The FDA has given the green light to expanded use of the Vidas Brahms PCT assay (bioMérieux Inc.) to help health care providers determine whether antibiotic treatment should be started or stopped in patients with lower respiratory tract (LRT) infections, such as community-acquired pneumonia, and stopped in patients with sepsis. 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, whereas low levels suggest a viral infection or noninfectious 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.
Sepsis can be part of the body’s response to an infection and can lead to tissue damage, organ failure, and death. LRT infections include community-acquired pneumonia, acute bronchitis, and acute exacerbations of chronic obstructive pulmonary disease (COPD). Bacteria often cause sepsis and LRTs, but viruses (particularly for LRT infections) and noninfectious diseases can cause similar symptoms.
The Vidas Brahms test was cleared through the 510(k) pathway, a regulatory pathway for certain medical devices that are substantially equivalent to a legally marketed predicate device. The FDA first cleared the test to help clinicians better predict a patient’s risk of dying or becoming sicker due to sepsis.
Data supporting the test’s expanded use included clinical trial findings from published literature that compared PCT-guided therapy with standard therapy. Data from these prospective, randomized studies showed a significant reduction in antibiotic use in patients who had received PCT-guided therapy, without significantly affecting safety.
The Vidas Brahms assay is intended to be used in hospitals or emergency departments. Risks associated with use of the test include false positive results, which may lead to unnecessary treatment with antibiotics, and false negative results, which may lead to a delay in the selection of appropriate therapy. Health care providers should not rely solely on PCT test results when making treatment decisions, but should interpret test results in the context of a patient’s clinical status and other laboratory results.
Source: FDA(link is external); February 23, 2017.
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