Evaluation of analytical performance of AQUIOS CL flow cytometer and method comparison with bead-based flow cytometry methods.

in Clinical chemistry and laboratory medicine by Andrada S Chiron, Lucy Locher, Aurélie Sarthou, Aude Gleizes, Roman Krzysiek, Pascale Chretien, Salima Hacein-Bey-Abina

TLDR

  • The study looked at how well a new machine called the AQUIOS CL system works at counting different types of cells in the blood. The study compared the AQUIOS CL system with two other methods of counting cells, and found that the AQUIOS CL system worked well and was similar to the other methods. However, the study also found that there were some limitations to the AQUIOS CL system that needed to be addressed. The study suggests that the DxFLEX flow cytometer can be used as a backup system in case the AQUIOS CL system doesn't work properly or if there is a problem with the equipment. The study also highlights the importance of making sure that new machines are tested to make sure they work correctly before they are used in hospitals or clinics.

Abstract

Given that method validation is mandatory for compliance with the International Organization for Standardization (ISO) 15,189 standard requirements, we evaluated the analytical performance of the AQUIOS CL system (Beckman Coulter) and compared it with two bead-based flow cytometry (FCM) protocols (BD FACSCAntoII and Beckman Coulter DxFLEX). There are no comparative literature data on standardized protocols for counting lymphocyte subsets on the new-generation cytometer DxFLEX. We evaluated the AQUIOS CL's performance with regard to accuracy, linearity and stability by using dedicated control cell samples and patient samples. We also compared the lymphocyte counts measured on the AQUIOS CL (n=69 samples) with those measured on the BD FACSCAntoII and DxFLEX FCM systems. For 61 samples, FCM results were compared with those measured on the XN-3000 Sysmex hematology analyzer. AQUIOS CL showed acceptable performance - even outside the manufacturer's quantification ranges- and strong correlations with bead-based FCM methods. The FCM techniques and the XN-3000 gave similar absolute lymphocyte counts, although values in samples with intense lymphocytosis (B cell lymphoma/leukemia) were underestimated. The AQUIOS CL flow cytometer is a time-saving, single-platform system with good performance, especially when the manufacturer's instructions for use are followed. However, AQUIOS CL's possible limitations and pitfalls impose validation of a bead-based FCM method for immunophenotyping verification or as a back-up system. Although the DxFLEX flow cytometer is more time-consuming to use, it can provide standardized lymphocyte subset counts in case of aberrant results on AQUIOS CL or in the event of equipment failure.

Overview

  • The study evaluated the analytical performance of the AQUIOS CL system (Beckman Coulter) and compared it with two bead-based flow cytometry (FCM) protocols (BD FACSCAntoII and Beckman Coulter DxFLEX).
  • The study aimed to assess the accuracy, linearity, and stability of the AQUIOS CL system and compare it with the two bead-based FCM protocols in terms of lymphocyte counts.

Comparative Analysis & Findings

  • The AQUIOS CL system showed acceptable performance, even outside the manufacturer's quantification ranges, and strong correlations with bead-based FCM methods. The FCM techniques and the XN-3000 Sysmex hematology analyzer gave similar absolute lymphocyte counts, although values in samples with intense lymphocytosis (B cell lymphoma/leukemia) were underestimated. The DxFLEX flow cytometer is more time-consuming to use but can provide standardized lymphocyte subset counts in case of aberrant results on AQUIOS CL or in the event of equipment failure.

Implications and Future Directions

  • The study highlights the importance of validating new-generation cytometers for compliance with the ISO 15,189 standard requirements. The findings suggest that the AQUIOS CL system is a time-saving, single-platform system with good performance, especially when the manufacturer's instructions for use are followed. However, validation of a bead-based FCM method for immunophenotyping verification or as a back-up system is necessary to address the possible limitations and pitfalls of the AQUIOS CL system. The DxFLEX flow cytometer can provide standardized lymphocyte subset counts in case of aberrant results on AQUIOS CL or in the event of equipment failure. Future research should focus on developing standardized protocols for counting lymphocyte subsets on the new-generation cytometer DxFLEX.
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