ADORE: the performance characteristics of five automated platforms in the analysis of urinary dysmorphic erythrocytes and pathological casts
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Jolien J. Luimstra
,
Xue D. Manz
,
Rüya G. Koçer
,
Hilde H.F. Remmelts
,
Dorien M. Rotteveel
Abstract
Objectives
Automated urine particle analyzers are increasingly employed in clinical laboratories to standardize urinalysis. These systems can reduce workload, turnaround time and the inter-observer variation. This study aimed to assess the performance of five automated urine particle analyzers in detecting and categorizing dysmorphic erythrocytes (isomorphic-, dysmorphic erythrocytes, acanthocytes) and pathological casts, in particular erythrocyte casts, for screening of glomerular vs. non-glomerular hematuria, compared to manual phase-contrast microscopy, as the reference method.
Methods
The analytical performance of five automated urine particle analyzers, Atellica UAS 800, FUS-3000Plus, iQ200, SediMAX conTRUST Pro, and UF-4000, for measuring and categorizing erythrocytes and pathological casts was evaluated. Urine samples spiked with erythrocytes were used to assess precision and performance characteristics, while 68 urine samples from patients with glomerular hematuria were analyzed for concordance.
Results
Automated analyzers demonstrated acceptable precision at middle and high erythrocyte concentrations. At low levels, the iQ200 performed relatively well and the SediMAX met the manufacturer’s precision criteria. Manual on-screen review was required for 90 % of samples analyzed to achieve acceptable results for dysmorphic erythrocytes and cast detection. None of the analyzers exhibited strong agreement with manual microscopy for identifying isomorphic-, dysmorphic erythrocytes or acanthocytes (concordance <0.80), whereas the FUS-3000 and UF-4000 had relatively higher sensitivities for pathological cast detection (58.6 and 69.6 %, respectively).
Conclusions
Current automated urine particle analyzers are limited in accurately identifying dysmorphic erythrocytes and pathological casts, necessitating manual microscopy for reliable assessment. While automation offers potential for standardization and efficiency, significant technological advancements are required to improve diagnostic accuracy, reliability, and clinical applicability.
Funding source: The Foundation Quality Funds for Medical Specialists
Award Identifier / Grant number: SKMS, project number 55092985
Acknowledgments
We would like to express our gratitude to Analis, Beckman Coulter and Menarini for providing their analyzers (FUS-3000Plus, iQ200 and SediMAX conTRUST Pro, respectively) at our disposal. We also would like to thank the members of the Clinical Chemistry Society of the Netherlands (NVKC) workgroup Guideline ‘Unambiguous and accurate laboratory diagnostics in hematuria’ for their input and valuable discussions. We owe the laboratory staff of Meander Medical Centre, Mrs. Thea van der Valk-Rosendal in particular, many thanks for their indispensable practical support in obtaining and preparing samples.
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Research ethics: This study was approved by the Institutional Review Board for scientific research of Meander Medical Center, Amersfoort (TWO 19-104) and conducted in accordance with the Declaration of Helsinki (as revised in 2013).
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Informed consent: Informed consent was obtained from all individuals included in this study.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved submission.
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Use of Large Language Models, AI and Machine Learning Tools: None declared.
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Conflict of interest: The authors state no conflict of interest.
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Research funding: This work was supported by the Foundation Quality Funds for Medical Specialists (SKMS, project number 55092985).
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Data availability: Not applicable.
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Supplementary Material
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