FDA Clears AQUIOS CL Flow Cytometer For Routine Immunophenotyping Applications in US Clinical Labs

Beckman Coulter’s new, automated AQUIOS CL Flow Cytometer has received clearance from the U.S. Food and Drug Administration (FDA) for use in the clinical laboratory.

The small footprint, high precision ‘LOAD & GO’ instrument has been designed specifically for the Lean laboratory, operating 24/7 and requiring automated systems which improve workflow, enhance quality and deliver a consistent turnaround time (TAT). Easy to operate with integrated automated sample preparation like a hematology analyzer, Aquios CL Flow Cytometer delivers first results within 20 minutes for routine applications such as immunophenotyping. Subsequent results are available at a rate of 25 samples per hour for up to a full 96-well plate.

Mario Koksch, Vice President and General Manager of Beckman Coulter’s Cytometry Business Unit explained: “The AQUIOS CL Flow Cytometer technology transforms the way routine applications such as immunophenotyping are managed by the clinical lab. The precision of the AQUIOS CL Flow Cytometer in establishing the lymphocyte gate makes it possible to carry out high volume, T, B, and NK cell analysis within the hospital lab instead of an external lab.

“The high level of automation helps prevent sample processing errors and frees up experienced staff for more complex analysis, making better use of staff resources. In addition, by removing manual processes, the instrument delivers operational savings and increases overall workflow.”

Once samples are loaded, the instrument automatically carries out mixing, cap piercing, sample preparation, and analysis. Its automated cap-piercing technology helps reduce staff exposure to biohazardous samples. Dr Koksch added: “Today’s Lean laboratory requires instrumentation that also offers staff safety features alongside efficiency and lower costs.”

The fully integrated system includes a 40-tube capacity autoloader able to handle a variety of tube sizes, with continuous, random loading and unloading. There is a separate single-tube loader for STAT samples. Sample preparation, reagent monitoring, barcode scanning and LIS connectivity are all automated.

Intuitive software also makes the system fast and easy to use. ‘SmartTrack reagent monitoring’ tracks reagent use and test progress, with barcode tracking eliminating manual quality control and reagent logs. If the QC fails, the system automatically alerts the operator by text message or email for intervention.

The first tests available are Tetra-1 (CD45/4/8/3), Tetra-2+ (CD45/56+16/19/3), and Tetra Combo (both Tetra-1 and -2+) for immune status monitoring. For the Tetra application, the first result is available in approximately 20 minutes from loading (measured with Tetra-1 or Tetra-2+), with subsequent results delivered at the rate of 25 samples per hour, for up to a full 96 well plate (measured with Tetra Combo).

Image Caption: 'Routine clinical tests such as immunophenotyping can be run in the clinical lab using the new AQUIOS CL flow cytometer from Beckman Coulter Life Sciences’.