Tracking infections and securing supply chains: The race against a virus

Identifying chains of infection to limit uncontrolled outbreaks became the number-one priority in pandemic management in the spring of 2020. The polymerase chain reaction (PCR) test used for this is a standard procedure in viral diagnostics that can show whether SARS-CoV-2 genes are present in a sample.

Subsequent contact tracing then aims to make the chain of infection visible and stop the virus from spreading further. Yet, how was it possible to adapt existing tests to the SARS-CoV-2 virus and distribute them so widely in such a short space of time?

Dividing the work between Luxembourg and Marburg made it possible to start producing the tests on a mass scale. Coordination was crucial: From the delivery of the individual components to sending the finished tests to the distribution centers in Europe and the USA, every step had to be precisely planned. Mathias Ganzmann was responsible for the supply chain management at the Marburg site. He can clearly recall the complex workflows: “At first we were just involved in packaging and distributing the tests to Europe and America. Luxembourg was still doing the filling, but once we had more capacity, we started doing that, too. Obviously, we were all under huge time pressure and had to complete multiple steps in the shortest possible time.”

One of the main challenges when producing PCR tests is maintaining the cold chain, as the tests must always be handled and stored long-term according to their specific labeled conditions, including during shipment. Luckily, usable infrastructure already existed between Siemens Healthineers and the distribution centers.

“As well as sorting out all the formalities, we obviously also had to win our employees’ trust for the new working situation because we haven't historically produced molecular diagnostic test kits. It was all very new. So it was really helpful that Luxembourg and Marburg pulled together,” says Ganzmann.

In addition to winning the trust of employees, providing reliability for customers was also very important in such an unusual situation. Stable supply chains and a well-connected infrastructure were essential for achieving this – as was close collaboration with the approximately 50 companies that supplied the sites in Luxembourg and Marburg with the various components for the tests. Usually, demand for the individual components is very constant, but it can quickly multiply if production increases – as was the case in spring 2020, when a huge number of companies began producing very high volumes of PCR tests to detect the novel virus. This can cause supply shortages that, in the worst case, will force production to stop.

Manufacturing at a mass scale usually involves long planning phases, but these just weren’t possible in spring 2020. “It normally takes six to seven months to get that kind of thing up and running. We had to do it in a few weeks,” says Mirza Kokic, head of quality management and regulatory affairs at Fast Track Diagnostics. In May 2020, as the pandemic raged around the world, Marburg began producing even more PCR tests.

What’s more, they did it in record time: In just three months, the test was available globally and the demand kept increasing.

Kokic recalls the challenges of the first few months: “When the pandemic broke out, we were working according to priorities that were based on goals set before the virus arrived. So of course we had to change them all. But we realized that we were in the unique position of being able to make a difference by actively tackling the pandemic. So that’s what we did.”

Despite their best efforts, it wasn’t long before the first obstacles appeared: The Luxembourg site doesn’t just employ Luxembourgers – its workforce also includes many Germans and Belgians. Kokic himself lives in Germany and had to cross the border every day. “Normally there isn’t a controlled border, but then the authorities set up a checkpoint. It was a bit like in a war zone. The police were patrolling with these big guns and I really wondered how we would manage. How were we going to achieve our goal if we couldn’t even leave our homes?”

The international restrictions were not the only things making the situation harder; the lack of certainty and the new hygiene and social distancing rules also significantly complicated everyday working.

Nevertheless, the team led by Michael Schleichert, managing director and head of R&D at Fast Track Diagnostics, concentrated on creating focused yet flexible processes that would help ease the personal situation for the staff. “We obviously had the same problems as employees everywhere – no childcare, closed borders, people were worried. But we knew that we were doing something important, and that kept us going,” says Schleichert.

Before a SARS-CoV-2 PCR test can be approved for clinical use, it requires various types of certification depending on the particular country. In European countries, the tests must have CE marking, in the United States the FDA is responsible for approving medical devices, and in Asia the rules are different again.

“As you can imagine, the market in 2020 was flooded with tests that too often didn't perform very well. We wanted to make really sure that our test was reliable,” says Kokic.

With PCR tests, reliability depends on two things: sensitivity and specificity. Sensitivity indicates the percentage of infected people that the test correctly identifies as infected. Specificity shows what percentage of healthy people the test recognizes as being healthy. Under laboratory conditions, these percentages are often very high. In practice, however, many errors can occur – such as the tests being handled incorrectly or a sample not being taken properly. Testing for one or several virus genes can also affect the results.

Making a highly reliable test requires enormous amounts of data. “We didn’t want to seek regulatory approvals for our test kit before we had a high-performing test and robust supporting clinical data,” says Kokic. “Fortunately, we had a partnership with a local laboratory in Luxembourg and we could use their samples to validate our tests. This allowed us to gather the clinical and analytical data quickly and safely, and apply for the required authorizations.”

This precision paid off: In May 2020, the test secured the required authorizations for both the European and American markets. Kokic is proud of this: