The White House is under enormous pressure to dramatically increase the nation’s capability to produce tests to control the coronavirus outbreak and safely reopen an economy shuttered by the pandemic.
President TrumpDonald TrumpHillicon Valley — State Dept. employees targets of spyware Ohio Republican Party meeting ends abruptly over anti-DeWine protesters Jan. 6 panel faces new test as first witness pleads the Fifth MORE told reporters on March 6 during a visit to the Centers for Disease Control and Prevention in Atlanta that “anybody that wants a test can get a test,” but that has been far from the reality.
Expanded diagnostic testing will be an integral part of the effort to contain the coronavirus as blunt measures like stay-at-home orders are eased. But from supply chain issues to lab capacity and reimbursement, persistent problems will make restarting the economy a challenge.
Here are five things to know about where the U.S. stands on COVID-19 testing:
Diagnostic tests are increasing, but experts say far more are needed
Top administration officials on Monday said they expect the U.S. to have the capacity to conduct 2 million tests per week by the end of May. Testing capacity has significantly improved since the Centers for Disease Control and Prevention botched the rollout of its initial diagnostic test in February.
Only 5.6 million tests have been conducted — more than in other countries but less than what is needed given the size of the U.S. population.
Health experts say the 2 million per week figure undersells the number of tests really necessary to safely reopen the economy.
Harvard researchers said last week that at least 500,000 tests per day, or about 15 million tests per month, are needed.
Anthony FauciAnthony FauciThree omicron cases of COVID-19 identified in Maryland: Gov. Hogan FDA eyes rapid review for omicron vaccines, drugs: report Fauci calls out Fox News for letting host compare him to Nazi doctor: 'Astounded' MORE, the government’s top infectious disease expert, recently said the country’s needs are “closer to” 3 million tests per week, or about 12 million per month.
On Tuesday, Fauci acknowledged there have been problems with testing, but told CNN the country is moving in the right direction, and he hopes that “everyone who needs a test” will get one by the end of May or beginning of June.
The administration is relying on states to develop their own testing plans
The administration’s initial guidelines for reopening the economy explicitly left it to states to scale up their own testing systems, including antibody tests. There was no plan on how the federal government would provide support.
On Monday, the administration sought to fill in the blanks, and offered a new blueprint for states to scale up their testing in the coming weeks. States will need to develop their own testing plans and rapid response programs and will have to monitor for potential outbreaks “throughout the summer and beyond.”
The goal was to provide enough tests to all 50 states for at least 2 percent of their residents. But experts argued the guidelines will just let states tread water— most are already testing 2 percent of their residents and are struggling to ramp up capacity without federal help.
The White House plan made it clear that the federal government will serve as a coordinator between states and the private sector.
Supply chain shortages persist
A major consequence of the federal government stepping back from a leadership role has been a free-for-all among states seeking to acquire testing materials.
States have been competing against each other and the federal government for medical equipment and testing supplies like chemicals and swabs, which is driving up prices, eating up the time of state officials and creating a bottleneck that has hindered capacity.
State officials are tapping whatever resources they can find. Maryland Gov. Larry Hogan (R) used his wife’s connections to launch a secret plan to secure 500,000 diagnostic tests from South Korea.
Joshua Sharfstein, a former Food and Drug Administration official and a vice dean at the Johns Hopkins Bloomberg School of Public Health, said the federal government has been shirking its responsibilities.
“This is a once in a century challenge, but the federal government has not embraced its role,” Sharfstein said. “States and the labs themselves are having issues, and the failure of federal leaders is being felt.”
Scott Becker, CEO of the Association of Public Health Laboratories, said he agrees states should be in charge of their testing strategies, but the federal government still has an important role.
“The states are responsible for how the strategy will work in their state, but that is dependent upon an expanded and consistent supply chain, and that is really where the federal government comes in,” Becker said. “Sometimes it’s really just a phone call, but sometimes it’s the weight of the government coming in and expanding whatever is necessary.”
But the Trump administration’s blueprint on Monday said the federal government should only be a “supplier of last resort.”
Public and commercial labs say they need more sustained funding
Labs say they need federal funding to make the investments to increase the number of tests they can perform. The most recent coronavirus stimulus bill contained $25 billion for testing, with much of the money directed at states to increase the number of people they can screen.
The American Clinical Laboratory Association (ACLA), which represents commercial labs, has urged the administration to allocate a portion of that $25 billion to provide direct support to laboratories performing COVID-19 testing.
During a meeting with the White House coronavirus task force on Monday, ACLA officials praised steps the administration has taken, but said they need more support.
Commercial labs perform the majority of the testing, and if states are supposed to drastically increase testing capacity, labs will need to invest in more machines in addition to supplies like swabs and reagents.
Antibody testing is key, but many tests are flawed
Antibody testing is a diagnostic that can look at a person’s blood and see if there is evidence of prior infection. Scientists have been running large scale studies using antibody testing to determine the percentage of a state’s population that may have been exposed to the virus.
The goal is to identify people who may have immunity even if they have never been diagnosed. But questions have swirled around the accuracy of tests, and about what immunity really means.
A recent report from the House Oversight and Reform Committee found that the FDA allowed a flood of antibody tests on the market without review, resulting in hundreds of flawed tests that are still available for purchase.
In the rush to get antibody tests to the market, the FDA waived reviews and essentially let companies police themselves. To date, it has granted a formal authorization to just seven tests.
Rep. Raja KrishnamoorthiSubramanian (Raja) Raja KrishnamoorthiUS braces for omicron to hit Former Washington Football Team cheerleaders, employees to protest outside stadium Rapper Wale to headline Washington Football Team halftime show MORE (D-Ill.), chairman of the Oversight Subcommittee on Economic and Consumer Policy, told The Hill that the FDA has not committed to clearing the market of all the unauthorized tests.
“FDA is doubling down on their policies. It’s dangerous ... and we’re going to regret that,” Krishnamoorthi said. “If you have a test kit that gives you a false positive, that person might view it as a green light to engage with other people and relax social distancing, and a consequence is they’ll get sick and get others sick.”