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.
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.
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.
See AlsoAlinity h-series | High-Volume Integrated Hematology Analyzer and Testing System | Core Laboratory at AbbottAbbott Launches Alinity™ h-series Integrated Hematology System, Combining Speed, Accuracy and Seamless IntegrationAlinity m SARS-CoV-2 Assay | Abbott MolecularSigma metrics of Alinity ci system – a study on thirty-nine clinical chemistry and immunoassay parametersHonorarium: 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.
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: 10.7754/Clin.Lab.2018.180923. [Epub ahead of print].Search in Google Scholar PubMed 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;40:672–82.10.1111/ijlh.12903Search in Google Scholar PubMed 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: 10.1111/ijlh.13042. [Epub ahead of print].Search in Google Scholar PubMed 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;77:174–8.10.1684/abc.2019.1423Search in Google Scholar PubMed 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;36:613–27.10.1111/ijlh.12201Search in Google Scholar PubMed 6. H26-A2 – Validation, Verification, and Quality Assurance of Automated Hematology Analyzers. 2nd ed. Wayne, PA, USA: CLSI, 2010.Search in Google Scholar 7. Chow EY, Leung KK. Evaluating the CELL-DYN 3500 haematology analyser in an acute general hospital. Clin Lab Haematol 1996;18:187–93.10.1046/j.1365-2257.1996.00171.xSearch in Google Scholar PubMed References
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;12:15–31.10.1532/LH96.05041Search in Google Scholar PubMed
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;114:47–56.10.1309/8UJ4-P7DB-5C1J-U2H7Search in Google Scholar PubMed
10. Desirable Biological Variation Database specifications – Westgard. https://www.westgard.com/biodatabase1.htm. Accessed: 5 Jun 2018.Search in Google Scholar
11. Minimum Specifications from Biological Variation database – Westgard. https://www.westgard.com/minimum-biodatabase1.htm. Accessed: 17 Dec 2018.Search in Google Scholar
12. Optimal Biological Variation database specifications – Westgard. https://www.westgard.com/optimal-biodatabase1htm.htm. Accessed: 17 Dec 2018.Search in Google Scholar
13. Biological Variation Data for setting Quality Specifications – Westgard. Available at: https://www.westgard.com/guest12.htm. Accessed: 17 Dec 2018.Search in Google Scholar
14. Vis JY, Huisman A. Verification and quality control of routine hematology analyzers. Int J Lab Hematol 2016;38(Suppl):100–9.10.1111/ijlh.12503Search in Google Scholar PubMed
15. SKML (English). https://www.skml.nl/en/home?op=setLanguage;language=English. Accessed: 5 Jun 2018.Search in Google Scholar
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;48:665–75.10.1515/CCLM.2010.108Search in Google Scholar PubMed
17. Armbruster DA, Pry T. Limit of blank, limit of detection and limit of quantitation. Clin Biochem Rev 2008;29:S49–S52.Search in Google Scholar
18. H20-A2 – Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods. 2nd ed. Wayne, PA, USA: CLSI, 2007.Search in 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;11:83–90.10.1532/LH96.05019Search in Google Scholar PubMed
20. Schoonjans F. MedCalc’s diagnostic test evaluation calculator. MedCalc. https://www.medcalc.org/calc/diagnostic_test.php. Accessed: 1 Jun 2019.Search in Google Scholar
21. Hoffmann JJ, Yu T. Howell-Jolly body interference in reticulocyte counts. Clin Chem Lab Med 2013;51:305–6.10.1515/cclm-2013-0414Search in Google Scholar PubMed
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;53:879–85.10.1515/cclm-2014-1127Search in Google Scholar PubMed
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;137:86–92.10.1309/AJCP19BFTHYTMOROSearch in Google Scholar PubMed
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;58:2301–8.10.1111/trf.14886Search in Google Scholar PubMed
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;53:1057–71.10.1515/cclm-2014-0945Search in Google Scholar PubMed
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;139:641–50.10.1309/AJCP7D8ECZRXGWCGSearch in Google Scholar PubMed
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;30:480–6.10.1111/j.1751-553X.2007.00981.xSearch in Google 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;140:845–52.10.1309/AJCPE5R4SOQBUULZSearch in Google Scholar PubMed
Supplementary Material
The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2019-0155).
