In vitro diagnostics modules for CD4 monitoring and stem cell monitoring, both validated and featuring algorithms for automatic gating, expand the clinical application of flow cytometry system
Beckman Coulter announces two new clinical applications for its FC 500 flow cytometer - TetraCXP for CD4 monitoring, and StemCXP for stem cell monitoring.
Both of these proprietary applications are validated for in vitro diagnostic use and feature algorithms for automatic gating.
The FC 500 flow cytometer with CXP software, introduced to the clinical market in 2004, brought the FC 500 platform from the life science and clinical research segments into the clinical diagnostics laboratory.
It offers Windows-based operation and many usability advancements along with LIS (laboratory information system) connectivity and expanded QC functionality.
CXP software allows plug-in modules, the first of which are the Tetra and Stem applications.
The TetraCXP application, with TetraChromet reagents, is a well-established, fully automated IVD method for enumeration of CD4 positive cells - a critical component of HIV monitoring.
The TetraCXP automatically gates the targeted cell population for simplified and accurate counts, and includes an automated QC program which monitors daily instrument calibration.
Automated panel reports, for one- or two-tube CD4 assays, provide easy-to-read, single-page summaries of calculated results.
A built-in database enables the tracking of patient populations and trends while storing data for subsequent analyses.
The stemCXP application monitors stem cells by providing absolute enumeration of CD34+ positive hematopoietic progenitor cells.
It is said to be the first flow cytometry application for stem cell monitoring that follows International Society for Cellular Therapy (formerly ISHAGE) guidelines.
It allows automated gating for walkaway operation, or the option to manually adjust gates for each sample.
The system includes stemCXP software for the FC 500 flow cytometer and Stem-Kit reagents, including a true negative control and absolute count reagent.
Sample identification information can be downloaded and uploaded from the laboratory information system, for increased efficiency with reduced transcription errors.
"As flow cytometry research moves into the clinical environment, ease of use and quality control monitoring are essential," explained Bill Watkins, marketing manager flow cytometry for Beckman Coulter.
"The new FC 500 with CXP technology, along with the newly released CXP IVD modules, provide an integrated simplified solution to the growing clinical market".