilda Nazario, MD on May 14, 2020

Sources

Assistant Secretary for Health Brett P. Giroir, MD

Ingrid Katz, MD, associate faculty director, Harvard University’s Global Health Institute; associate physician, Brigham and Women’s Hospital, Boston.

Eric Blank, DrPH, chief program officer, Association of Public Health Laboratories.

Senate COVID-19 Hearing, 5/12.

HHS.gov: “HHS Supports State, Territorial and Tribal Public Health Labs with COVID-19 Rapid Point of Care Test.”

Senate Health, Education, Labor and Pensions Committee.

Pandemics Explained: “HGHI and NPR publish new state testing targets.”

Association of Public Health Laboratories: “General Consulting.”

The Washington Post: What I Learned Taking the Free Coronavirus Test Offered to Everyone in Los Angeles.”

 The New York Times: “See Which States Are Reopening and Which Are Still Shut Down.”

NPR.org: “U.S. Coronavirus Testing Still Falls Short. How's Your State Doing?”

The Covid Tracking Project.

FierceBiotech: “FDA greenlights its first coronavirus antigen test for rapid point-of-care screening.”

American Heart Association: “COVID-19 science: Why testing is so important.”

Worldometers.info: “Reported Cases and Deaths by Country, Territory, or Conveyance.”

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