Put to the test - Dr. Katja Sänger
Infectious Disease
A new frontier for PCR testing

The next batch of blood samples is lined up for processing. Katja Sänger, biochemist and head of the lab, is just about to continue her test series on the hepatitis B virus (HBV) on the NeuMoDx* 288 with the new HBV Quant assay when she feels her phone vibrate inside her coat pocket. The pediatric intensive care unit of a local hospital is calling to have the blood of a premature baby tested for Hepatitis B. The neonatologist on the line needs to know how quickly the result might be obtained. "It will take less than 80 minutes," Sänger replies. 

Dr. Katja Sänger
joined the MVZ Labor Dr. Reising-Ackermann & Kollegen in Leipzig in 2005 with the mission of establishing a new department for PCR investigations – a laboratory she still heads today. Originally, Sänger wanted to become a medical doctor, but as a trainee in the hospital, she felt that her talents lay elsewhere. She started her career in research at the university hospital in her hometown and did her doctorate on target genes in cancer cells in tumor suppression before being recruited by the MVZ.

Sänger heads the Department of Molecular Pathogen Diagnostics at the MVZ Labor Dr. Reising-Ackermann & Kollegen in Leipzig, the largest owner-managed medical laboratory in East Germany. Each day, the laboratory receives approximately thousands of orders from doctors and hospitals for testing, the majority accompanied by several diagnostic requirements. This is a massive workload and the perfect environment for testing the NeuMoDx 288 Molecular System.

Sänger is one of the first scientists in Europe trying out the advanced “Sample to Insight” system. The NeuMoDx 288 is housed in a small side room in the lab, its drawers loaded with consumables and the touch screen ready for the user to enter commands or see results.

“For our molecular biological pathogen diagnostics, we use systems from only two suppliers – those which, in our experience, are reliable, easy to operate, and low maintenance. QIAGEN’s is one of them.”
Dr. Katja Sänger, Head of Molecular Pathogen Diagnostics Lab, MVZ Labor Dr. Reising-Ackermann & Kollegen, Leipzig

The lab already has a QIAsymphony which has been in continuous operation for years, extracting and preparing RNA and DNA from patient samples. "I don't like having lots of different tools that don’t work together,” Sänger says. “For our molecular biological pathogen diagnostics, we use systems from only two suppliers – those which, in our experience, are reliable, easy to operate, and low maintenance. QIAGEN is one of them."

When Sänger started the laboratory nearly 15 years ago, there were practically no ready-to-use assays for use in patient samples, so the lab had to develop their own. "We had to produce most of the reagents ourselves as well,” she says.
MVZ Labor Dr. Reising-Ackermann & Kollegen in Leipzig
was founded in 1990 and currently has more than 1000 doctors in private practice and 40 clinics available to patients 24 hours a day. The laboratory has nearly 300 employees, including 18 doctors and 39 scientists, working across its nine locations in Saxony. This makes the MVZ the largest owner-managed medical laboratory in eastern Germany. The doctors and scientists working at the facility have many years of experience in transfusion medicine, human genetics, hematology, and cytology. MVZ belongs to the "Limbach Group," an entrepreneurial laboratory network with over 30 locations throughout Germany.

After the turn of the millennium, the volume of dangerous pathogens tested steadily increased. For example, practicing doctors now routinely test for Hepatitis B and C, chlamydia and HPV as a precaution. Sänger was hired to rebuild the laboratory to meet this growing demand. “As a young researcher, I was immediately attracted by this challenge,” she says.

Her team analyzes more than 200 samples on an average day, which includes tests for Hepatitis B and C, herpes, HPV, HIV, pertussis, chlamydia, gonorrhea, and influenza. If seasonal waves of influenza roll in, the number of samples analyzed dramatically increases to upwards of 800 a day.

“So far, the NeuMoDx test series has been consistently convincing.”
Dr. Katja Sänger, Head of Molecular Pathogen Diagnostics Lab, MVZ Labor Dr. Reising-Ackermann & Kollegen, Leipzig

Sänger’s expectations were understandably high when QIAGEN offered to install the NeuMoDx 288 Molecular System in her lab. The “288” stands for the number of samples you can load in one go – processing up to 340 tests in an 8 hour shift – completed automatically without any tedious preprocessing work. Sänger says, "This is a whole new approach."

Although the majority of pathogen tests have long been automated in Leipzig, "The fact that this new device is able to prepare individual samples, extract the genetic information, and then analyze it on its own is great,” says Sänger. “There’s nothing else like it available on the market.”

NeuMoDx Molecular Systems
are fully integrated Sample to Insight automation solutions. They carry out all steps of a PCR analysis and diagnostics, from sampling and detection to the results report. The NeuMoDx 288 Molecular System is being tested exclusively in Leipzig. The system boasts throughput times of only 60-80 minutes, compared to more than three hours for other system, and a growing menu of in vitro diagnostic (IVD) tests using dry reagents with a long shelf life.

In the past, Sänger could only test samples for molecular diagnostic assays in batches for single pathogens, using kits in standardized quantities of 24 or 96. "But if I only have a few samples and an urgent request, I had to use the entire kit." The end result would be that the purchased additional controls (several per sample) would end up wasted.

The new NeuMoDx system saves material and decreases waste, says Sänger. But, perhaps most importantly, it dramatically increases sample throughput and accelerates diagnoses, allowing patients to start time-sensitive therapies far more quickly.

Unlike comparable systems, which take five hours to analyze samples, the NeuMoDx 288 can complete a virus load job, from preparation to detection and analysis, in about an hour, says Sänger. She adds, “Since it is able to test individually, I can even reload samples within a certain time window," which, she says, is absolutely unparalleled.

“There are hardly any manual contact points left. And since many reagents are delivered dried and have a long shelf life, our laboratory needs considerably less cold storage space.”
Dr. Katja Sänger, Head of Molecular Pathogen Diagnostics Lab, MVZ Labor Dr. Reising-Ackermann & Kollegen, Leipzig

Over the past year, Sänger and her team have run countless CE-IVD assays such as chlamydia and gonorrhea alongside some laboratory developed tests (LDTs) for flu viruses on the NeuMoDx 288. When the research group tested the safety of the new system, the results were comparable to those which came out of existing laboratory technology. "So far, the NeuMoDx test series has been consistently convincing," says Sänger. In addition, the detection of pathogens can be achieved with less than 10 reproduced copies per extracted DNA, which provides extremely good value.

Because the NeuMoDx 288 is still being tested, it has not yet been linked to the central laboratory information system, which could allow Sänger to forward results to the requesting doctors and hospitals easily. However, once the system completes its review and is linked to the data bank, making that connection will be quite easy. Sänger, like her colleagues, is thrilled that this new system makes handling of pathogens considerably less dangerous for them. "There are hardly any manual contact points left. And since reagents are delivered dried and have a long shelf life, our laboratory needs considerably less cold storage space.”

Once the installation and implementation of the software was completed – everyone in Sänger’s team knew how to operate the system successfully after just a single day of use. "It's practically self-explanatory," says Sänger. Once a German user interface is also an option, "it will be even easier.”

With so many years of experience with more complicated devices, Sänger also appreciates how easy it is to maintain the NeuMoDx 288 Molecular System. "The machine is quickly ready to go and requires little maintenance,” she says. “With our high throughput, having equipment that would require us to start it up and laboriously clean it for an hour in the morning would not be possible.”

Sänger should finish her trial run before the end of the year, after which she will decide whether to make the NeuMoDx 288 a permanent fixture in her laboratory. Though, she is already enraptured enough with the system to say, "It is as if someone has answered all our prayers.”

 

NeuMoDx Molecular Inc. is the legal manufacturer of the NeuMoDx Molecular Systems.

X
Cookies help us improve your website experience.
By using our website, you agree to our use of cookies.
Confirm