FDA Expands Use of Procalcitonin Test to Help Guide ABX Use

Megan Brooks

February 24, 2017

The US Food and Drug Administration (FDA) has cleared the expanded use of the Vidas Brahms procalcitonin (PCT) test to help clinicians determine whether antibiotic treatment should be initiated or stopped in patients with lower respiratory tract infections and stopped in patients with sepsis.

The Vidas Brahms PCT assay, manufactured by bioMérieux Inc, Marcy l'Etoile, France, is the first test to use the PCT protein to help guide antibiotic management decisions in patients with these conditions, the agency notes.

"Unnecessary antibiotic use may contribute to the rise in antibiotic-resistant infections. This test may help clinicians make antibiotic treatment decisions," Alberto Gutierrez, PhD, director, Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health, said in a statement.

High levels of PCT suggest a bacterial infection, whereas low levels suggest a viral infection or noninfectious causes, the FDA says. Clinicians may be able to use PCT levels and other information to safely withhold or discontinue antibiotics. PCT may indicate the presence of a variety of bacterial infections, but it does not detect the exact cause of a patient's symptoms.

The Vidas Brahms PCT assay is already approved by the FDA to help clinicians better predict a patient's risk of dying from sepsis or of their condition worsening.

The FDA cleared expanded use of the test to help clinicians assess whether antibiotic treatment should be started or stopped in patients with lower respiratory tract infections and stopped in patients with sepsis. The decision was based on 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," the FDA says.

The Vidas Brahms PCT test is intended for use in the hospital or emergency department. "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," the FDA cautions.

They say healthcare 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. Healthcare providers and laboratory technicians should review the test's package insert for complete information regarding appropriate clinical use and test performance, they advise.

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