Product News: Fujirebio Diagnostics Announces FDA Clearance of Lumipulse PCT Assay for Bacterial Infections

Novel PCT assay to assist with antibiotic stewardship and risk assessment of respiratory tract infections or sepsis

12 Jun 2018


Fujirebio Diagnostics, Inc., a consolidated subsidiary of Miraca Holdings Inc., has received  U.S. Food and Drug Administration (FDA) clearance of the company’s Lumipulse® G B•R•A•H•M•S PCT Assay  for testing on its LUMIPULSE® G1200 immunoassay platform. 

Procalcitonin (PCT) is a biomarker specific to bacterial infections. PCT offers advantages as an aid to guide antibiotic treatment decisions or to assess the risk of critically ill patients for progression to sepsis or septic shock.

The Lumipulse G B•R•A•H•M•S PCT Assay, when run on the LUMIPULSE G1200 immunoassay platform, and used in conjunction with other laboratory findings and clinical assessments, can aid in:

  • Decision-making for patients with suspected or confirmed lower respiratory tract infection
  • Risk assessment of critically ill patients on their first day of intensive care unit (ICU) admission for progression to severe sepsis or septic shock
  • The cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU, or obtained in the emergency department or other hospital setting prior to ICU admission, by measuring a change in PCT level over time
  • Decision-making for patients with suspected or confirmed sepsis

The Lumipulse G B•R•A•H•M•S PCT Assay offers excellent precision with a CV of ≤4.7%. With a precise  assay, clinicians can more accurately determine the change in PCT levels and, therefore, the effectiveness of antibiotics, as well as make more informed antibiotic initiation and discontinuation decisions. By removing analytical variability of test results when monitoring antibiotic therapy, the Lumipulse G B•R•A•H•M•S PCT Assay helps conform to new guidelines for antibiotic stewardship as released by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America.

“Serial measurement of procalcitonin levels is a significant innovation for antibiotic stewardship, which can lead to reduced hospitalization stays without adversely affecting patient outcomes,” says Matthew Bell, Vice President Sales and Marketing at Fujirebio, US. “The Lumipulse G B•R•A•H•M•S PCT Assay is a significant new tool in the fight against sepsis, lowering hospital re-admission rates, and improving the use of antibiotic treatment.”