The first CSF assay to be released for use on a routine haematology analyser has received clearance from the US Food and Drug Administration
Bayer Diagnostics has launched an automated method for the analysis of cerebrospinal fluid (CSF) using the Advia 120 haematology system.
This is the first CSF assay to be released for use on a routine haematology analyser, and has recently received clearance from the US Food and Drug Administration (FDA).
The Advia 120 CSF assay provides an in vitro diagnostic, quantitative determination of blood cells in CSF specimens, with excellent sensitivity and specificity.
It also provides leucocyte (WBC) and erythrocyte (RBC) counts along with both absolute and proportional counts for the WBC differential.
Results are available in less then five minutes, with automated sample handling minimising the potential for operator error. Traditionally, manual methods have been used for the purposes of cell counting and cell differentiation in CSF analysis.
These conventional methods are both time-consuming and labour intensive, taking 30-45 minutes per sample - and they are subject to operator variability.
By contrast, automating CSF analysis on the Advia 120 offers laboratories significant advantages in terms of standardisation and time savings using a system whose reliability and precision are well proven.
In addition to improving accuracy, the new assay will allow Advia 120 users to deliver more timely results to clinicians, who can then use them to make critical therapy and disease management decisions.
The results of CSF analysis can aid in the evaluation of a wide range of conditions, including meningitis, encephalitis, neurological disorders, cerebral haemorrhage and some types of leukaemia.
The performance of the CSF assay is quality assured through use of newly-developed TestPoint controls.
No changes to existing Advia 120 hardware or reagent configurations are necessitated by use of the method.
"Bayer is committed to providing technology that enhances the value of laboratories and contributes to patient care", says Sue Mead, marketing manager for haematology at Bayer Diagnostics.
"The introduction of this new assay means that laboratories can now automate CSF analysis, giving clinicians even greater confidence in the quality of results. This enhances the Advia 120's ability to get it right first time, every time."
