DiaSorin Molecular is part of the DiaSorin Group, which is an Italian multinational company and a global leader in the market of in vitro diagnostics. For over 40 years, the group has been developing, producing and commercialising diagnostics tests for a wide range of clinical areas including paediatrics, oncology, women's health and infectious diseases.
In 2016, DiaSorin acquired the molecular business of Focus Diagnostics to expand into the molecular diagnostics market. The DiaSorin Molecular portfolio includes Simplexa kits for infectious disease, and more than 55 primer pairs and general purpose reagents. Most Simplexa kits are developed as direct assays, requiring no sample extraction and providing results in about an hour.
"Pertussis can be detected among all age groups - neonates, children, adolescents and adults, and so on. However, it primarily affects children less than six months old with severe clinical symptoms that typically result in admission to intensive care units."
Simplexa products are designed for use on the LIAISON MDX, a real-time PCR instrument that has the capability of running either an 8-well or 96-well disc, providing an ideal platform to accommodate low and high-volume testing needs. This allows users to leverage the system's flexibility and scalability to handle most laboratory challenges.
The latest DiaSorin Molecular product to launch is the Simplexa Bordetella Direct kit, receiving CE marking and FDA clearance in 2017 and 2018 respectively. The assay allows for the detection and discrimination of Bordetella pertussis and Bordetella parapertussis directly from nasopharyngeal swabs in a range of sample transport media. It is a CLIA moderate complexity assay that improves efficiency with a true sample-to-answer workflow without DNA extraction in about an hour.
Pertussis, commonly called whooping cough, is a highly contagious disease of the respiratory system caused by small Gram-negative bacteria, mainly B. pertussis and B. parapertussis. Clinically, it presents with a prolonged cough illness and patients often have episodes of violent coughing that may be followed by an inspiratory whoop.
The World Health Organisation estimates that there are 50 million whooping cough cases worldwide each year, resulting in 350,000 deaths. Pertussis can be detected among all age groups - neonates, children, adolescents and adults, and so on. However, it primarily affects children less than six months old with severe clinical symptoms that typically result in admission to intensive care units. A great majority of these cases are caused by B. pertussis - however, up to 20% of cases are caused by B. parapertussis.
Molecular testing for Bordetella detection speeds up diagnosis by up to seven days after symptoms occur compared with culture testing, due to its faster turnaround time and higher sensitivity. Timely diagnosis guides antibiotic treatment that can mitigate symptoms and prevent transmission. This is especially critical for early diagnosis and treatment in patients less than three months old.
The Simplexa Bordetella Direct assay provides a quick and reliable result for early decision-making, treatment and improvement of patient care. DiaSorin Molecular also provides a comprehensive list of molecular diagnostic assays, including HSV, VZV, respiratory syncytial virus (RSV), influenza A&B, Group A Streptococcus, and Group B Streptococcus.