Fujirebio Diagnostics Inc, Malvern, Penn, has received FDA premarket notification (510(k)) clearance of the company’s Lumipulse G Brahms PCT assay for use on the Lumipulse G1200 immunoassay platform. Procalcitonin (PCT) is a biomarker specific to bacterial infections. PCT monitoring is advantageous for guiding antibiotic treatment decisions or assessing the risk of critically ill patients for progression to sepsis or septic shock.

When used in conjunction with other laboratory findings and clinical assessments, the Lumipulse PCT assay can assist with a range of diagnostic and treatment processes, including:

  • Decisionmaking for patients with suspected or confirmed lower respiratory tract infection.
  • Risk assessment of critically ill patients for progression to severe sepsis or septic shock, on their first day of admission to an intensive care unit (ICU).
  • Measuring the change in PCT levels over time, to assess 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.
  • Decisionmaking for patients with suspected or confirmed sepsis.

Matthew Bell, Fujirebio.

According to company information, the Lumipulse PCT assay is a precise test, with a CV of ?4.7%. With such an assay, clinicians can more accurately determine changes in PCT levels, indicating the effectiveness of antibiotics, and thereby make more-informed decisions about the initiation or discontinuation of antibiotic therapy. By removing the analytical variability of test results when monitoring antibiotic therapy, the Lumipulse PCT assay helps clinicians conform to the new guidelines for antibiotic stewardship 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 of sales and marketing at Fujirebio. “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.”

To learn more, visit Fujirebio.