The FDA has cleared the expanded use of the Vidas Brahms PCT Assay to help healthcare providers determine if antibiotic treatment should be started or stopped in patients with lower respiratory tract infections, such as community-acquired pneumonia, and stopped in patients with sepsis. The Vidas Brahms test is manufactured by bioMérieux Inc (Marcy l’Etoile, France). The test is intended to be used in the hospital or emergency room.
This is the first test to use procalcitonin (PCT), a protein associated with the body’s response to a bacterial infection, as a biomarker to help make antibiotic management decisions in patients with these conditions.
The test works by measuring PCT. High levels of PCT suggest a bacterial infection, while low levels suggest a viral infection or non-infectious causes. Clinicians may be able to use PCT and other information to safely withhold or stop antibiotics. Because PCT may indicate the presence of a variety of bacterial infections, it does not detect the exact cause of a patient’s symptoms.
Data supporting the test’s expanded use included clinical trial findings from published literature that compared PCT-guided therapy to standard therapy. Data from these prospective, randomized studies showed a significant decrease in antibiotic use for patients who had received PCT-guided therapy, without significantly affecting safety.
“Unnecessary antibiotic use may contribute to the rise in antibiotic-resistant infections,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. “This test may help clinicians make antibiotic treatment decisions.”