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Corona Challenge Germany Reaching the Upper Limit of Testing Capacity

Every day, tens of thousands people in Germany seek to get tested for the novel coronavirus. Often, though, they run up against a lack of testing capacity. And it is likely to only get worse. By DER SPIEGEL Staff
Mobile testing site in Berlin: At some point, Germany will no longer be able to increase testing capacity.

Mobile testing site in Berlin: At some point, Germany will no longer be able to increase testing capacity.

Foto:

FABRIZIO BENSCH / REUTERS

By Matthias Bartsch, Jan Friedmann, Matthias Gebauer, Annette Großbongardt, Hubert Gude, Julia Jüttner and Miriam Olbrisch

When Sascha Stoltenow held a training course back in March, the new coronavirus, SARS-CoV-2, had already made an appearance in his life. The only problem was that Stoltenow didn't know it yet.

Four days later, back in his hometown of Wiesbaden, the communications consultant learned that the Hamburg Academy had to be closed temporarily because someone there had tested positive for the virus. One phone call later, Stoltenow realized: "I had direct contact with the infected person."

The next day, the 50-year-old Stoltenow felt a "slight scratching" on his tongue and the roof of his mouth. He called the medical hotline 116 117 and was told go to Frankfurt to undergo a virus test. At first, the doctor there didn't want to test him, Stoltenow recalls. "She thought the symptoms were too mild."

But he was able to convince the doctor to perform the test anyway. "Luckily," he says. The result was supposed to be available the next day, but Stoltenow didn't hear back. Another day went by and he eventually called the local health department. "I was told they didn't have a file on me." Stoltenow suspected the test hadn't been processed and stayed home, just in case. Then he heard about two other people who had attended the conference in Hamburg whose tests had come back negative. "That's when I stopped quarantining."

It wasn't until eight days after being tested that Stoltenow received the news: His results were positive. The health department had apparently misfiled his results. The 50-year-old immediately went into quarantine with his entire family. But there was a problem: Before he discovered he was positive, he had attended a university event and had been in contact with around 150 people, all of whom could theoretically have been infected by him.

There are countless reports like this one. They involve constantly busy telephone hotlines, testing being either refused or postponed and people waiting days for their test results -- if they hear back at all.

Incessant Pestering

One family from Munich relates how they were ignored by the authorities after telling them that they had returned from a ski holiday in South Tyrol and their children, 4 and 7, had developed symptoms. "The hotline 116 117 didn't work at all. The health department took down our information but never got back to us," says the 39-year-old father.

In the end, by virtue of sheer incessant pestering at a testing facility, the family managed to obtain a test for their daughter. Fortunately, it came back negative.

DER SPIEGEL 14/2020
Foto:

cgs

The article you are reading originally appeared in German in issue 14/2020 (March 28, 2020) of DER SPIEGEL.

In Hamburg, kindergarten teachers report trying in vain to get coronavirus tests from their doctor after one of the children in their emergency daycare center tested positive. In the southwestern state of Saarland, the interior minister called in the army to help after lines a hundred meters long formed in front of one of the test centers. Some of the people who had been waiting for hours outside were sent home empty-handed. The facility couldn't handle any more people.

In the region of Upper Swabia, as many as 2,000 samples that had been submitted to a lab expired because important ingredients for the test procedure were missing. The state health ministry called the people back to be retested, but only those who "now have flu-like symptoms and a fever of at least 38 degrees."

Those who try in vain to get tested for the coronavirus these days can count on little more than the sympathy of German Health Minister Jens Spahn. It's a "deeply relatable feeling" that people want to know whether they're infected. However, in view of the "limited capacities," public health officials must decide "together" who gets to be tested and who doesn't.

Not even Spahn knows just how big Germany's testing capacity is. There are hundreds of private laboratories distributed throughout the country, and that's in addition to university clinics and hospitals overseen by state governments.

Well Equipped Yet Far From Sufficient

Last Monday, Spahn provided the figure of 200,000 tests per week. Statistics from his ministry put the number at 300,000. The virologist and government advisor Christian Drosten, from Berlin's Charité hospital, spoke last Thursday of estimates in the "range of half a million." But even at that rate, it would take around three years to test the entire German population.

Compared to other countries around the world, Germany is well equipped with its current laboratory infrastructure, experts say. Nevertheless, the laboratory operators' association ALM admits the country's testing capacity is far from sufficient to meet the high demand.

"Ideally we would be testing aggressively throughout Germany," says Hendrik Streeck, director of virology at the University of Bonn. "We see in South Korea that this is the best strategy." There, comprehensive testing has made it possible to find virtually every infected person and separate them from healthy ones. "This enabled them to minimize the chains of infection very quickly," says Streeck. "The epidemic was contained there before it broke out."

Such a strategy, though, would run into technical and organizational limits in Germany. Many labs have automated, high-performance instruments capable of evaluating more than 1,400 -- sometimes even more than 4,000 samples -- in 24 hours. But analysis is a multi-stage process that requires special substances, chemicals and other resources.

Sascha Stoltenow: "That's when I stopped quarantining."

Sascha Stoltenow: "That's when I stopped quarantining."

Foto: BERT BOSTELMANN / BILDFOLIO / DER SPIEGEL

"These aren't just any random chemicals that can be mixed together," Streeck says. "We need enzymes that are produced through biological processes by cells or yeasts. Such complex processes "can't be ramped up at will on short notice." Manufacturers, some of which are based in the U.S., are currently receiving inquiries from all over the world.

But the biggest bottleneck at the moment isn't even due to the lack of reagents, with which the genetic material of the coronavirus can be specifically detected, says Hendrick Borucki from the Bioscientia laboratory network. There's also a shortage of the substances that can be used to break open the virus envelope and isolate the genetic material for the actual test. Other laboratories complain that even plastic pipettes or carrier plates that are calibrated for the analytical instruments are becoming increasingly difficult to obtain.

"Wasting Valuable Reagents"

There is a danger that the lack of reagents could soon mean that fewer tests will be available than there are today. Meanwhile, the number of infections is expected to continue increasing.

To manage the looming shortage, lab operators have called for an even stricter decision-making process for who gets tested and who doesn't. Only people who are at risk or showing symptoms should be tested, they argue. "At the moment, we're still testing way too many healthy people," says Borucki. Well over 90 percent of the tests evaluated by Bioscientia come back negative. "We're wasting valuable reagents."

The Robert Koch Institute now feels the same way. "We don't have enough tests to be able to use them senselessly," the institute's director, Lothar Wieler, warned last week. At the same time, though, the institute has loosened the recommendation that has thus far been in place - namely that patients with symptoms should only be tested if they had contact with an infected person or had been in a region with a high number of confirmed cases. Given that the pathogen is now essentially everywhere, the focus on at-risk regions no longer makes sense, an institute spokeswoman said.

Limiting tests to people showing symptoms is a matter of some disagreement among experts. "We know of cases where the test returned a positive result even though the test subject was showing no symptoms at all," says Streeck, the virologist. A study from Hong Kong found that as many as 40 percent of the infections took place in the phase before symptoms developed, Streeck says. These virus carriers who have no symptoms can spread the pathogen and unwittingly endanger others, he adds.

The rule is also inscrutable for many of those affected. "We didn't have any symptoms, but we were concerned," says a 45-year-old mother from Hesse. The father of her two sons had been in the Austrian ski resort of Ischgl  with friends, and after he returned home, the boys spent a weekend with him. Soon thereafter, Ischgl was declared a high-risk area for the virus and the father and five of his friends all tested positive for the virus. The mother contacted their family doctor, who referred them to the health authorities. There, she was told that tests would only be performed if she or the children developed symptoms. "We wanted peace of mind, so we fibbed," the woman admits. Together with her children, she drove to a test center set up in front of a hospital in Worms and said she had a slight fever.

Some of those who cannot get tested through the public health-care system turn to the free market to get what they want. In parts of the industry, says a leading lab doctor in Baden-Württemberg, there is "gold fever."

A lab in Hamburg, for example, is offering a coronavirus test that patients can perform at home. The process for taking the swab is explained on the company's website with the help of diagrams. Users insert the swab into their mouths until it extends behind the uvula. It is then placed in a test tube and sent to the laboratory or placed directly in their mailbox.

Out of Pocket

Some 300 such tests are submitted each day, says laboratory director Jens Heidrich, and the results are generally available just 24 hours later. "Getting rapid clarity is an enormous relief for people," he says. But the test costs 150 euros and has to be paid out of pocket.

Heidrich insists that the tests adhere to WHO standards and are reliable and adds that he ends up with more positive results from those who send in samples privately than tests performed by doctors on patients. A Hamburg association of doctors in the public health insurance system, however, warns against using the tests "because it is extremely likely that the samples from patients are not being obtained properly."

The samples have to be taken so far back in the throat that it generates severe gagging in most patients, say experts. That leads to many self-performed tests not being done correctly, and even some family doctors do it incorrectly as well: "They just swipe around a bit," says the lab doctor from Baden-Württemberg. The result, he says, is likely many incorrect negative results.

The fact that a significant amount of time can pass between when the swab is taken and when it ends up in the lab is also a problem. Lab doctors say the tests are most reliable when the samples are constantly kept cool as they are transported. Test producer Roche, which supplies many German labs, says that samples only remain viable for a maximum of 48 hours, assuming they are kept at temperatures between 2 degrees and 25 degrees Celsius (35.6 and 77 degrees Fahrenheit).

Even lab operators that do not normally analyze human samples are entering the market. The veterinarian Klaus-Peter Behr, 60, has a bucolic view of farmland and a nursery garden from his office in the village of Emstek, located not far from Bremen. Behr's lab employs 180 people. "Without adding any capacity, we can analyze up to 1,000 tests per day for the novel coronavirus," Behr says, "seven days a week." Behr has said the same thing to public health officials, adding that he can deliver results within three to four hours.

But health officials in his state of Lower Saxony declined the offer, writing: "Cooperation requires approval and the involvement of a specialist in laboratory medicine (human medicine)." Behr is now offering the tests to private customers and pharmacies. He is also producing test kits for other laboratories.

The fundamental challenge, though - namely the exploding global demand for the reagents used in the test – cannot be solved by the veterinary laboratories either. And neither can the mini test devices that are currently being touted for their alleged speed improvements relative to those devices that have thus far been used.

"Intelligent Testing"

Streeck believes that "creative solutions" are necessary. Instead of individually testing 10 people with limited risk of having contracted the coronavirus, their samples could be "pooled" and analyzed together. When the result is negative, then nine tests have been saved. If the result is positive, individual tests can still be performed.

Such an approach, Streeck says, has proven itself in testing donated blood for HIV or hepatitis. If it is done correctly, the number of people tested using the same amount of material can be significantly increased.

Other experts recommend using the tests available for important occupational groups. "In the long term, we cannot regularly test the entire population of Germany," says Michael Hoelscher, director of the Division for Infectious Diseases and Tropical Medicine at the University Clinic in Munich.

Because testing capacity is now reaching its limits, "intelligent testing" is necessary, says Hoelscher. "Police officers, fire fighters and especially people in the health-care industry are regularly in contact with at-risk patients. There we have to be as sure as we can that these people are not infected."

The rest of the population should only be tested when they exhibit strong symptoms that require hospital care, Hoelscher says. "Those that only have mild symptoms should please stay home and not demand a test."

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