VIDAS® PCT™ - the first FDA-approved procalcitonin test

BioMérieux's VIDAS® B • R • A • H • M • S PCT ™ became the first procalcitonin test approved by the FDA as an aid test for antibiotic management in respiratory and bacteremia

BioMérieux's VIDAS® B • R • A • H • M • S PCT™ became the first procalcitonin test to be FDA-approved as an aid test for antibiotic management in respiratory and bacteremia

BioMérieux, a pioneer in the field of in vitro diagnostics, has received 510(k) certification from the US Food and Drug Administration (FDA) for the widespread use of VIDAS® B • R • A • H • M • S PCT™, the automated procalcitonin test (PCT), helps clinicians make important decisions about antibiotic use in two common clinical situations: urinary tract infections. lower respiratory tract infection (LRTI) and sepsis.

With these two new additions, VIDAS® B PCT™ becomes the first and only FDA-approved procalcitonin test in the U.S. market to assist physicians in antibiotic management of suspected patients. LRTI or confirmed LRTI or sepsis. In the case of patients with LRTIs, VIDAS® B • R • A • H • M • S PCT will assist physicians in making decisions to safely reduce antibiotic use. In the case of a patient with sepsis, VIDAS® B • R • A • H • M • S PCT will help doctors decide when it is safe to stop taking antibiotics. Using VIDAS® B • PCT™ in these common and important clinical situations will help to reduce inappropriate and unnecessary antibiotic use, possibly avoiding side effects associated with use them while slowing down and preventing the emergence of bacterial drug resistance.

"We are honored to receive this innovative certification. Antibiotic resistance is considered a major threat to public health, and the FDA certification demonstrates our ability to provide clinicians with ready tests of high medical value to help them make important treatment decisions.” Mark Miller, BioMérieux Vice President of Health, says: “Our goal is to achieve results. better for the patient and ensure that each person receives the appropriate treatment.

True to its pioneering spirit, bioMérieux worked with the FDA to develop a strategy to comprehensively review published literature and conduct in-depth analysis, known as meta-analysis. These studies confirm the important role of VIDAS® B • R • A • H • M • S PCT™ as an aid to antibiotic control and the important role that diagnostic tests play. to limit the proliferation of multidrug-resistant bacteria" Bozzette, BioMérieux's Department of Health for the Americas.

Originally inspected by the FDA in 2007, VIDAS® B PCT™ was the first automated test measuring procalcitonin in the United States to help assess the risk of sepsis and septic shock on the first day after in-unit admission. intensive care unit (ICU). In June 2016, this trial was approved by the FDA to assess the risk of death for patients with severe sepsis by monitoring PCT levels continuously over 96 hours.

About VIDAS®

The VIDAS® automated immunoassay system, designed for small test lines, is suitable for emergency situations. The wide menu of tests allows clinicians to provide diagnosis, monitoring and prediction of a number of diseases, particularly in the field of infectious diseases and emergency testing. Among them, VIDAS® B • R • A • H • M • S PCT provides test results in just 20 minutes.

Information about lower respiratory tract infections

Lower respiratory tract infections (LRTIs), common in all age groups. In 2013, there were approximately 150 million LRTI reports. The result was 2.7 million deaths, accounting for 4.8% of all deaths in 2013. LRTIs are among the leading causes of hospital admissions after emergency room visits and include associations. community-acquired pneumonia (CAP) Acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD). These three conditions are often treated with antibiotics, although the majority are for reasons that do not require the use of antibiotics.

Introduction to sepsis

Sepsis is a serious infection in which the human immune response leads to vital organ dysfunction. About 27 million people in the world are affected by infections each year. The most severe form, septic shock, has a mortality rate of 30%. Diagnosing as quickly as possible, identifying and treating the most appropriate antibiotic therapy, and knowing when to safely stop antibiotics helps reduce antibiotic use while improving patient outcomes.

BioMérieux's commitment to fighting infections

VIDAS® B • R • A • H • M • S PCT is one of BioMérieux's bacteremia solutions. BioMérieux enables workflow optimization, allowing sepsis patient samples to reach the laboratory and be analyzed rapidly. The solution includes: blood cultures with BacT/ALERT® or BacT/ALERT® VIRTUO™, a fully automated, CE-marked blood culture system that makes receiving and handling emergency samples possible. 24/7; FilmArray® BCID molecular biological solution, received within 1 hour and only 2 minutes to implement, allows pathogen identification; VITEK® MS for rapid identification of pathogens using the MALDI-TOF spectrometer; And VITEK® 2 for pathogen identification and antibiotic susceptibility testing.