Startseite Multicenter performance evaluation of the Abbott Alinity hq hematology analyzer
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Multicenter performance evaluation of the Abbott Alinity hq hematology analyzer

  • Christiaan L. Slim ORCID logo EMAIL logo , Brigitte A. Wevers , Martijn W.H.J. Demmers , Gabriella Lakos , Johannes J.M.L. Hoffmann ORCID logo , Henk J. Adriaansen , Jurgen A. Kooren und Huibert Storm
Veröffentlicht/Copyright: 24. Juli 2019
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Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 57 Heft 12

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.

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

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. The re-emergence of dried blood spot sampling – are we ready?
  4. Review
  5. The role of platelets in bleeding in patients with thrombocytopenia and hematological disease
  6. Opinion Paper
  7. Exertional hematuria: definition, epidemiology, diagnostic and clinical considerations
  8. Guidelines and Recommendations from Scientific Societies
  9. A protocol for testing the stability of biochemical analytes. Technical document
  10. Genetics and Molecular Diagnostics
  11. Hereditary hyperferritinaemia-cataract syndrome (HHCS) – an underestimated condition: ferritin light chain variant spectrum in German families
  12. General Clinical Chemistry and Laboratory Medicine
  13. Performance of a web-based application measuring spot quality in dried blood spot sampling
  14. Clinical application of a dried blood spot assay for sirolimus and everolimus in transplant patients
  15. Plasma and dried blood spot lysosphingolipids for the diagnosis of different sphingolipidoses: a comparative study
  16. Liquid biopsy of cerebrospinal fluid identifies neuronal pentraxin receptor (NPTXR) as a biomarker of progression of Alzheimer’s disease
  17. Integrity of serum samples is changed by modified centrifugation conditions
  18. Heparin and citrate additive carryover during blood collection
  19. Copeptin – a biomarker of short-term mortality risk (7 days) in patients with end-stage liver disease
  20. Comparison of a new rapid method for the determination of adalimumab serum levels with two established ELISA kits
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  22. Establishment of the intelligent verification criteria for a routine urinalysis analyzer in a multi-center study
  23. Reference Values and Biological Variations
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  26. Early pregnancy reference intervals; 29 serum analytes from 4 to 12 weeks’ gestation in naturally conceived and uncomplicated pregnancies resulting in live births
  27. Paediatric reference intervals for 17 Roche cobas 8000 e602 immunoassays in the CALIPER cohort of healthy children and adolescents
  28. Hematology and Coagulation
  29. Study of the analytical performance at different concentrations of hematological parameters using Spanish EQAS data
  30. Multicenter performance evaluation of the Abbott Alinity hq hematology analyzer
  31. Cardiovascular Diseases
  32. Fast 0/1-h algorithm for detection of NSTEMI: are current high-sensitivity cardiac troponin assays fit for purpose? An EQA-based evaluation
  33. Infectious Diseases
  34. Diagnostic performance of cerebrospinal fluid free light chains in Lyme neuroborreliosis – a pilot study
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  36. Quality management at the national biobanking level – establishing a culture of mutual trust and support: the BBMRI.at example
  37. Molecular diagnosis of MODY3 permitted to reveal a de novo 12q24.31 deletion and to explain a complex phenotype in a young diabetic patient
  38. Increased C-reactive protein values in the absence of inflammation: monoclonal immunoglobulin interference in immunonephelometry
  39. An approach based on simulated hemolysis for establishing the hemolysis index threshold for high-sensitivity cardiac troponin T assay
  40. Utility of the icteric index for the management of bilirubin test requesting
  41. Quality control of monocyte volume and distribution width parameters of the Beckman Coulter DxH series
  42. Mozhaisk haemoglobin variant effects on leukocyte differential channel using the Sysmex XN series
  43. Detection of a novel hemoglobin variant Hb Liaoning by matrix assisted laser desorption/ionization-time of flight mass spectrometry
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  45. Congress Abstracts
  46. 51th National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC – Laboratory Medicine)
https://doi.org/10.1515/cclm-2019-0155
Schlagwörter für diesen Artikel
evaluation; flagging; hematology analyzer; multicenter; performance

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. The re-emergence of dried blood spot sampling – are we ready?
  4. Review
  5. The role of platelets in bleeding in patients with thrombocytopenia and hematological disease
  6. Opinion Paper
  7. Exertional hematuria: definition, epidemiology, diagnostic and clinical considerations
  8. Guidelines and Recommendations from Scientific Societies
  9. A protocol for testing the stability of biochemical analytes. Technical document
  10. Genetics and Molecular Diagnostics
  11. Hereditary hyperferritinaemia-cataract syndrome (HHCS) – an underestimated condition: ferritin light chain variant spectrum in German families
  12. General Clinical Chemistry and Laboratory Medicine
  13. Performance of a web-based application measuring spot quality in dried blood spot sampling
  14. Clinical application of a dried blood spot assay for sirolimus and everolimus in transplant patients
  15. Plasma and dried blood spot lysosphingolipids for the diagnosis of different sphingolipidoses: a comparative study
  16. Liquid biopsy of cerebrospinal fluid identifies neuronal pentraxin receptor (NPTXR) as a biomarker of progression of Alzheimer’s disease
  17. Integrity of serum samples is changed by modified centrifugation conditions
  18. Heparin and citrate additive carryover during blood collection
  19. Copeptin – a biomarker of short-term mortality risk (7 days) in patients with end-stage liver disease
  20. Comparison of a new rapid method for the determination of adalimumab serum levels with two established ELISA kits
  21. Measurement of α-dicarbonyl compounds in human saliva by pre-column derivatization HPLC
  22. Establishment of the intelligent verification criteria for a routine urinalysis analyzer in a multi-center study
  23. Reference Values and Biological Variations
  24. A new indirect estimation of reference intervals: truncated minimum chi-square (TMC) approach
  25. EGFR and EGFR ligands in serum in healthy women; reference intervals and age dependency
  26. Early pregnancy reference intervals; 29 serum analytes from 4 to 12 weeks’ gestation in naturally conceived and uncomplicated pregnancies resulting in live births
  27. Paediatric reference intervals for 17 Roche cobas 8000 e602 immunoassays in the CALIPER cohort of healthy children and adolescents
  28. Hematology and Coagulation
  29. Study of the analytical performance at different concentrations of hematological parameters using Spanish EQAS data
  30. Multicenter performance evaluation of the Abbott Alinity hq hematology analyzer
  31. Cardiovascular Diseases
  32. Fast 0/1-h algorithm for detection of NSTEMI: are current high-sensitivity cardiac troponin assays fit for purpose? An EQA-based evaluation
  33. Infectious Diseases
  34. Diagnostic performance of cerebrospinal fluid free light chains in Lyme neuroborreliosis – a pilot study
  35. Letters to the Editor
  36. Quality management at the national biobanking level – establishing a culture of mutual trust and support: the BBMRI.at example
  37. Molecular diagnosis of MODY3 permitted to reveal a de novo 12q24.31 deletion and to explain a complex phenotype in a young diabetic patient
  38. Increased C-reactive protein values in the absence of inflammation: monoclonal immunoglobulin interference in immunonephelometry
  39. An approach based on simulated hemolysis for establishing the hemolysis index threshold for high-sensitivity cardiac troponin T assay
  40. Utility of the icteric index for the management of bilirubin test requesting
  41. Quality control of monocyte volume and distribution width parameters of the Beckman Coulter DxH series
  42. Mozhaisk haemoglobin variant effects on leukocyte differential channel using the Sysmex XN series
  43. Detection of a novel hemoglobin variant Hb Liaoning by matrix assisted laser desorption/ionization-time of flight mass spectrometry
  44. Appropriateness of repetitive therapeutic drug monitoring and laboratory turnaround time
  45. Congress Abstracts
  46. 51th National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC – Laboratory Medicine)
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