QIAstat
Infectious Disease | QIAstat-Dx
Revolutionizing Diagnostics

A quiet revolution is transforming the way hospital patients are diagnosed with potentially serious infections. This major shift is moving sample testing out of the lab and much closer to the patient, where it can detect the pathogens behind a whole host of common syndromes.

It is made possible by a compact, sleek looking device, the QIAstat-Dx, which is at the forefront of the growing diagnosis technique known as syndromic testing. The impact on patient care is profound. The QIAstat-Dx gives accurate diagnostic results in around one hour, in multiple healthcare settings, which facilitates fast, effective treatment.

Annual flu epidemics

cause up to five million cases of severe illness, and up to 650,000 respiratory deaths per year, the World Health Organization estimates. There are four types of seasonal influenza virus, two of which cause seasonal epidemics. Most patients do recover from their symptoms within a week without medical treatment.

Two testing panels are currently available for the QIAstat-Dx. Together, they can detect more than 40 targets that cause a slew of respiratory and gastrointestinal infections. Dr. Glen Hansen, Medical Director Microbiology & Molecular Diagnostics, Hennepin County Medical Center, Minnesota, explained: “Screening for respiratory viruses, particularly among hospitalized patients, is now a contemporary diagnostic standard. The QIAstat-Dx is easy to use and offers labs and patients a fast and sensitive option for sample to result testing of multiple different targets in roughly one hour.”

“Multiplexing for syndromic testing is really on the horizon for many, many laboratories at the moment. Particularly because the users, the clinicians, can see this as something that speeds up the patient experience in hospital and reduces in-patient costs significantly because of the speed of the return of the results.”
Dr. Mairiead MacLennan, Professional Manager of the Department of Medical Microbiology & Infection Control at North Laboratory Victoria Hospital, NHS Fife, Scotland

Patient samples have always been sent for individual lab tests based on the doctor’s best estimate of the likely pathogen causing the illness. Negative results often led to delays in treatment and risked further contagion. The QIAstat-Dx solves that problem by simultaneously testing for multiple pathogens. What’s more, the device’s tests do not need to be carried out in a laboratory environment. Instead, they provide fast, accurate results much closer to the patient.

Real-time PCR

is a key technology for monitoring a defined segment of DNA, as the reaction happens. It is a key technology in molecular biology that has many applications, including in hereditary disease research and cancer diagnosis. Now, syndromic testing is also included.

A real-life scenario would involve doctors assessing a patient showing common yet non-specific symptoms such as fever, aching limbs, tiredness, coughing, or a headache. Instead of sending samples for laboratory testing, the QIAstat-Dx’s respiratory testing panel can screen the sample for common viral and bacterial pathogens that cause acute respiratory tract infections. These include various strains of influenza, which can be fatal for vulnerable patients.

Point-of-care testing

has the potential to move test-sample diagnosis out of the laboratories and into the physician’s offices, hospital wards, and even ambulances. Moving diagnostics closer to the patient can facilitate a faster and more patient-centered approach to healthcare delivery.

Meanwhile, the gastrointestinal panel runs tests for more than 20 of the most common viral, bacterial, and parasitic pathogens that cause near-identical patient symptoms, such as vomiting and diarrhea. These pathogens include different strains of the norovirus, pathogenic campylobacter, and salmonella.

“Ease of use was very important because you can be trained in two hours. Basically it is very, very easy to use.”
Prof. Vincent Thibault, head of the virology laboratory at University Hospital of Rennes

Prof. Vincent Thibault, head of the virology laboratory at University Hospital of Rennes, France, has tested the QIAstat-Dx for himself. He described the speed and accuracy of its results as “striking,” and praised the device itself as being straightforward to operate. “Ease of use was very important because you can be trained in two hours. Basically it is very, very easy to use,” Prof. Thibault said.

It takes around one minute to place an appropriate patient swab inside a plastic cartridge containing reagents and buffers. That cartridge then slots into the QIAstat-Dx, which provides test results in little more than an hour. The device’s testing technique draws on a process called real-time PCR.

Salmonella bacteria

are a major cause of foodborne illnesses around the globe, according to the World Health Organization. Eating contaminated meat, poultry, eggs, and milk are the most common ways of contracting the bacteria. Infection symptoms include fever, abdominal pain, nausea, and diarrhea.

The QIAstat-Dx’s results help physicians to decide whether a patient should be quarantined, what treatment to administer, and for how long.

Even negative test results are extremely helpful because they rule out a high number of possible pathogens, indicating that the cause lies elsewhere. Further, the QIAstat-Dx is extremely safe for healthcare professionals to use because they do not need to manipulate patient samples. The device provides benefits for the patients, the healthcare provider, and the system overall.

“The QIAstat-Dx is easy to use and offers labs and patients a fast and sensitive option for sample to result testing of 20 different targets in roughly one hour.”
Dr. Glen Hansen, Hennepin County Medical Center

The analyzer’s sleek user-friendly design even won it the prestigious UX Design Award 2018 and judges praised the QIAstat-Dx for providing excellent user experience. The multiplex system has already launched in Europe, the USA, and the Asia Pacific region, earning positive feedback at its official European debut in April 2018 at the European Congress of Clinical, Microbiology & Infectious Diseases, held in Madrid, Spain. Speaking at the event, Dr. Glen Hansen said: “The field of clinical microbiology is incredibly excited about the launch of the QIAstat-Dx in Europe. It provides laboratories with a robust, rapid response with a full menu of syndromic-based testing that we look for in the clinical lab space.”

Noroviruses

are the number one global cause of acute gastroenteritis. There are currently no vaccines to combat infection. People living in the USA develop a norovirus infection on average five times during their lifetime.

The device’s versatility, speed, and ease of use all impressed prospective users and buyers. Dr. Mairiead MacLennan, Professional Manager (Quality & Training) of the Department of Medical Microbiology & Infection Control at North Laboratory Victoria Hospital, NHS Fife, Scotland, said: “Multiplexing for syndromic testing is really on the horizon for many, many laboratories at the moment. Particularly because the users, the clinicians, can see this as something that speeds up the patient experience in hospital and reduces in-patient costs significantly because of the speed of the return of the results.”

Dr. Ron Opstelten, Consultant for Biotechnology & Diagnostics, Nijmegen, The Netherlands, was similarly impressed, saying: “It’s very well done. Very good technology, spot on. It’s very fast, and I think it will have a very, very good place in the market.”

“It’s very well done. Very good technology, spot on. It’s very fast, and I think it will have a very, very good place in the market.”
Dr. Ron Opstelten, Consultant for Biotechnology & Diagnostics, Nijmegen, The Netherlands

So what is next for the QIAstat-Dx? A new panel currently in development will further expand the device’s capabilities. It will test for both meningitis and encephalitis. The former is a potentially deadly infection of the protective membranes surrounding the brain and spinal cord that is caused by several different viruses and bacteria. Encepahlitis is a rare inflammation of the brain which is also potentially life-threatening.

Once again, the QIAstat-Dx will provide a fast diagnosis for patients displaying common yet non-specific symptoms. This will speed up treatment times – and potentially save lives.

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