Korean Journal of Clinical Laboratory Science (대한임상검사과학회지)

Korean Society for Clinical Laboratory Science (대한임상검사과학회)
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Investigation of an Acceptable Hemolysis Index Using Re-collected Samples

재채혈된 검체를 이용한 허용 Hemolysis Index에 대한 연구

  • Hong Bum KIM (Department of Laboratory Medicine, Kyungpook National University Hospital) ;
  • Dong Il WON (Department of Laboratory Medicine, Kyungpook National University Hospital) ;
  • Kyoung Ae SON (Department of Laboratory Medicine, Kyungpook National University Hospital) ;
  • Jin Man KIM (Department of Laboratory Medicine, Kyungpook National University Hospital) ;
  • Yu Jin WOO (Department of Laboratory Medicine, Kyungpook National University Hospital)
  • 김홍범 (경북대학교병원 진단검사의학과) ;
  • 원동일 (경북대학교병원 진단검사의학과) ;
  • 손경애 (경북대학교병원 진단검사의학과) ;
  • 김진만 (경북대학교병원 진단검사의학과) ;
  • 우유진 (경북대학교병원 진단검사의학과)
  • Received : 2023.11.27
  • Accepted : 2024.03.01
  • Published : 2024.03.31
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Abstract

This study compared the results of hemolyzed samples and re-collected samples to investigate a hemolysis influence and an acceptable hemolysis index (HI). Before and after hemolysis, alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), amylase (Amy), direct bilirubin (D-bil), total bilirubin (T-bil), creatine phosphokinase (CK), gamma glutamyl transferase (GGT), iron, potassium (K), lactate dehydrogenase (LDH), magnesium (Mg), phosphorus (Phos), total protein (TP), and uric acid (UA) showed significant results in the paired t-test. LDH, K, iron, AST, CK, GGT, TP, Amy and Phos had a high correlation between the degree of hemolysis and the results of samples. When comparing Roche's cut-off HI with HIQChigh obtained using quality control (QC) high standard deviation (SD), AST, D-bil, CK, and LDH were similar, but Amy, GGT, K, iron, Phos, and TP were lower than the cut-off HI of Roche, while ALP and ALT were higher. Some analytes which showed no significant results in the paired t-test, were found to have significant results in HI>200. Hence, it is suggested that the hemolyzed sample should be rejected if HI>200. Based on this study that some analytes were affected when HI<100, we recommend to set the standard of hemolysis starting from HI>50.

본 연구는 용혈의 영향과 허용 hemolysis index (HI)를 조사하기 위해 용혈된 검체와 재채혈된 검체의 결과를 비교하였다. 용혈 전·후, alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), amylase (Amy), direct bilirubin (D-bil), total bilirubin (T-bil), creatine phosphokinase (CK), gamma glutamyl transferase (GGT), iron, potassium (K), lactate dehydrogenase (LDH), magnesium (Mg), phosphorus (Phos), total protein (TP), uric acid (UA) 항목에서 유의미한 결과를 보였다. LDH, K, iron, AST, CK, GGT, TP, Amy, Phos는 용혈 정도와 결과 사이에 높은 상관관계가 있었다. Quality control (QC) high standard deviation (SD)을 이용하여 구한 허용 HI, HIQChigh를 비교했을 때 AST, D-bil, CK, LDH는 비슷했지만 Amy, GGT, K, iron, Phos, TP는 장비의 cut-off HI보다 낮은 HI에서부터 영향 받았으며 ALP, ALT는 높게 나왔다. 그리고 paired t-test를 통해 유의미한 결과가 없었던 albumin, cholesterol, triglyceride 항목에서도 HI>200에서는 유의미한 결과가 나왔기 때문에 재채혈하는 것이 바람직하다고 생각되며 HI<100일 때 영향을 받는 항목들이 있었던 연구 결과를 기반하여 약한 용혈이 나타나는 HI>50부터 용혈 기준을 설정하는 것을 권장한다.

Keywords

References

  1. Lippi G, Blanckaert N, Bonini P, Green S, Kitchen S, Palicka V, et al. Haemolysis: an overview of the leading cause of unsuitable specimens in clinical laboratories. Clin Chem Lab Med. 2008;46: 764-772. https://doi.org/10.1515/CCLM.2008.170 
  2. Marques-Garcia F, Jung DHH, Perez SE. Impact of individualized hemolysis management based on biological variation cut-offs in a clinical laboratory. Ann Lab Med. 2022;42:169-177. https://doi.org/10.3343/alm.2022.42.2.169 
  3. Plebani M, Sciacovelli L, Aita A, Pelloso M, Chiozza ML. Performance criteria and quality indicators for the pre-analytical phase. Clin Chem Lab Med. 2015;53:943-948. https://doi.org/10.1515/cclm-2014-1124 
  4. Simundic AM, Nikolac N, Ivankovic V, Ferenec-Ruzic D, Magdic B, Kvaternik M, 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;47:1361-1365. https://doi.org/10.1515/CCLM.2009.306 
  5. Wan Azman WN, Omar J, Koon TS, Tuan Ismail TS. Hemolyzed specimens: major challenge for identifying and rejecting specimens in clinical laboratories. Oman Med J. 2019;34:94-98. https://doi.org/10.5001/omj.2019.19 
  6. Marques-Garcia F. Methods for hemolysis interference study in laboratory medicine - a critical review. EJIFCC. 2020;31:85-97. 
  7. Simundic AM, Baird G, Cadamuro J, Costelloe SJ, Lippi G. Managing hemolyzed samples in clinical laboratories. Crit Rev Clin Lab Sci. 2020;57:1-21. https://doi.org/10.1080/10408363.2019.1664391 
  8. Jacobsz LA, Zemlin AE, Roos MJ, Erasmus RT. Chemistry and haematology sample rejection and clinical impact in a tertiary laboratory in Cape Town. Clin Chem Lab Med. 2011;49:2047-2050. https://doi.org/10.1515/CCLM.2011.743 
  9. Sung YH, Hwang MS, Lee JH, Park HD, Ryu KH, Cho MS, et al. [A comparison of the rates of hemolysis and repeated blood sampling using syringe needles versus vacuum tube needles in the emergency department]. J Korean Acad Nurs. 2012;42:443-451. Korean. https://doi.org/10.4040/jkan.2012.42.3.443 
  10. Lippi G, von Meyer A, Cadamuro J, Simundic AM. Blood sample quality. Diagnosis. 2019;6:25-31. https://doi.org/10.1515/dx2018-0018 
  11. Koseoglu M, Hur A, Atay A, Cuhadar S. Effects of hemolysis interferences on routine biochemistry parameters. Biochem Med. 2011;21:79-85. https://doi.org/10.11613/bm.2011.015 
  12. Frank JJ, Bermes EW, Bickel MJ, Watkins BF. Effect of in vitro hemolysis on chemical values for serum. Clin Chem. 1978;24:1966-1970.  https://doi.org/10.1093/clinchem/24.11.1966
  13. Lippi G, Musa R, Avanzini P, Aloe R, Pipitone S, Sandei F. Influence of in vitro hemolysis on hematological testing on Advia 2120. Int J Lab Hematol. 2012;34:179-184. https://doi.org/10.1111/j.1751-553X.2011.01378.x 
  14. Delgado JA, Morell-Garcia D, Bauca JM. Hemolysis interference studies: the particular case of sodium ion. EJIFCC. 2019;30:25-34. 
  15. Lippi G, Cadamuro J, von Meyer A, Simundic AM; European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE). Practical recommendations for managing hemolyzed samples in clinical chemistry testing. Clin Chem Lab Med. 2018;56:718-727. https://doi.org/10.1515/cclm-2017-1104 
  16. Sonntag O. Haemolysis as an interference factor in clinical chemistry. J Clin Chem Clin Biochem. 1986;24:127-139. https://doi.org/10.1515/cclm.1986.24.2.127 
  17. Greene DN, Holmes DT, Lin MJ, Liang JY, Lorey TS, Schmidt RL. Development of an equation to correct for hemolysis in direct bilirubin measurements. Clin Chim Acta. 2014;429:194-197. https://doi.org/10.1016/j.cca.2013.12.023 
  18. Farrell CJ, Carter AC. Serum indices: managing assay interference. Ann Clin Biochem. 2016;53:527-538. https://doi.org/10.1177/0004563216643557 
  19. Meites S. Letter: reproducibly simulating hemolysis, for evaluating its interference with chemical methods. Clin Chem. 1973;19:1319. 
  20. Glick MR, Ryder KW, Jackson SA. Graphical comparisons of interferences in clinical chemistry instrumentation. Clin Chem. 1986;32:470-475.  https://doi.org/10.1093/clinchem/32.3.470
  21. McEnroe RJ. Interference testing in clinical chemistry: approved guideline. 3rd ed. Clinical and Laboratory Standards Institute: 2018. p7-57. 
  22. Smith MB. Clinical and Laboratory Standards Institute. Vol. 32, Hemolysis, icterus, and lipemia/turbidity indices as indicators of interference in clinical laboratory analysis; approved guideline. CLSI: 2012. p8-37. 
  23. Pyo SS, Nam HS, Cha YJ, Lee S, Lee HK. Harmonization of hemolysis index in clinical chemistry laboratory and its application as a result verification tool. Korean J Clin Lab Sci. 2017;49:350-358. https://doi.org/10.15324/kjcls.2017.49.4.350 
  24. Won DI, Jin HK, Yoon KJ. Mathematical correction of hemolysis interference with hemolysis index. J Clin Pathol Qual Control. 2000;22:175-180. 
  25. Lippi G, Avanzini P, Pavesi F, Bardi M, Ippolito L, Aloe R, et al. Studies on in vitro hemolysis and utility of corrective formulas for reporting results on hemolyzed specimens. Biochem Med. 2011;21:297-305. https://doi.org/10.11613/bm.2011.040 
  26. Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine. Clin Chem. 2002;48:691-698. https://doi.org/10.1093/clinchem/48.5.691 
  27. Lippi G, Blanckaert N, Bonini P, Green S, Kitchen S, Palicka V, et al. Causes, consequences, detection, and prevention of identification errors in laboratory diagnostics. Clin Chem Lab Med. 2009;47:143-153. https://doi.org/10.1515/CCLM.2009.045