Bayer Diagnostics has received U.S. Food and Drug Administration (FDA) clearance for its Cerebrospinal Fluid (CSF) assay automated on the Advia 120 hematology system. This is first FDA cleared automated assay for spinal fluid analysis on a routine hematology analyzer. CSF testing provides results that may aid physicians in evaluating a variety of conditions including meningitis, encephalitis, neurological disorders, cerebral hemorrhage and some types of leukemia.

"Until now, CSF testing has been subject to manual variability and has been one of our most labor intensive tests," said Timothy Flaming, supervisor at St. Mary's Medical Center, Long Beach, CA. "In addition to providing more precise test results, the availability of this automated test will allow us to deliver more timely results to physicians making critical therapy and disease management decisions."

Conventional hematological CSF analysis requires laboratories to use manual methods that are time and labor intensive, requiring 30-45 minutes to complete, and can be subject to technician variability.

With the CSF test automated on the Advia 120 system, results are available in less than 5 minutes and eliminate hands-on sample management reducing the potential for operator error. The FDA cleared assay provides an in vitro diagnostic, quantitative determination of blood cells in CSF specimens. In addition, the Advia 120 cerebrospinal fluid (CSF) method provides leukocyte (WBC) and erythrocyte (RBC) counts along with both absolute and proportional counts for the WBC differential.

"Bayer Diagnostics is committed to providing technology that enhances value to the laboratory and contributes to patient care," said Hans Hiller, senior vice president, Bayer Diagnostics' Laboratory Testing Segment. "The FDA clearance is good news for laboratories and physicians. Now laboratories can automate this important diagnostic test and provide physicians greater confidence in their results, leading to more timely disease management decisions."

The Advia 120 Hematology System, established worldwide as a state-of-the-art laboratory system, is designed to assist healthcare professionals to monitor patients with cancer, kidney disease and anemia. This system allows laboratory professionals to perform routine blood tests, such as a complete blood count, white blood cell differential and reticulocyte analysis.

The Advia 120 hematology system CSF assay benefits include excellent specificity and sensitivity, as well as automated testing on a system with proven reliability and precision, improved accuracy of reported results and turnaround time providing improved efficiencies to the laboratory.