Jump to ContentJump to Main Navigation
Show Summary Details
More options …

Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2018: 3.638

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

Online
ISSN
1437-4331
See all formats and pricing
More options …
Volume 57, Issue 12

Issues

Multicenter performance evaluation of the Abbott Alinity hq hematology analyzer

Christiaan L. SlimORCID iD: https://orcid.org/0000-0001-9444-5075 / Brigitte A. Wevers
  • Department of Clinical Chemistry, Atalmedial Medical Diagnostic Centers, Hoofddorp, The Netherlands
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Martijn W.H.J. Demmers / Gabriella Lakos / Johannes J.M.L. HoffmannORCID iD: https://orcid.org/0000-0003-1009-4568 / Henk J. Adriaansen / Jurgen A. Kooren
  • Department of Clinical Chemistry, Atalmedial Medical Diagnostic Centers, Hoofddorp, The Netherlands
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Huibert Storm
  • Department of Clinical Chemistry, Location Medical Center Leeuwarden, Certe Medical Diagnostics & Advice, Leeuwarden, The Netherlands
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2019-07-24 | DOI: https://doi.org/10.1515/cclm-2019-0155

Abstract

Background

Alinity hq (Abbott) is a new high-throughput hematology analyzer that exclusively employs optical principles for detecting and enumerating blood cells. It reports 29 parameters, including a six-part white blood cell (WBC) differential. The aim of this multicenter study was to evaluate the analytical and clinical performance of the Alinity hq.

Methods

Complete blood count (CBC) results and morphological flagging were compared to that of CELL-DYN Sapphire (Abbott) and 2 × 200-cell manual differential results, on 1473 whole-blood samples from a well-defined patient population from three different clinical laboratories in the Netherlands. In addition, within-run and within-laboratory precision, linearity, limit of quantitation, carryover and sample stability were assessed. External quality assessment samples were also evaluated.

Results

Data analysis demonstrated strong concordance of Alinity hq results with those of CELL-DYN Sapphire for all CBC parameters, except for basophil granulocytes. Alinity hq WBC differential showed high level of agreement with manual differential results and exhibited a better agreement with manual basophil results than CELL-DYN Sapphire. The sensitivity of the Alinity hq Blast flag was 57.6%, equal to the 57.6% sensitivity of the CELL-DYN Sapphire’s Blast Alert. When considering samples with ≥5% blasts, the sensitivity of the Alinity hq Blast flag was 70.0%. Analytical performance of Alinity hq was shown to be consistent with state-of-the-art (SOTA) performance characteristics.

Conclusions

Alinity hq CBC measurands demonstrated good overall agreement with results obtained with CELL-DYN Sapphire, as well as manual WBC differential. The analytical and clinical performance characteristics of Alinity hq make it well suited for clinical laboratories.

This article offers supplementary material which is provided at the end of the article.

Keywords: evaluation; flagging; hematology analyzer; multicenter; performance

References

  • 1.

    Xiang D, Yue J, Sha C, Ren S, Li M, Wang C. Performance evaluation of the Mindray BC 6800 hematology analyzer and flag comparison with the XE-2100 and manual microscopy. Clin Lab 65. doi: . [Epub ahead of print].CrossrefWeb of SciencePubMedGoogle Scholar

  • 2.

    Bruegel M, George TI, Feng B, Allen TR, Bracco D, Zahniser DJ, et al. Multicenter evaluation of the cobas m 511 integrated hematology analyzer. Int J Lab Hematol 2018;40:672–82.CrossrefWeb of ScienceGoogle Scholar

  • 3.

    Kratz A, Lee S-H, Zini G, Riedl JA, Hur M, Machin S, et al. Digital morphology analyzers in hematology: ICSH review and recommendations. Int J Lab Hematol. doi: . [Epub ahead of print].CrossrefWeb of ScienceGoogle Scholar

  • 4.

    Aidoudi F, Baccini V, Bardet B, Lafon C, Pellicier A, Reins F, et al. Performance analysis of the « Blast » flag on ADVIA® 2120/2120i – results of a multicenter study. Ann Biol Clin (Paris) 2019;77:174–8.PubMedWeb of ScienceGoogle Scholar

  • 5.

    International Council for Standardization in Haematology, Writing Group, Briggs C, Culp N, Davis B, d’Onofrio G, Zini G, et al.ICSH guidelines for the evaluation of blood cell analysers including those used for differential leucocyte and reticulocyte counting. Int J Lab Hematol 2014;36:613–27.PubMedCrossrefWeb of ScienceGoogle Scholar

  • 6.

    H26-A2 – Validation, Verification, and Quality Assurance of Automated Hematology Analyzers. 2nd ed. Wayne, PA, USA: CLSI, 2010.Google Scholar

  • 7.

    Chow EY, Leung KK. Evaluating the CELL-DYN 3500 haematology analyser in an acute general hospital. Clin Lab Haematol 1996;18:187–93.CrossrefGoogle Scholar

  • 8.

    Müller R, Mellors I, Johannessen B, Aarsand AK, Kiefer P, Hardy J, et al. European multi-center evaluation of the Abbott Cell-Dyn sapphire hematology analyzer. Lab Hematol Off Publ Int Soc Lab Hematol 2006;12:15–31.Google Scholar

  • 9.

    Gill JE, Davis KA, Cowart WJ, Nepacena FU, Kim YR. A rapid and accurate closed-tube immunoassay for platelets on an automated hematology analyzer. Am J Clin Pathol 2000;114:47–56.CrossrefPubMedGoogle Scholar

  • 10.

    Desirable Biological Variation Database specifications – Westgard. https://www.westgard.com/biodatabase1.htm. Accessed: 5 Jun 2018.

  • 11.

    Minimum Specifications from Biological Variation database – Westgard. https://www.westgard.com/minimum-biodatabase1.htm. Accessed: 17 Dec 2018.

  • 12.

    Optimal Biological Variation database specifications – Westgard. https://www.westgard.com/optimal-biodatabase1htm.htm. Accessed: 17 Dec 2018.

  • 13.

    Biological Variation Data for setting Quality Specifications – Westgard. Available at: https://www.westgard.com/guest12.htm. Accessed: 17 Dec 2018.

  • 14.

    Vis JY, Huisman A. Verification and quality control of routine hematology analyzers. Int J Lab Hematol 2016;38(Suppl):100–9.PubMedWeb of ScienceCrossrefGoogle Scholar

  • 15.

    SKML (English). https://www.skml.nl/en/home?op=setLanguage;language=English. Accessed: 5 Jun 2018.

  • 16.

    de Jonge R, Brouwer R, de Graaf MT, Luitwieler RL, Fleming C, de Frankrijker-Merkestijn M, et al. Evaluation of the new body fluid mode on the Sysmex XE-5000 for counting leukocytes and erythrocytes in cerebrospinal fluid and other body fluids. Clin Chem Lab Med 2010;48:665–75.PubMedWeb of ScienceGoogle Scholar

  • 17.

    Armbruster DA, Pry T. Limit of blank, limit of detection and limit of quantitation. Clin Biochem Rev 2008;29:S49–S52.PubMedGoogle Scholar

  • 18.

    H20-A2 – Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods. 2nd ed. Wayne, PA, USA: CLSI, 2007.Google Scholar

  • 19.

    Barnes PW, McFadden SL, Machin SJ, Simson E, international consensus group for hematology. The international consensus group for hematology review: suggested criteria for action following automated CBC and WBC differential analysis. Lab Hematol Off Publ Int Soc Lab Hematol 2005;11:83–90.Google Scholar

  • 20.

    Schoonjans F. MedCalc’s diagnostic test evaluation calculator. MedCalc. https://www.medcalc.org/calc/diagnostic_test.php. Accessed: 1 Jun 2019.

  • 21.

    Hoffmann JJ, Yu T. Howell-Jolly body interference in reticulocyte counts. Clin Chem Lab Med 2013;51:305–6.Web of ScienceGoogle Scholar

  • 22.

    Bartlett WA, Braga F, Carobene A, Coşkun A, Prusa R, Fernandez-Calle P, et al. A checklist for critical appraisal of studies of biological variation. Clin Chem Lab Med 2015;53:879–85.Web of SciencePubMedGoogle Scholar

  • 23.

    Amundsen EK, Henriksson CE, Holthe MR, Urdal P. Is the blood basophil count sufficiently precise, accurate, and specific?: three automated hematology instruments and flow cytometry compared. Am J Clin Pathol 2012;137:86–92.Web of ScienceCrossrefPubMedGoogle Scholar

  • 24.

    Hummel K, Sachse M, Hoffmann JJ, van Dun LP. Comparative evaluation of platelet counts in two hematology analyzers and potential effects on prophylactic platelet transfusion decisions. Transfusion (Paris) 2018;58:2301–8.CrossrefGoogle Scholar

  • 25.

    Bruegel M, Nagel D, Funk M, Fuhrmann P, Zander J, Teupser D. Comparison of five automated hematology analyzers in a university hospital setting: Abbott Cell-Dyn Sapphire, Beckman Coulter DxH 800, Siemens Advia 2120i, Sysmex XE-5000, and Sysmex XN-2000. Clin Chem Lab Med 2015;53:1057–71.Web of ScienceGoogle Scholar

  • 26.

    Meintker L, Ringwald J, Rauh M, Krause SW. Comparison of automated differential blood cell counts from Abbott Sapphire, Siemens Advia 120, Beckman Coulter DxH 800, and Sysmex XE-2100 in normal and pathologic samples. Am J Clin Pathol 2013;139:641–50.CrossrefPubMedWeb of ScienceGoogle Scholar

  • 27.

    Kang SH, Kim HK, Ham CK, Lee DS, Cho HI. Comparison of four hematology analyzers, CELL-DYN Sapphire, ADVIA 120, Coulter LH 750, and Sysmex XE-2100, in terms of clinical usefulness. Int J Lab Hematol 2008;30:480–6.PubMedWeb of ScienceGoogle Scholar

  • 28.

    Hotton J, Broothaers J, Swaelens C, Cantinieaux B. Performance and abnormal cell flagging comparisons of three automated blood cell counters: Cell-Dyn Sapphire, DxH-800, and XN-2000. Am J Clin Pathol 2013;140:845–52.PubMedCrossrefGoogle Scholar

About the article

Corresponding author: Christiaan L. Slim, PhD, Department of Clinical Chemistry, Location Medical Center Leeuwarden, Certe Medical Diagnostics & Advice, Leeuwarden, The Netherlands, Phone: +31-58-288-4449

aChristiaan L. Slim and Brigitte A. Wevers contributed equally to this work.


Received: 2019-02-08

Accepted: 2019-06-17

Published Online: 2019-07-24

Published in Print: 2019-11-26


Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: Analyzers and reagents were provided free of charge by Abbott Diagnostics, Santa Clara, CA, USA.

Employment or leadership: GL is a scientific employee of Abbott Diagnostics. At the time of the study, JH was a scientific employee of Abbott Diagnostics.

Honorarium: None declared.

Competing interests: The funding organization played no role in the collection, analysis, or interpretation of data; in the writing of the report; or in the decision to submit the report for publication. The funding organization provided a minimal version of the study design that was later supplemented and finalized by the study group.


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 57, Issue 12, Pages 1988–1998, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2019-0155.

Export Citation

© 2019 Walter de Gruyter GmbH, Berlin/Boston.Get Permission

Supplementary Article Materials

Comments (0)

Please log in or register to comment.
Log in