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FDA clears two tests used to assist treatment decisions for infections, sepsis

FDA clears two tests used to assist treatment decisions for infections, sepsis
February 24, 2017

The FDA recently approved the expanded use of the Vidas Brahms PCT Assay, which guides antibiotic treatment decisions for patients with lower respiratory tract infections and sepsis, and authorized the marketing of the PhenoTest BC Kit, which is the first test of its kind to identify organisms that cause bloodstream infections and provide information on their susceptibility to antibiotics.  

The new indications for the Vidas Brahms PCT Assay (bioMérieux Inc.) allow health care providers in hospitals and EDs to determine whether an antibiotic should be started or stopped in patients with lower respiratory tract infections, and stopped in patients with sepsis. It is the first test to use procalcitonin (PCT), a biomarker indicating the body’s response to bacterial infections.

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