Verification of the hemolysis index measurement: imprecision, accuracy, measuring range, reference interval and impact of implementing analytically and clinically derived sample rejection criteria

References

• The International Organisation for Standardisation. ISO 15189:2012: Medical laboratories – Requirements for quality and competence. 2012 [cited 2020 Feb 4]. Available from: https://www.iso.org/obp/ui/#iso:std:iso:15189:ed-3:v2:en
   Google Scholar
• Farrell JC, Carter AC. Serum indices: managing assay interference. Ann Clin Biochem. 2016;53(5):527–539.
   PubMed Web of Science ®Google Scholar
• Gabaj NN, Miler M, Vrtaric A, et al. 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. Clin Chem Lab Med. 2018;56(5):776–788.
   PubMed Web of Science ®Google Scholar
• McCaughey EJ, Vecellio E, Lake R, 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(4):143–151.
   PubMedGoogle Scholar
• Hawkins R. Discrepancy between visual and spectrophotometric assessment of sample haemolysis. Ann Clin Biochem. 2002;39(5):521–522.
   PubMedGoogle Scholar
• Simundic A-M, Nikolac N, Ivankovic V, et al. Comparison of visual vs. automated detection of lipemic, icteric and hemolyzed specimens: can we rely on a human eye? Clin Chem Lab Med. 2009;47(11):1361–1365.
   PubMed Web of Science ®Google Scholar
• Tang N, Jin X, Sun Z, et al. Effects of hemolysis and lipemia interference on kaolin-activated thromboelastography, and comparison with conventional coagulation tests. Scand J Clin Lab Invest. 2017;77(2):98–103.
   PubMed Web of Science ®Google Scholar
• Nougier C, Jousselme E, Sobas F, et al. Effects of hemolysis, bilirubin, and lipemia interference on coagulation tests detected by two analytical systems. Int J Lab Hematol. 2020;42(1):88–94.
   PubMed Web of Science ®Google Scholar
• Lippi G, Cadamuro J, von Meyer A, et al. Practical recommendations for managing hemolyzed samples in clinical chemistry testing. Clin Chem Lab Med. 2018;56(5):718–727.
   PubMed Web of Science ®Google Scholar
• Clinical and Laboratory Standards Institute (CLSI). Hemolysis, icterus and lipemia/turbidity indices as indicators of interference in clinical laboratory analysis; approved guideline. 1st ed. CLSI document C56A. Wayne (PA): Clinical and Laboratory Standards Institute; 2012.
   Google Scholar
• Gils C, Frederiksen H, Nybo M. Hemolysis-icterus-lipemia index analysis: a national survey on the validation and use on automated equipment. J App Lab Med. 2017;1(4):450–452.
   PubMedGoogle Scholar
• Cadamuro J, Lippi G, von Meyer A, et al. European survey on preanalytical sample handling – Part 2: Practices of European laboratories on monitoring and processing haemolytic, icteric and lipemic samples. Biochem Med. 2019;29:020705.
   Web of Science ®Google Scholar
• von Meyer A, Cadamuro J, Lippi G, et al. Call for more transparency in manufacturers declarations on serum indices. Clin Chim Acta . 2018;484:328–332.
   PubMed Web of Science ®Google Scholar
• Moore GL, Ledford ME, Merydith A. A micromodification of the drabkin hemoglobin assay for measuring plasma hemoglobin in the range of 5 to 2000 mg/dl. Biochem Med. 1981;26(2):167–173.
   PubMedGoogle Scholar
• Kroll MH, Elin RJ. Interference with clinical laboratory analyses. Clin Chem. 1994;40(11):1996–2005.
   PubMed Web of Science ®Google Scholar
• Monneret D, Mestari F, Atlan G, et al. Hemolysis indexes for biochemical tests and immunoassays on Roche analyzers: determination of allowable interference limits according to different calculation methods. Scand J Clin Lab Invest. 2015;75(2):162–169.
   PubMed Web of Science ®Google Scholar
• Clinical and Laboratory Standards Institute (CLSI). Reference and selected procedures for the quantitative determination of hemoglobin in blood; approved standard. 3rd ed. CLSI document H15A3. Wayne (PA): Clinical and Laboratory Standards Institute; 2000.
   Google Scholar
• Davis BH, Jungerius B, International Council for Standardization in Haematology technical report 1-2009: new reference material for haemiglobincyanide for use in standardization of blood haemoglobin measurements. Int J Lab Hematol. 2010;32(2):139–141.
   PubMed Web of Science ®Google Scholar
• Gidske G, Sølvik UØ, Sandberg S. Hemolysis interference studies – the method used in the preparation of hemolyzed samples has impact on the test results. Klinisk Biokemi i Norden. 2019;2:26–28.
   Google Scholar
• Sandberg S, Fraser CG, Horvath AR, et al. Defining analytical perfomance specifications: consensus statement from the 1st strategic conference of the European Federation of Clinical Chemistry and Laboratory Medicine. Clin Chem Lab Med. 2015;53:833–835.
   PubMed Web of Science ®Google Scholar
• EFLM Biological Variation Database. 2018–2020 [cited 2020 Feb 4]. Available from: https://biologicalvariation.eu/
   Google Scholar
• Westgard Desirable Biological Variation Database. 2019 [cited 2020 Feb 4]. Available from:https://www.westgard.com/biodatabase1.htm
   Google Scholar
• Clinical and Laboratory Standards Institue. Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline. CLSI document C28-A3c. 3rd ed. Wayne (PA): Clinical and Laboratory Standards Institue; 2008.
   Google Scholar
• Simundic AM, Bölenius K, Cadamuro J, et al. Joint EFLM-COLABIOCLI recommendation for venous blood sampling. Clin Chem Lab Med. 2018;56(12):2015–2038.
   PubMed Web of Science ®Google Scholar
• Horn PS, Pesce AJ. Reference intervals. A user’s guide. Washington (DC): AACC Press; 2005.
   Google Scholar
• Wu AHB. Hemoglobin (Hb), plasma. In: Tietz’ clinical guide to laboratory tests. 4th ed. Philadelphia (PA): Saunders; 2006. p. 522.
   Google Scholar
• Lippi G, Salvagno GL, Blanckaert N, et al. Mulitcenter evalution of the hemolysis index in automated clinical chemistry systems. Clin Chem Lab Med. 2009;47:934–939.
   PubMed Web of Science ®Google Scholar
• Aloisio E, Carnevale A, Pasqualetti S, et al. Random uncertainty of photometric determination of hemolysis index on the Abbott Architect c16000 platform. Clin Biochem. 2018;57:62–64.
   PubMed Web of Science ®Google Scholar
• 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(2):116–123.
   PubMed Web of Science ®Google Scholar
• Petrova DT, Cocisiu GA, Eberle C, 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(13–14):1298–1301.
   PubMed Web of Science ®Google Scholar
• Fernandez P, Llopis MA, Perich C, et al. Harmonization in hemolysis detection and prevention. A working group of the Catalonian Health Institute (ICS) experience. Clin Chem Lab Med. 2014;52:1557–1568.
   PubMed Web of Science ®Google Scholar
• Lippi G, Favaloro EJ, Franchini M. Haemolysis index for the screening of intravascular haemolysis: a novel diagnostic opportunity? Blood Transfus. 2018;16(5):433–437.
   PubMed Web of Science ®Google Scholar
• Lippi G, Giavarina D, Gelati M, et al. 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;429:143–146.
   PubMed Web of Science ®Google Scholar
• McEnroe R, Burritt M, Powers D. Interference testing in clinical chemistry; approved guideline. 2nd ed. Wayne (PA): Clinical and Laboratory Standards Institute; 2005.
   Google Scholar
• Koseoglu M, Hur A, Atay A, et al. Effects of hemolysis interference on routine biochemistry parameters. Biochem Med. 2011;21:79–85.
   PubMed Web of Science ®Google Scholar
• Shaskey DJ, Green GA. Sports haematology. Sports Med. 2000;29(1):27–38.
   PubMed Web of Science ®Google Scholar
• Jones GR, Newhouse I. Sport-related hematuria: a review. Clin J Sport Med. 1997;7(2):119–125.
   PubMed Web of Science ®Google Scholar
• Lippi G, Cadamuro J, von Meyer A, et al. on behalf of the European Federation of Clinical Chemistry Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE). Local quality assurance of serum or plasma (HIL) indices. Clin Biochem. 2018;54:112–118.
   PubMed Web of Science ®Google Scholar
• Lippi G, Cadamuro J, Danese E, et al. Internal quality assurance of HIL indices on Roche Cobas c702. PLoS One. 2018;13(7):e0200088.
   PubMed Web of Science ®Google Scholar
• ProBioQual. EEQ – Indices series: hemolysis/icterus/lipemia (HIL). 2011–2019 [cited 2020 Feb 4]. Available from: https://www.probioqual.com/02_EEQ/08_MULTI_DISCIPLINES/0902_EEQ_HIL.php
   Google Scholar