In Lake Success, a village on the border of suburban Long Island and the New York City borough of Queens, there is a building that was erected to house defense engineers during World War II. It was designed to withstand enemy bombing, with a pool of water on the roof to help camouflage it in the event of airstrikes.
Today, it is on the front line of a very different war.
The building now serves as the diagnostic testing hub for Northwell Health, a New York health care system with 23 hospitals and 800 outpatient centers. It was one of the first centers to ramp up testing for SARS-CoV-2, the virus that causes Covid-19, and can now run almost 2,000 tests a day. It returns results within a day, sometimes less. Inside, the pace has been furious.
“I don’t think I’ve slept more than four hours in weeks,” said Dwayne Allen Breining, a pathologist and the lab’s executive director. “We’re going at this full speed.”
Across the country, many labs are doing the same. After a month of painful failures by U.S. regulators to expand testing for the coronavirus, the Food and Drug Administration has issued a flood of clearances to manufacturers of testing machines, allowing an estimated 100,000 tests to be run a day. It is a vast improvement of the testing situation just weeks ago.
The question is whether it’s enough.
Whereas a few weeks ago 100,000 tests a day might have helped contain the explosion in new cases — by allowing doctors to tell infected patients to quarantine themselves — it is now hardly enough to keep up with an exponential rise in new infections.
Nationally, the number of Covid-19 cases has passed 160,000, with 66,000 of those cases in New York state and 38,000 in New York City. Clusters are blossoming in cities including Miami, Detroit, and elsewhere, submerging hospitals under a wave of patients who are short of breath from viral infections
Over the next few weeks, the country’s testing capacity is likely to increase further, to perhaps several hundred thousand a day, with some tests able to give results in hours or even minutes. The big question, though, is this: Can diagnostic tests outrace the coronavirus?
By now the U.S. failure to expand testing has been well-documented. Efforts by the wealthiest country in the world paled in comparison with those of other countries. And local and state officials have been furious about it.
When New York Gov. Andrew Cuomo toured Northwell’s testing facility at Lake Success three weeks ago, he lambasted U.S. regulators for not having authorized the lab to conduct coronavirus testing.
Northwell “has automated testing, which expands exponentially the number of tests that can be done,” Cuomo said. “CDC has not authorized the use of this lab, which is just outrageous and ludicrous.” The next day, the lab was cleared by the FDA to start testing patients. Its capacity at the time was 90 tests per day.
That number might not seem like a lot — and it isn’t in the context of nationwide spread. But if the pandemic has taught us anything, it’s that diagnostics are complicated.
The initial test at Northwell was based on the one developed by the Centers for Disease Control and Prevention itself. That test had accuracy problems that had slowed implementation, but even the later version had another problem: It didn’t allow a laboratory to test a lot of cases at once.
At Northwell, it took a lot of effort to test a very small number of patients. “It takes four of my best techs in the lab working on that thing nonstop for a couple shifts to be able to crank out 70 tests a day,” said Breining, the lab director.
Breining’s tried to automate testing with machines from a company called GenMark, a Carlsbad, Calif.-based firm. He might have been able to use that machine, with his existing manpower, to run 600 tests a day. But, as with many other tests, there were limits in how many tests and reagents were available. In mid-March, the system was allowing the lab to test about 120 patients a day.
On March 16, the FDA granted Hologic, a Marlborough, Mass.-based company, an emergency use authorization for a SARS-CoV-2 test that runs on its Panther Fusion system. That system would allow users to run 1,150 tests in a 24-hour period. For Northwell, the machine would become a workhorse.
But for any new test on a new machine, Breining said, there is an “un-compressible” period of two weeks during which the machine must be put through its paces and validated. So even as the FDA approves new testing systems, laboratories have been racing to catch up.
The Hologic machine now accounts for the largest share of the laboratory’s volume, allowing it to keep on top of daily testing for the patients at its hospitals and of its health care workers. A Northwell spokesman said the company now has “sufficient capacity” in terms of hospital beds, but is making preparations to respond to a further surge in infected patients if necessary.
To control the pandemic, Breining said, you’d want to test enough people that the percent of positive tests falls to about 10%. At Northwell, this “positivity rate” can approach 50% on some days.
“That positivity rate tells us we’re only testing a fifth of the patients we’d want to be testing, ideally, if we had unlimited testing available,” Breining said.
Over the past month, the U.S. has taken dramatic steps to be able to test more patients for SARS-CoV-2. In a statement Monday, FDA Commissioner Stephen Hahn said that the agency had worked with 230 test developers since January, and approved 20 tests. The agency also began relaxing regulations so that laboratories like Northwell’s could get up and running more quickly.
An automated test from Roche was approved on March 13, potentially providing 400,000 tests a week. The next day, the FDA approved a test to run on a machine made by Thermo Fisher, which said it would aim to provide 5 million tests by the end of April. The following week, the agency approved a test from LabCorp and the Hologic test. At the time, Hologic said it would be able to provide about 600,000 tests a month.
Even as capacity expanded, doctors and patients have reported long wait times for results. LabCorp and Quest initially had official turnaround times of several days; some patients still report waiting as much as a week for a result.
The FDA has given emergency clearance for a test from Danaher that takes just 45 minutes and is targeted at emergency rooms. Abbott Laboratories received emergency approval for a test that runs on a small desktop machine and can return results in five minutes. Abbott said it can manufacture 50,000 of the tests a day.
But all that capacity, even if it can deliver results fast, won’t quite make up for lost time. Consider the case of the Stanford Clinical Virology Laboratory, which began working not with the CDC’s test, but with the alternative one that had been developed by German researchers and used by the World Health Organization. By the time the FDA eased regulations, Stanford launched testing in a matter of days, and was soon testing 1,000 patients a day. It hurts to imagine what would have happened had more labs been as prescient.
What will it take to get to a situation that doesn’t require the entire population to be huddled at home, trying to slow the spread of the coronavirus so that the volume of infected people does not overwhelm our hospital system? Experts say that to some extent, the answer is that it’s a waiting game. Spread of the virus must slow enough so that testing can catch up.
It won’t just be a matter of having enough diagnostic tests, but also having public health workers locate people who might be infected to test them as well as being able to return results to patients quickly. These are probably the big bottlenecks, now. A recent report from the American Enterprise Institute co-authored by former FDA Commissioner Scott Gottlieb puts the number of tests needed at 750,000 tests per week. There will also need to be a different kind of test, to detect antibodies against the virus to identify people who have already been infected and may have immunity.
The story of U.S. diagnostic testing in this case hasn’t been a failure of innovation alone, but also of logistics. After the first tests reached the market, there were shortages of other chemicals, including kits for extracting the virus before a test could be run. Then, hospitals started running out nasal swabs.
To make use of the surging test capacity, the U.S. is going to have to do better. And as fast as diagnostic companies have moved, it may not be fast enough.
A virus is a terrible thing to race.
Testing must be stepped up – for health care workers AND many people with symptoms that are now told they’re not sick enough for a test. The sooner there are enough tests, the sooner this disease can be tackled, and the sooner people can get their lives back. I fully agree and 100% comply with the shelter-in-place / isolation regime, but I fear that at some point people’s patience will run out. That could have horrific results (curfews, military, jail, looting, vandalism, and then all those guns that Americans are buying …..)
Dwayne Breining of Northwell says he hasn’t slept more than 4 hours in a week. Such “heroic” efforts put everyone at risk. First, with that amount of sleep, he’s going to be making mistakes. Secondly, there are so many people being laid off – let’s employ people in the medical tech industries. Even if they need training on new technology, the demand for their services isn’t going away any time soon.
Exact Sciences in Madison, WI is reportedly making 4-5K tests daily. This significantly exceeds the capacities you’ve quoted in your article. However all of WI has tested about 3k ppl in the past couple of weeks. I’m curious where/how the tests are being used? (assuming these are diagnostic of active infection).
Is anybody looking into comparing the number of deaths per week or month now compared to maybe last year at this time? It would put things in perspective as to how many more may be dying because of the COVID 19 virus or not.
That’s a great idea! We can’t trust the federal government to report deaths from Covid19, even if they wanted to. Seems like comparing deaths in general might circumvent that, and perhaps some conclusions can be drawn from that data. Way to go you (and your brain)!
Last year at this time, we didn’t know coronavirus existed. We cannot compare to deaths from any cause. Although the data are collected for deaths for any cause–separate from coronavirus, we don’t have any data for coronavirus deaths a year ago.
We know how many deaths are attributable to Covid-19 on a daily basis in the U.S. The U.S. counts are accurate and reported daily – available for all of us, this provides all of us a very clear measure of the impact Covid is having. This data is available on nonrefundable sites, including John’s Hopkins, Stanford, the CDC and many more. Look at those sites for accurate info. This is a novel virus- no known U.S. deaths were due to it last year.
Testing is not happening. I (after being under the CA stay-at-home order for nearly two weeks with limited moving around since the first week of March) have had a very sore throat and hacking cough for 3 days (but no fever). The CDC says I should talk to my doctor about being tested. After trying to get in touch with my doctor, I was emailed a generic response that they are not testing anyone with mild symptoms because they want to keep people with mild symptoms out of their offices. This is a major heathcare system provider. I do understand the overriding interest in keeping our healthcare providers healthy, but how are we supposed to know who has the virus and who does not – and how much it is spreading – if they won’t test?
If you haven’t been in public for three to four weeks, seems highly unlikely you’ve got Covid, unless someone in your household has been out and about.
I don’t understand how testing us the answer to containing the virus. If we achieve what Dr. Gottlieb, says we need to, 750,000 a week, which may not even be possible, that means in 3 months we’ll only have tested 9 million people. That leaves 325 million people out there untested. Also, we aren’t testing people without symptoms, but it’s my understanding that half or more people with the virus are asymptomatic, but contagious. I can’t really understand how testing will do very much good except for testing the healthcare providers to make sure they aren’t passing it along.
Please explain what Im missing.
One of the major problems at this point is preventing new infections from traveling to “clean” areas. Northern Nevada has been at home for more than 2 weeks, at great cost. There aren’t many new cases in the hospitals. Yet, the planes continue to fly. The first death was a man who traveled from NYC to Reno on March 23. Had he not become critically ill, he may very well have started a new chain, thus undermining all the sacrifice made to date.
The Governor of New York threatened to sue a small state, Rhode Island, when they announced a self-quarrantine order for New Yorkers. RI rescinded the order.
”MARCH 31, 2020 AT 1:13 PM
The Governor of New York threatened to sue a small state, Rhode Island, when they announced a self-quarrantine order for New Yorkers. RI rescinded the order.“
That’s not what happened, RI was targeting and pulling over cars with NY license plates and messing with them, that’s what the threatened lawsuit was about. It wasn’t about having NY residents self-quarantine. Get you facts straight before you start spreading Facebook misinformation.
Testing less relevant at this point. After a couple of weeks of even loose “ lockdown” infections are declining rapidly. The crisis is effectively over in some parts already, such as Washington and Northern California.
This is a very uniformed viewpoint and I suggest you look at CDC infection data and testing numbers again before coming to that conclusion. In both of those areas the numbers of cases are still most likely rising but testing does not have the capacity yet to treat enough people. While the rate of the spread has hopefully decreased with social distancing the opportunity for underdiagnosis or reintroduction is very likely.
What the hell are you taking about? Cases and deaths in Northern California are still steadily rising, and will most likely continue to do so for a while yet.
Testing is absolutely necessary and more relevant now than ever. We haven’t yet reached the pinnacle of the curve. Did you honestly not know that or do you have an agenda?
Please go back to work, President Trump.
What about assay QA? Accuracy matters.
Comments are closed.