On February 23, 2017, the FDA cleared the expanded use of the Vidas Brahms PCT Assay to help health care 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. 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 lower respiratory tract infections.
“Unnecessary antibiotic use may contribute to the rise in antibiotic-resistant infections,” said Alberto Gutierrez, Ph.D., 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.”
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.
Sepsis can be part of the body’s response to an infection and can lead to tissue damage, organ failure, and death. Lower respiratory tract infections include community-acquired pneumonia, acute bronchitis, and acute exacerbations of chronic obstructive pulmonary disease (COPD). Bacteria often cause sepsis and lower respiratory tract infections, but viruses (particularly for lower respiratory tract infections) and non-infectious 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 this test to help clinicians better predict a patient’s risk of dying or becoming sicker due to sepsis.
The Vidas Brahms test is intended to be used in the hospital or emergency room. Risks associated with use of the test may 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. Health care providers and laboratorians should review the test’s package insert for complete information regarding appropriate clinical use and test performance.
See the FDA Announcement
See also Medical Law Perspectives, December 2015 Report: Pneumonia Complications, Hospitalizations, Deaths: Risks and Liabilities
See also Medical Law Perspectives, April 2015 Report: COPD Liability Risks: When Taking a Breath Is Not Easy
See also Medical Law Perspectives, March 2014 Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood - The Liability Risks
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication