What a tragic irony – an otherwise healthy person goes into a healthcare facility for a routine procedure and contracts a potentially fatal infectious disease. Millions of patients worldwide are being affected by healthcare-associated infections (HAIs) every year, leading to mortality and financial losses. Automated molecular diagnostics systems such as QIAGEN’s QIAsymphony RGQ and portfolio of artus diagnostic assays are enabling hospitals to better control HAIs and make infection control more effective.
A hushed voice rises from a discussion among physicians and nurses on the patient ward of a hospital, the group discussion using medical terms like “MRSA” or “C. diff” that are essentially shorthand for a crisis: A serious infectious disease is suspected in a patient who needs life-saving diagnosis and treatment along with costly isolation procedures to contain the outbreak.
“Healthcare-associated infections are a major problem in the United States and just simply everywhere around the world. These pathogens cause a lot of misery for patients, with mortality rates as high as 20%. Then there’s the financial impact since the costs of care can run to more than $100,000 for just one severe case,” says Dr. Lance R. Peterson, Director of Microbiology and Infectious Diseases Research at NorthShore University HealthSystem in suburban Chicago, considered a leader in HAI screening and control strategies.
The issue of HAIs does not discriminate among the rich or poor, or among emerging markets or industrialized countries. Of every 100 hospitalized patients at any given time, the World Health Organization (WHO) estimates that seven in developed and 10 in developing countries will acquire at least one HAI. These involve acronyms that have become part of everyday conversations such as MRSA (methicillinresistant Staphylococcus aureus), C. diff (Clostridium difficile),Van R (Vancomycin-resistant Enterococci) and a “superbug” called CRE (Carbapenem-resistant Enterobacteriaceae). The economic burden is estimated at $ 10 billion in the United States and $ 7 billion in Europe. In low-resource regions, HAIs pose an even tougher challenge.
“Historically, when a patient’s symptoms raised suspicion of C. difficile or another HAI, the doctor wrote an order for a test and a sample went to the lab for a bacterial culture or enzyme immunoassay. The result took at least a day, sometimes even two or three days, to come back. Molecular diagnostic tests have changed that, providing results in just a few hours and making an impact on how we can better care for patients,” Dr. Peterson says.
The potential to save lives and make a difference in hospitals and nursing homes prompted QIAGEN to create a dedicated team in 2012 to develop and commercialize a portfolio of artus diagnostic assays targeting a broad range of HAIs and performed on the QIAsymphony RGQ automation platform. “
We decided to add healthcare-associated infections to the QIAsymphony content menu because HAIs pose a major threat to our healthcare system – both an economic threat and a threat to the lives of patients,” says Dr. Andreas Schaefer, Vice President, Infectious Diseases Program Management at QIAGEN. “We knew we could develop assays that addressed weaknesses in the existing methods, to help contain these serious infections.”
QIAGEN is now helping healthcare providers control HAIs with advanced molecular tests for diagnosing suspected HAIs as well as preventive screening. In 2014, QIAGEN launched the FDA-cleared artus C. difficile test in the United States. In Europe, artus tests for C. diff and MRSA are available with CE-IVD marking, with more tests in clinical development.
In addition to pioneering the proactive screening of incoming patients to reduce the hospital’s own HAI rate, Dr. Peterson’s lab at NorthShore has conducted research as part of the U.S. regulatory clearance process for many new diagnostic tests. He says the QIAsymphony RGQ MDx performed well in recent clinical trials involving the artus tests for detection of C. difficile infections as well as tests for two other infectious diseases.
Adding HAIs to QIAsymphony’s testing menu – which also includes diagnostics for blood-borne viruses, monitoring of transplant patients, and for personalizing treatments for cancer patients – makes the automation platform very economically viable for many clinical labs.
“The clinical need in healthcare-associated infections is driving dissemination of molecular testing into small and mid-sized hospitals. They are switching to molecular diagnostics from traditional methods because they need rapid, accurate results to optimize care and contain these infections,” says Gosia Leitch, Global Product Manager, Infectious Diseases.