Cross‐sectional reassessment after 4 years of clinical routine use of AQUIOS CL for absolute T cell quantitation in a university hospital. Issue 5 (19th April 2022)

• Record Type: Journal Article
• Authors: Lemoine, Léa; Malcus, Christophe; Poitevin‐Later, Françoise; Venet, Fabienne; Monneret, Guillaume; Gossez, Morgane
• Is Part Of: Cytometry. Volume 102:Issue 5(2022)
• Page Start: 390
• Page End: 399
• Publication Date: 2022-04-19
• Subjects: accreditation -- aquios CL -- flow cytometry -- standardization -- T cell; Flow cytometry -- Diagnostic use -- Periodicals; Cytodiagnosis -- Periodicals; 616.07582
• DOI: 10.1002/cyto.b.22069
• Languages: English
• ISSNs: 1552-4949

Abstract

Abstract: Background: We had previously reported appropriate performances of automated AQUIOS CL cytometer (Beckman Coulter) for regulatory approval of absolute T cell enumeration. However, after 4 years of routine use, we still observed recurrent histogram anomalies that may affect both absolute values and T cell subset percentages results. The objective of the current study was thus to perform a cross‐sectional evaluation of these graphical anomalies within a university hospital context, to assess their influence on results and ultimately to propose a standardized decision tree to circumvent graphical disturbances at the time of results validation. Methods: Eight hundred and sixty‐two blood samples were prospectively analyzed on AQUIOS CL. Results were compared to (i) lymphocyte values from complete blood count; (ii) results from manual staining and analysis on Navios cytometer (Beckman Coulter); (iii) results after washing step and reacquisition on AQUIOS CL. Results: Nearly 75% analyses did not show any graphical anomaly. 20% had single anomaly on "Lymphs (45)" or "Lymphs EV" regions influencing T cells percentages and requiring manual re‐gating of "CD3− capture" region. 5% showed concomitant "Lymphs EV" and "Lymphs (45)" anomalies influencing both T cell percentages and absolute counting and requiring additional staining and analysis on Navios. Finally, <1% presented with anomaly on "CD4/CD8" histogram or "CD3+ All" region, influencing both T cell percentages and absolute counting. Conclusions: Around 25% AQUIOS CL results were flawed due to gating anomalies. In <5% cases, additional back‐up procedures should be undertaken to ensure results validity. A simple decision‐tree may help in guiding validation process.