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FDA clears Lumipulse G Brahms PCT Assay

June 21, 2018Fujirebio Diagnostics received FDA clearance of its Lumipulse G Brahms PCT Assay for testing on its Lumipulse G1200 immunoassay platform. The assay is a chemiluminescent enzyme immunoassay for the quantitative determination of procalcitonin in human serum and plasma and offers excellent precision with a CV of ≤4.7 percent.

“Serial measurement of procalcitonin levels is a significant innovation for antibiotic stewardship, which can lead to reduced hospitalization stays without adversely affecting patient outcomes,” Matthew Bell, VP of sales and marketing at Fujirebio US, said in a press release. “The Lumipulse G Brahms PCT Assay is a significant new tool in the fight against sepsis, lowering hospital readmission rates and improving the use of antibiotic treatment.”

Procalcitonin is a biomarker specific to bacterial infections and can aid in the decision-making for guiding antibiotic treatment or to assess the risk of critically ill patients for progression to sepsis or septic shock.

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