Infectious Diseases
Is it Influenza – or something else?

Beep – beep – beep. An elderly patient with a glucose drip inserted into his arm lies on a bed inside a shock room, an area managed by both the hospital’s emergency and ICU staff to stabilize all acutely ill patients. He is being tested for respiratory pathogens, everything from adenovirus to multiple subtypes of parainfluenza. After a nasopharyngeal swab test is taken from the patient, a technician places it into a QIAstat-Dx cartridge. Once the barcode on it is scanned, he carefully loads it into a sleek box the size of a small printer – The QIAstat-Dx.

This small, unassuming machine represents the next generation in multiplex molecular diagnostic systems and can identify over 20 viruses and bacteria in its respiratory panel. Another panel also tests for gastrointestinal pathogens and parasites. Perhaps the most beneficial achievement of this system is that it can determine co-infections and provides results in under an hour.

Dr. Benoît Visseaux and Dr. Celestin Alexis Agbessi discuss their experiences with syndromic multiplex diagnostics at Bichat-Claude Bernard hospital in Paris – is one of the first users of QIAstat-Dx in Europe.

Dr. Benoît Visseaux, virololgist at Bichat hospital and a self-proclaimed “lab guy”, is a thin man with a stubbly beard, typically dressed in a white lab coat with a multitude of pens peeking out of his the breast pocket. Each flu season, Visseaux and his team run between 800 and 1000 respiratory tests for the emergency department. Visseaux notes that in the past, doctors never had complete information when starting treatments. “Patients often enter the emergency room with a number of symptoms that don’t allow for a clear diagnosis,” he points out. “A patient might have the flu and be treated unnecessarily for something else, which is costly for the hospital and could result in side effects in the patients.”

"Patients often enter the emergency room with a number of symptoms that don’t allow for a clear diagnosis."
Dr. Benoît Visseaux, Bichat-Claude Bernard Hospital, Paris

Benoît Visseaux
is an associate professor at the laboratory of virology. He has a PhD in Virology and a Master in microbial ecology, physiopathology and treatment. His fields of interest are HIV physiopathology, resistance and diversity. He also works on the respiratory viruses' epidemiology and clinical impact.

Dr. Visseaux calls syndromic multiplex diagnostics like QIAstat-Dx “nothing less than a small revolution.” It merges two key trends in global healthcare: Point of Care testing and Molecular Diagnostics. Experts estimate that it could soon replace frontline test protocols with the reduction of costs and improvement in outcome.

The Bichat-Claude Bernard Hospital
is a marriage of a squat, red and yellow stone building to an imposing 1970’s high-rise of sleek steel and windows. It sits just inside the beltway that separates Paris from its suburbs, and is one of the most important emergency hospitals in the entire city. More than 90,000 urgent-care patients are treated here per year, and the hospital offers further specializations in different medical and surgical disciplines.

Bringing the lab to the emergency room

Before QIAstat-Dx, when urgent questions arise in the emergency room, the answers were sought elsewhere: In the lab. Visseaux would dispense a sample to the lab via a pneumatic tube system, where results often took hours, sometimes even days, during weekends or holidays, when the lab wasn’t staffed.

As a result of this delay, patients with suspected influenza are often isolated, strictly as a precaution to avoid exposing other patients. For the hospital, this means that beds and rooms are often unnecessarily blocked, or that physicians feel compelled to prescribe antibiotics before any infection is confirmed, which, if unwarranted, can contribute to the rise of antibiotic-resistant bacteria.

With QIAstat-Dx, the lab resides in the emergency room. The machine is small enough to place without getting in the way of hospital staff who need quick access to patients, and is easy for nurses and technicians to use, even with complex, cutting-edge testing taking place within the machine itself. A user needs less than one minute of hands-on time to prepare a sample for this system, which surveys a large number of pathogens, and produces answers fast and onsite, right where they’re needed.

Unexpected Insights

“With QIAstat-Dx we get the results virtually upon the patient’s arrival at the hospital,” says Visseaux. Moreover, “it has also led to some unexpected insights. It used to be, for instance, that the respiratory syncytial virus was thought to be the cause of severe respiratory illness only in children. Such on-the-spot testing has now shown that it lies at the root of many severe infections in adults as well.”

“It changed our perception, our prescription habits, and it will change the way we work in the future.”
Dr. Celestin Alexis Agbessi, Bichat-Claude Bernard Hospital, Paris

The impressive little system also reduces the quantity of medications prescribed. “It changed our perception, our prescription habits, and it will change the way we work in the future,” says Dr. Celestin Alexis Agbessi, Visseaux’s colleague, while cleaning his classes. Agbessi is convinced that if you change prescription habits and how you think about the patient, you save money, see fewer side effects, use less antibiotics and save time. “In the end,” says Agbessi, “we gain money for both the community and the patients. That is really a big step forward.”

Célestin Alexis Agbessi
is an emergency physician at Bichat-Claude Bernard hospital and reviewer for the World Health Organization. He speaks five languages, has experience with politics and public health, and is passionate in finding improvements in the medical treatment of patients.

A class of its own:

The QIAstat-Dx is the only multiplex syndromic testing system based on real-time PCR (polymerase chain reaction) designed with the additional capability of processing immuno-assays. RNA molecules are amplified 40 times simultaneously in a reaction vessel with an internal control in a single step. It is a significant improvement over currently available systems that offer rigid panel designs, and therefore require co-processing of molecular targets found to be irrelevant in the patient sample, which may complicate reimbursement.

With novel Sample to Insight solutions powered by QIAGEN chemistries, the QIAstat-Dx enables fast, cost-effective and flexible syndromic testing.


– Results in about one hour
– One-step diagnostics by an all-in-one mini-lab
– Contains wet and dry reagents
– Comprehensive controls from start to finish
– Room temperature storage
– Exclusive dry swap protocol

The broader pipeline of assays and applications for QIAstat-Dx spans infectious diseases, oncology and companion diagnostics, transplantation patients, quantitative analysis, and immunoassay testing. The additional capability to process immunoassays creates unmatched target and application versatility, as well as disease management options.

 

Market outlook

The QIAstat-Dx assay cartridges have significantly lower manufacturing costs compared to other systems and offer seamless bi-directional integration into laboratory information systems (LIS), adding further efficiencies and reducing system management costs.

QIAstat-Dx launched in Europe in April 2018 and, in May 2019, following US Food and Drug Administration (FDA) approval, will launch in the U.S. The American Society for Microbiology predicts that syndromic testing will become increasingly common and performed outside clinical microbiology laboratories. The use of these assays in point-of-care settings demands thoughtful implementation strategies, with guidance from both clinical and laboratory professionals. QIAGEN estimates around 1.1 million tests per year in Europe and 1.5 million in the United States for its respiratory panel.

 

QIAstat-Dx (formerly DiagCORE) is for in vitro diagnostic use. QIAstat-Dx is not available in all countries.

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