What it will take to solve the US testing problem and safely reopen

• The US must dramatically ramp up testing to give most Americans confidence that can safely return to work during the coronavirus pandemic.
• The White House thinks 200,000 daily tests is plenty, but independent experts and reports call for between 500,000 by mid-May to 30 million tests per day by the fall.
• The Trump administration could help by forcing the production, stockpiling, and distribution of necessary RT-PCR testing supplies by the billions.
• However, without robust incentives for people to get tested, cooperate with contact tracers, and stay in quarantine if they’re sick or exposed, public health says no level of testing will matter.
• Visit Business Insider’s homepage for more stories.

Let’s imagine a world where the United States gets testing where it needs to in order to reopen. And let’s imagine that world through a hypothetical person, James.

Like millions during the coronavirus pandemic, James is restless to leave lockdown and return to the world he knew.

His employer laid him off in early March. Stimulus payments and public support programs have kept his family fed and afloat – barely. They had to exhaust their savings to cover groceries and rent.

But today, James starts a new job on the maintenance staff of a nearby hospital. A wing for elective surgeries is reopening, and his cleaning will be paramount for safety.

James rides the bus to the hospital, where nurses in protective equipment wait outside a check-in tent. One measures his temperature and asks a series of questions about his health. There was that mild cold last week, he says, but feels fine now.

He’s waved over to a seat inside the tent, where he fills a small vial with saliva. A few weeks ago, the nurse would have shoved a swab down his nose to his throat and sent his snot off to a laboratory.

Today, though, a toaster-size machine spits out a result in less than 15 minutes: positive for SARS-CoV-2.

James is debriefed and given a folder. Inside are printed instructions, a two-week voucher for a hotel room, a phone number for a contact-tracing center, and a check for $ 50 – the first of $ 700 he’ll receive over 14 days while in self-quarantine. That’s on top of other paid benefits, enough to convince him not to risk exposing his family. A contact tracer later arranges his family members’ COVID-19 tests and the state provides them with assistance while James is away.

Two weeks later, James returns to the hospital. Two new, palm-size plastic-wafer tests are available. The same nurse asks him to spit into a well on one, then squeezes a few drops of blood from a finger-prick into the well of another. In minutes, the first test suggests he has no current infection. The other indicates he has enough antibodies to protect him against reinfection.

The nurse points him to the hospital’s front doors. James grins: He’s finally back to work.

Testing is the key to safely reopening

Such a hypothetical ideal scenario could be real – if the US can get its act together. But right now, many states are merely pretending it’s safe to reopen during a pandemic.

To be fair, there’s still a lot we don’t know about getting to a place where people can safely return to work en masse. But the stakes are immense: Not doing it right will trigger deadly secondary surges of COVID-19 cases and further lockdown misery.

One thing every public health official agrees on is testing, and a lot more of it. That’s because testing is a kind of superhuman ability that permits officials to see, track, and do something about an invisible killer among a given population; knowing who has the disease and where they’ve been is the first step to combatting the spread of the virus and getting the country back on its feet.

If done well across the US, it’s a critical foundation upon which all other measures to responsibly reopen the country’s economies rest.

To understand how to safely end lockdowns and scale up economic activity via adequate testing, it’s important to know how the US stumbled so hard into the current moment.

Why is US testing still inadequate months after the pandemic started?

Win McNamee / Getty Images

So far during the pandemic, testing in the US has been slow to ramp up and insufficiently administered.

The White House’s dismissive responses, along with caches of official emails and documents, demonstrate that President Donald Trump and his administration did not adequately listen to or act on the urgent calls to action from top experts as the outbreak from China spread across the globe.

Efforts to rapidly scale up testing, contact-tracing, quarantining, and aggressive guidelines were slowed or silenced. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, called the testing situation “a failure” by the government during a March 12 congressional hearing.

The lack of federal leadership during the crisis has left states to figure out testing for themselves with little time, resources, or funding. The lack of coordination has also sparked expensive bidding wars between states and even counties over supplies.

Despite Trump’s insistence that the US has “prevailed” when it comes to testing, it’s clear that more federal action is necessary.

Yet a series of questions remains about how, exactly, the US should ramp up testing and what the future of this critical element of our pandemic fight will look like.

How many tests do we need?

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Several nonprofit organizations with significant brain trusts have published detailed roadmaps to reopening the US economy. Such documents throw out a variety of daily test numbers, but everyone agrees that the 200,000 tests a day the US is currently conducting, and the White House seems to believe is adequate, won’t cut it.

For the imperfect and pandemic-stricken world we now live in, where a safe and effective vaccine is at least year away (if one ever appears) and there is no slam-dunk treatment on the horizon, Dr. Ashish Jha and some colleagues at the Harvard Global Health Institute said last month that 500,000 daily tests by mid-May is a national rock-bottom number to reopen with some confidence and control.

“So there’s the ideal, what we really want to be doing,” Jha, who is the Global Health Institute’s director, told Business Insider in late April. “And then there’s what we have been arguing for, that I’ve been championing, which is not really ideal. It’s not even that great. It’s pretty good, but it’s got a shot of working.”

In a more ideal world where the US can begin to reopen larger parts of the economy, the number of daily tests would be even higher. Estimates of the needed daily testing capacity range from 750,000 – from plans by the American Enterprise Institute and Johns Hopkins University – to 2 million daily tests in June and 100 million tests per day by the fall – a staggering yet logical range laid out in Harvard University’s plan.

Jha said his low number of half a million tests assumes lockdowns will pare back new coronavirus cases to 50,000 total a day – both confirmed and unconfirmed. Right now the US sees about 20,000 to 30,000 confirmed cases per day, per CDC data, but research on asymptomatic carriers suggests the real count may be five to 20 times higher. As states prematurely reopen, expected follow-on surges could easily make 500,000 tests a day inadequate.

So while the exact number of daily tests we need is up for debate, it’s abundantly clear that the US needs a huge leap in the number of tests per day to have the confidence to safely reopen the country.

No one-size-fits-all test exists, though. The type and its deployment matters greatly in monitoring and controlling the coronavirus as state economies open, making it a tricky yet key element of the US testing problem.

What kinds of tests do we need?

Alex Brandon / AP Photo

In order to see COVID-19 where and when it’s spreading, the US is going to need a few different types of tests, each with a part to play and each with some drawbacks.

The first and most important type of test, called RT-PCR – the kind the US will need at least 500,000 of per day to at least monitor the disease – primarily works to detect active infections.

These tests are the type most people are familiar with: a medical practitioner donned in full personal protective equipment shoving a long swab into someone’s nose and waiting a few days on lab results.

For economic reopening to work, this model for COVID-19 detection needs to simultaneously get much bigger and more efficient, with more results returned in hours or minutes instead of days. Thankfully, and despite delays, there is already some momentum in the private industry.

For example, Abbott’s ID NOW COVID-19 test can produces a result within 13 minutes using a tabletop machine. People can be tested on the day they show up to return to work instead of waiting days at home. Spit-based sampling methods, one of which received emergency authorization from the FDA in mid-April, could speed and simplify all aspects of RT-PCR testing.

The second type of tests, which are now becoming available to consumers, looks for immune-system particles called antibodies or immunoglobulins.

The body generates these particles during an active infection but they don’t appear until a few days later. The earliest type of antibody to appear is called immunoglobulin-M, or IgM, which sticks to the surface of a virus to tag it so that immune cells will gobble up infected tissue. Next come later-stage antibodies called IgG and IgA, which help block new infections.

Luna Flores / Europa Press via Getty Images

Labs currently process blood serum to look for such antibodies, which delays results. But handheld tests for meaningful levels of antibodies are starting to appear in the US – plastic-and-paper slabs that are easier to mass-produce and are far less expensive. Instead of requiring a blood draw and shipping service, all that’s needed are a few drops of blood, some liquid reagents, and about 15 minutes.

A catch with any IgM test is that such antibodies typically take a week to appear after infection and tend to fade away. Meanwhile, longer-lasting IgG appears in detectable levels weeks after an infection starts.

Antibody tests also aren’t nearly as sensitive as RT-PCR, which means they can produce false-negatives, or results that suggest a person didn’t have the antibodies when they actually did.

“To identify who’s infected, so we can keep them from people who are not infected, I don’t think antibody testing is going to be the key,” Jha said. “By that time, you’ve had the virus for five, six days that you’ve been able to detect it [with a RT-PCR test]. “

The third type of test that could help greatly is an antigen test. Such a test would ostensibly react to the spike-like proteins that coat the surface of the coronavirus, called antigens, found in a small sample of body fluid.

NEXU Science Communication, via Reuters

Antigen tests could be crude tools of early detection since replicating viruses shed the proteins everywhere in the body. They should also offer simple, near-instant results like antibody tests. And their modest materials should also make them easy to mass-produce and deploy.

But like antibody tests, antigen tests typically have sensitivity issues that can lead to a lot of false-negative results. They’re also difficult to develop, since an intimate biochemical understanding of a virus is required to manufacture them. The FDA is only now beginning to review the first possible tests, such as E25Bio’s. One by Quidel Corp. received emergency approval from the FDA on Saturday.

Since these tests all have issues, it will be necessary to use them together to produce an effective strategy.

With the technology that is widely available, the RT-PCR test is time-intensive and resource-consuming. On-site tests may not scale, and lab machines that can process hundreds of specimens at once can take months to build, qualify, and install, a diagnostics industry executive said. Given that reality, Jha said that RT-PCR testing used early on in reopening will have to change as more people return to work and school.

“The problem is, if we go into the fall with 500,000 [daily tests], we’re going to get crushed, “he said.” And people who are arguing for the tens of millions [of tests per day]? You can’t do it with the PCR technology we’re using. You need a totally different technological approach. “

That’s where the other two tests come in.

Assuming the science bears out, mass-produced antigen tests would become crude detectors of active infections. Using two different inexpensive tests at once may also improve confidence in a result. When there’s a positive or inconclusive hit, a more precise RT-PCR test would follow. People with negative results could return to work.

Mass-produced antibody tests would function similarly, assuming that immunity research demonstrates coronavirus-specific IgG does, in fact, confer lasting protection. Those who test positive for certain levels of the antibody would get an immunity passport allowing them to travel and work until it’s time to retest.

“All that isn’t really real yet. That doesn’t exist. But everyone’s trying to figure this out. … That’s why I’m optimistic about it,” a top healthcare industry consultant told Business Insider in late April.

Who will get tests during reopening? And how will we make enough?

Adam Glanzman / For The Washington Post via Getty Images

Once the US has a targeted level of daily testing and develops the quality of test necessary, the next step is figuring out how to produce and distribute the tests.

The first problem to solve is producing the tests and the materials to administer them. As the reopenings grow in scale, the already incredible demand for swabs, vials, liquid reagents, and other supplies required to run tests will swell.

Jha said the best way to solve the materials issue is for the Trump administration to wield the Defense Production Act more aggressively and force companies to manufacture supplies for the billions of tests we might need.

I emphasized that manufacturing such supplies is almost nothing compared to the trillions of dollars the government may spend in economic stimulus efforts.

“We should not be penny-pinching on swabs and [ingredients] and vials. Even now it’d be fine. Just go make a billion of each of these things. A billion sounds like a lot but it’s not, and at 50 cents a piece in the US, that’s $ 500 million, “Jha said.” If it were $ 1 a piece, it’d be a billion-dollar investment by the federal government. And that’s trivial. “

Jha and other public health experts also emphasized that the government should not be worried about overdoing it.

“In case we’re still relying on PCR, we do not want to be talking about swabs in the fall – so let’s make a billion swabs or two billion swabs and put them in a warehouse. That’s fine. We need it now and we ‘ll use it, “Jha said. “If not, maybe we’ll give them out to people for cleaning their ears later.”

U.S. Air National Guard photo by Airman 1st Class Tra’Vonna Hawkins

Two industry officials whom Business Insider interviewed said most testing supply chain issues should clear in about a month. In a global society that is concurrently emerging from lockdowns and getting back to work – including to the jobs that staff and supply factories themselves – it’s hard to pin down a more precise estimate.

Similarly, reopening the US economy itself is a means to ramp up testing: With people returning to all of the core industries that feed testing supplies, from raw materials and factory production, output and innovation is likely to scale.

Assuming testing supply production continues to ramp up, the next question is: Who gets these tests?

One white paper associated with Harvard’s plan calls for the creation of a national Pandemic Testing Board and the standing up “30 mega-labs across the country” to each tackle about 1 million tests daily. That’d allow the entire US workforce to get tested at least once a week. But federal drive to enact such ideas seem to be essentially non-existent.

For now, it doesn’t make sense to test everyone in the US, at least in the first months of reopening.

Rather, Dr. Joshua Sharfstein, a vice dean at the Johns Hopkins Bloomberg School of Public Health, and others advocate for targeted RT-PCR testing throughout reopenings on high-priority populations. Such sites include hospitals, clinics, jails, homeless shelters, nursing homes, and other places where high-risk people gather, or where conditions don’t support social distancing rules, and “massive outbreaks” can lead to a depressing return to lockdowns.

As more testing capacity comes online, using a combination of RT-PCR, antibody, and antigen tests will allow more industries to defrost and people to return to work.

But even as this testing rolls out, until effective vaccines or frontline treatments bear out – that is, if they bear out – the use of social distancing, face masks or shields, and other precautions would remain in place.

But testing efforts may be for naught if we don’t make quarantine like a paid vacation

Ramzi Boudina / Reuters

The US can manufacture, deploy, and administer all the tests it wants. But without well-constructed public health protocols in place, experts say it’s a lost cause.

“It’s got to be ‘testing-plus’: Testing leads to what actions? Testing alone does not control the virus,” Sharfstein told Business Insider in late April. “Even if you tested everyone 20 times a day, and we literally did nothing else, economically, besides testing in the country, you’re still not doing anything to control the disease. You’re just watching.”

The key moment that has to happen after a positive test for an active infection is contact tracers, or workers who walk a person with the virus through their life of the past two weeks to find any possible exposures to people. Those people who may have been exposed are then contacted and encouraged to get tested.

“If you don’t want to have the whole economy shut down again, then you need a strategy to identify infected people and make them shelter in place so the uninfected people can go about their daily business and live their lives,” Jha said. “That’s the strategy: Keep infected and uninfected people away from each other.”

To effectively implement the sort of tracking needed to open up the economy, at least 100,000 and as many as 180,000 contact tracers could be needed – far beyond the number of people hired to the role so far.

Robert Gauthier / Los Angeles Times via Getty Images

After testing and tracing comes a need for isolation, which – if not incentivized – will discourage people from getting tested at all.

One of the best ways to motivate people to get tested and self-quarantine is to pay them. That’s why Sharfstein and others want people to get paid at least $ 50 per day of isolation.

That may be enough to prevent infected or exposed people (and not just documented citizens) from infecting others, including family members who were depending on the quarantined person.

“You need to be able to support people isolating themselves in quarantine. If they need food, you need to get them food. If they need to move into a hotel, you move them into a hotel,” Sharfstein said.

Jha used a hypothetical example of an Uber driver to illustrate his point.

“If you’re an Uber driver, that’s a real problem. So we need to put you in a hotel, we need to make sure that you get food delivered to you, and we need to give you some income because you’re about to lose two weeks of income, “he said. “If we don’t, you can be very tempted to be like, ‘Screw it. I’m just going to keep working,’ especially if you are asymptomatic.

The importance of such amped-up aid can’t be understated. Even if the perfect tests are developed and those tests become widely available, without this support the US risks a second wave that would cost lives and trillions of dollars.

“It’s going to be super costly over the long run to have to shut down again,” Jha said. “Don’t shut down again. Don’t find yourself in the same place that we found ourselves in a-month-and-a-half ago.”