Assessing Intra- and Inter-Analyzer Imprecision in Automated Hematological Laboratories

Imprecision of hematological analyzers

  • Laura Pighi Section of Clinical Biochemistry, University of Verona, Verona, Italy
  • Marco Tosi Section of Clinical Biochemistry, University of Verona, Verona, Italy
  • Mariateresa Rizza Section of Clinical Biochemistry, University of Verona, Verona, Italy
  • Gian Luca Salvagno Section of Clinical Biochemistry, University of Verona, Verona, Italy
  • Giuseppe Lippi
DOI: https://doi.org/10.5937/jomb0-62919
Keywords: Laboratory hematology, Automation, Imprecision

Abstract


Background: Reliable hematology results are crucial for patient diagnosis and monitoring. Maintaining low variability is particularly important for key parameters like hemoglobin, white blood cells, and platelets, especially in automated laboratory workflows where multiple hematological analyzer are connected within the same line.

Methods: Two residual whole blood samples, one normal and one pathological, were analyzed in ten consecutive replicates on a Sysmex XN-10 analyzer (XN‑1) and then on a second connected analyzer (XN‑2). Intra-analyzer and inter-analyzer imprecision were calculated as coefficients of variation (CV%).

Results: Intra-analyzer CVs for the normal sample ranged from 0.3% for hemoglobin to 1.5% white blood cells, while inter-analyzer CVs remained below 2%. For the pathological sample, intra-analyzer CVs were 0.3–1.0%, and inter-analyzer CVs reached up to 2.1% for hematocrit and platelets. Red blood cells count, mean corpuscular volume and neutrophils showed CVs <1.9%. Higher variability was observed for low-abundance populations such as eosinophils and basophils (up to 20%).

Conclusion: Sysmex XN-10 analyzers display a strong intra- and inter-analyzer precision for most routine hematology tests, supporting their routine usage in automated hematological lines.

References

1. Hoffmann JJML, Urrechaga E. Recent advances in laboratory hematology reflected by a decade of CCLM publications. Clin Chem Lab Med 2022;61:829-840.
2. Vis JY, Huisman A. Verification and quality control of routine hematology analyzers. Int J Lab Hematol 2016;38 Suppl 1:100-9.
3. Chhabra G. Automated hematology analyzers: Recent trends and applications. J Lab Physicians 2018;10:15-6.
4. Vidali M, Carobene A, Apassiti Esposito S, Napolitano G, Caracciolo A, et al. Standardization and harmonization in hematology: Instrument alignment, quality control materials, and commutability issue. Int J Lab Hematol 2021;43:364-71.
5. Seo JY, Lee ST, Kim SH. Performance evaluation of the new hematology analyzer Sysmex XN-series. Int J Lab Hematol 2015;37:155-64.
6. Pérez I, Redín ME, Vives A, Garrido A, Urrechaga E, Lacasta M. Local verification between the hematological analyzers Sysmex XN-series and XE-5000. Int J Lab Hematol 2016;38:256-64.
7. Birindelli S, Aloisio E, Carnevale A, Brando B, Dolci A, Panteghini M. Evaluation of long-term imprecision of automated complete blood cell count on the Sysmex XN-9000 system. Clin Chem Lab Med 2017;55:e219-22.
8. Coussee A, Robbrecht J, Maelegheer K, Vandewal W, Florin L. Evaluating the Performance of the New Sysmex XR-Series Haematology Analyser: A Comparative Study with the Sysmex XN-Series. LabMed 2025;2:5.
Published
2025/12/25
Issue
Ahead of print
Section
Short Communication

Copyright (c) 2025 Laura Pighi, Marco Tosi, Mariateresa Rizza, Gian Luca Salvagno, Giuseppe Lippi

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

The published articles will be distributed under the Creative Commons Attribution 4.0 International License (CC BY). It is allowed to copy and redistribute the material in any medium or format, and remix, transform, and build upon it for any purpose, even commercially, as long as appropriate credit is given to the original author(s), a link to the license is provided and it is indicated if changes were made. Users are required to provide full bibliographic description of the original publication (authors, article title, journal title, volume, issue, pages), as well as its DOI code. In electronic publishing, users are also required to link the content with both the original article published in Journal of Medical Biochemistry and the licence used.

Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.