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Licensed Unlicensed Requires Authentication Published by De Gruyter July 24, 2019

Multicenter performance evaluation of the Abbott Alinity hq hematology analyzer

Christiaan L. Slim ORCID logo, Brigitte A. Wevers, Martijn W.H.J. Demmers, Gabriella Lakos, Johannes J.M.L. Hoffmann ORCID logo, Henk J. Adriaansen, Jurgen A. Kooren and Huibert Storm

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.


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.

Acknowledgments

We thank Gerard Poiesz, Jisk Koopmans and Gea de Jong (Certe), Carin de Swart-Scholtes, Marion Taskin and technicians (Atalmedial), Dinanda Wes and Sabine Damhuis (Gelre) for their help with analyzing the samples.

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

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

  3. 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.

  4. Honorarium: None declared.

  5. 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.

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2019-0155).


Received: 2019-02-08
Accepted: 2019-06-17
Published Online: 2019-07-24
Published in Print: 2019-11-26

© 2019 Walter de Gruyter GmbH, Berlin/Boston

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