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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

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1437-4331
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Volume 56, Issue 5

Issues

Precision, accuracy, cross reactivity and comparability of serum indices measurement on Abbott Architect c8000, Beckman Coulter AU5800 and Roche Cobas 6000 c501 clinical chemistry analyzers

Nora Nikolac Gabaj
  • Corresponding author
  • Working Group for Preanalytical Phase of the Croatian Society of Medical Biochemistry and Laboratory Medicine, Zagreb, Croatia
  • Department of Clinical Chemistry, Sestre Milosrdnice University Hospital Center, Zagreb, Croatia
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Marijana Miler
  • Working Group for Preanalytical Phase of the Croatian Society of Medical Biochemistry and Laboratory Medicine, Zagreb, Croatia
  • Department of Clinical Chemistry, Sestre Milosrdnice University Hospital Center, Zagreb, Croatia
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Alen Vrtarić
  • Working Group for Preanalytical Phase of the Croatian Society of Medical Biochemistry and Laboratory Medicine, Zagreb, Croatia
  • Department of Clinical Chemistry, Sestre Milosrdnice University Hospital Center, Zagreb, Croatia
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Marina Hemar
  • Working Group for Preanalytical Phase of the Croatian Society of Medical Biochemistry and Laboratory Medicine, Zagreb, Croatia
  • Medical biochemistry laboratory, Polyclinic Salzer, Zagreb, Croatia
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Petra Filipi
  • Working Group for Preanalytical Phase of the Croatian Society of Medical Biochemistry and Laboratory Medicine, Zagreb, Croatia
  • Department of Medical Laboratory Diagnostics, University Hospital Centre Split, Split, Croatia
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  • De Gruyter OnlineGoogle Scholar
/ Marija Kocijančić
  • Working Group for Preanalytical Phase of the Croatian Society of Medical Biochemistry and Laboratory Medicine, Zagreb, Croatia
  • Department of Laboratory Diagnostics, Primary Health Care of Primorsko-goranska County, Rijeka, Croatia
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Vesna Šupak Smolčić
  • Working Group for Preanalytical Phase of the Croatian Society of Medical Biochemistry and Laboratory Medicine, Zagreb, Croatia
  • Clinical Department of Laboratory Diagnostics, Clinical Hospital Center Rijeka, Rijeka, Croatia
  • Department of Medical Informatics, Rijeka University School of Medicine, Rijeka, Croatia
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Ivana Ćelap
  • Working Group for Preanalytical Phase of the Croatian Society of Medical Biochemistry and Laboratory Medicine, Zagreb, Croatia
  • Department of Clinical Chemistry, Sestre Milosrdnice University Hospital Center, Zagreb, Croatia
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Ana-Maria Šimundić
  • Working Group for Preanalytical Phase of the Croatian Society of Medical Biochemistry and Laboratory Medicine, Zagreb, Croatia
  • Department of Medical Laboratory Diagnostics, University Hospital “Sveti Duh”, Zagreb, Croatia
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2018-01-09 | DOI: https://doi.org/10.1515/cclm-2017-0889

Abstract

Background:

The aim of our study was to perform verification of serum indices on three clinical chemistry platforms.

Methods:

This study was done on three analyzers: Abbott Architect c8000, Beckman Coulter AU5800 (BC) and Roche Cobas 6000 c501. The following analytical specifications were verified: precision (two patient samples), accuracy (sample with the highest concentration of interferent was serially diluted and measured values compared to theoretical values), comparability (120 patients samples) and cross reactivity (samples with increasing concentrations of interferent were divided in two aliquots and remaining interferents were added in each aliquot. Measurements were done before and after adding interferents).

Results:

Best results for precision were obtained for the H index (0.72%–2.08%). Accuracy for the H index was acceptable for Cobas and BC, while on Architect, deviations in the high concentration range were observed (y=0.02 [0.01–0.07]+1.07 [1.06–1.08]x). All three analyzers showed acceptable results in evaluating accuracy of L index and unacceptable results for I index. The H index was comparable between BC and both, Architect (Cohen’s κ [95% CI]=0.795 [0.692–0.898]) and Roche (Cohen’s κ [95% CI]=0.825 [0.729–0.922]), while Roche and Architect were not comparable. The I index was not comparable between all analyzer combinations, while the L index was only comparable between Abbott and BC. Cross reactivity analysis mostly showed that serum indices measurement is affected when a combination of interferences is present.

Conclusions:

There is heterogeneity between analyzers in the hemolysis, icteria, lipemia (HIL) quality performance. Verification of serum indices in routine work is necessary to establish analytical specifications.

Keywords: analytical verification; hemolysis; icteria; interference; lipemia; preanalytical phase; serum indices

References

  • 1.

    McCaughey EJ, Vecellio E, Lake R, Li L, Burnett L, Chesher D, et al. Current methods of haemolysis detection and reporting as a source of risk to patient safety: a narrative review. Clin Biochem Rev 2016;37:143–51.PubMedGoogle Scholar

  • 2.

    Simundic AM, Nikolac N, Ivankovic V, Ferenec-Ruzic D, Magdic B, Kvaternik M, et al. Comparison of visual versus automated detection of lipemic, icteric and hemolyzed specimens: can we rely on a human eye? Clin Chem Lab Med 2009;47:1361–5.Google Scholar

  • 3.

    Lippi G. Systematic assessment of the hemolysis index: pros and cons. Adv Clin Chem 2015;71:157–70.PubMedCrossrefGoogle Scholar

  • 4.

    Farrell CJ, Carter AC. Serum indices: managing assay interference. Ann Clin Biochem 2016;53(Pt 5):527–38.CrossrefPubMedGoogle Scholar

  • 5.

    Lippi G, Plebani M. Continuous-flow automation and hemolysis index: a crucial combination. J Lab Autom 2013;18:184–8.CrossrefPubMedGoogle Scholar

  • 6.

    Lippi G, Avanzini P, Campioli D, Da Rin G, Dipalo M, Aloe R, et al. Systematical assessment of serum indices does not impair efficiency of clinical chemistry testing: a multicenter study. Clin Biochem 2013;46:1281–4.PubMedCrossrefGoogle Scholar

  • 7.

    Clinical and Laboratory Standards Institute (CLSI). Hemolysis, icterus, and lipemia/turbidity indices as indicators of interference in clinical laboratory analysis; approved guideline. CLSI document C56-A. Wayne, PE, USA: Clinical and Laboratory Standards Institute, 2012.Google Scholar

  • 8.

    Dolci A, Panteghini M. Harmonization of automated hemolysis index assessment and use: is it possible? Clin Chim Acta 2014;432:38–43.CrossrefPubMedGoogle Scholar

  • 9.

    Topic E, Nikolac N, Panteghini M, Theodorsson E, Salvagno GL, Miler M, et al. How to assess the quality of your analytical method? Clin Chem Lab Med 2015;53:1707–18.PubMedGoogle Scholar

  • 10.

    Boyd JM, Krause R, Waite G, Hui W, Yazdi E, Wilmink D, et al. Developing optimized automated rule sets for reporting hemolysis, icterus and lipemia based on a priori outcomes analysis. Clin Chim Acta 2015;450:31–8.PubMedCrossrefGoogle Scholar

  • 11.

    Shin DH, Kim J, Uh Y, Lee SI, Seo DM, Kim KS, et al. Development of an integrated reporting system for verifying hemolysis, icterus, and lipemia in clinical chemistry results. Ann Lab Med 2014;34:307–12.CrossrefPubMedGoogle Scholar

  • 12.

    Clinical and Laboratory Standards Institute. Evaluation of Precision Performance of Quantitative measurement Methods; Approved Guideline, Second edition; EP5-A2. Wayne, PA, USA: Clinical and Laboratory Standards Institute, 2004.Google Scholar

  • 13.

    McHugh ML. Interrater reliability: the kappa statistic. Biochem Med (Zagreb) 2012;22:276–82.PubMedGoogle Scholar

  • 14.

    Nikolac N, Celap I, Filipi P, Hemar M, Kocijancic M, Miler M, et al. Croatian laboratories have a good knowledge of the proper detection and management of hemolyzed, icteric and lipemic samples. Clin Chem Lab Med 2016;54:419–25.PubMedGoogle Scholar

  • 15.

    Dorotić A, Antončić D, Biljak VR, Nedić D, Beletić A. Hemolysis from a nurses’ standpoint – survey from four Croatian hospitals. Biochem Med (Zagreb) 2015;25:393–400.PubMedGoogle Scholar

  • 16.

    Lippi G, Luca Salvagno G, Blanckaert N, Giavarina D, Green S, Kitchen S, et al. Multicenter evaluation of the hemolysis index in automated clinical chemistry systems. Clin Chem Lab Med 2009;47:934–9.PubMedGoogle Scholar

  • 17.

    Lippi G. Interference studies: focus on blood cell lysates preparation and testing. Clin Lab 2012;58:351–5.PubMedGoogle Scholar

  • 18.

    Clinical and Laboratory Standards Institute (CLSI). Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard, Third Edition. CLSI document H15A3. Wayne, PE, USA: Clinical and Laboratory Standards Institute, 2000.Google Scholar

  • 19.

    Han V, Serrano K, Devine DV. A comparative study of common techniques used to measure haemolysis in stored red cell concentrates. Vox Sang 2010;98:116–23.PubMedCrossrefGoogle Scholar

  • 20.

    Fernandez P, Llopis MA, Perich C, Alsina MJ, Alvarez V, Biosca C, et al. Harmonization in hemolysis detection and prevention. A working group of the Catalonian Health Institute (ICS) experience. Clin Chem Lab Med 2014;52:1557–68.Google Scholar

  • 21.

    Kroll MH, McCudden CR. Endogenous interferences in clinical laboratory tests. Icteric, lipemic and turbid samples. Berlin/Boston: Walter de Gruyter GmbH, 2013.Google Scholar

  • 22.

    Alvarez F, Whalen K, Scott MG. Conjugated, but not unconjugated, bilirubin negatively interferes in Hitachi 747 assay of inorganic phosphorus. Clin Chem USA 1993;39:2345–6.Google Scholar

  • 23.

    Nikolac Gabaj N, Miler M, Mihic R. I index is not an accurate indicator of icteria in conjugated hyperbilirubinemia. Clin Chim Acta 2017;473:32–4.CrossrefPubMedGoogle Scholar

  • 24.

    Salinas M, López-Garrigós M, Lugo J, Gutiérrez M, Flors L, Leiva-Salinas C. Diagnostic accuracy of icteric index to detect abnormal total bilirubin values. J Clin Pathol 2012;65: 928–33.CrossrefPubMedGoogle Scholar

  • 25.

    Nicolay A, Lorec AM, Gomez G, Portugal H. Icteric human samples: icterus index and method of estimating an interference-free value for 16 biochemical analyses. J Clin Lab Anal 2017. doi: 10.1002/jcla.22229. [Epub ahead of print].PubMedGoogle Scholar

  • 26.

    Nikolac N, Simundic AM, Miksa M, Lima-Oliveira G, Salvagno GL, Caruso B, et al. Heterogeneity of manufacturers’ declarations for lipemia interference – urgent call for standardization. Clin Chim Acta 2013;426:33–40.CrossrefPubMedGoogle Scholar

  • 27.

    Grunbaum AM, Gilfix BM, Hoffman RS, Lavergne V, Morris M, Miller-Nesbitt A, et al. Review of the effect of intravenous lipid emulsion on laboratory analyses. Clin Toxicol (Phila) 2016;54:92–102.PubMedCrossrefGoogle Scholar

  • 28.

    Nikolac N. Lipemia: causes, interference mechanisms, detection and management. Biochem Med (Zagreb) 2014;24:57–67.PubMedGoogle Scholar

  • 29.

    Twomey PJ, Don-Wauchope AC, McCullough D. Unreliability of triglyceride measurement to predict turbidity induced interference. J Clin Pathol 2003;56:861–2.PubMedCrossrefGoogle Scholar

  • 30.

    Lippi G, Giavarina D, Gelati M, Salvagno GL. Reference range of hemolysis index in serum and lithium-heparin plasma measured with two analytical platforms in a population of unselected outpatients. Clin Chim Acta 2014;429:143–6.CrossrefGoogle Scholar

  • 31.

    Petrova DT, Cocisiu GA, Eberle C, Rhode KH, Brandhorst G, Walson PD, et al. Can the Roche hemolysis index be used for automated determination of cell-free hemoglobin? A comparison to photometric assays. Clin Biochem 2013;46:1298–301.PubMedCrossrefGoogle Scholar

About the article

Received: 2017-10-03

Accepted: 2017-11-13

Published Online: 2018-01-09

Published in Print: 2018-04-25


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

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 56, Issue 5, Pages 776–788, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2017-0889.

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