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Development of an Integrated Reporting System for Verifying Hemolysis, Icterus, and Lipemia in Clinical Chemistry Results

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Background: Hemolysis, icterus, and lipemia (HIL) cause preanalytical interference and vary unpredictably with different analytical equipments and measurement methods. We developed an integrated reporting system for verifying HIL status in order to identify the extent of interference by HIL on clinical chemistry results. Methods: HIL interference data from 30 chemical analytes were provided by the manu- facturers and were used to generate a table of clinically relevant interference values that indicated the extent of bias at specific index values (alert index values). The HIL results generated by the Vista 1500 system (Siemens Healthcare Diagnostics, USA), Advia 2400 system (Siemens Healthcare Diagnostics), and Modular DPE system (Roche Diagnostics, Switzerland) were analyzed and displayed on physicians’ personal computers. Results: Analytes 11 and 29 among the 30 chemical analytes were affected by interfer- ence due to hemolysis, when measured using the Vista and Modular systems, respec- tively. The hemolysis alert indices for the Vista and Modular systems were 0.1-25.8% and 0.1-64.7%, respectively. The alert indices for icterus and lipemia were <1.4% and 0.7% in the Vista system and 0.7% and 1.0% in the Modular system, respectively. Conclusions: The HIL alert index values for chemical analytes varied depending on the chemistry analyzer. This integrated HIL reporting system provides an effective screening tool for verifying specimen quality with regard to HIL and simplifies the laboratory workflow.

Abstract

Background: Hemolysis, icterus, and lipemia (HIL) cause preanalytical interference and vary unpredictably with different analytical equipments and measurement methods. We developed an integrated reporting system for verifying HIL status in order to identify the extent of interference by HIL on clinical chemistry results. Methods: HIL interference data from 30 chemical analytes were provided by the manu- facturers and were used to generate a table of clinically relevant interference values that indicated the extent of bias at specific index values (alert index values). The HIL results generated by the Vista 1500 system (Siemens Healthcare Diagnostics, USA), Advia 2400 system (Siemens Healthcare Diagnostics), and Modular DPE system (Roche Diagnostics, Switzerland) were analyzed and displayed on physicians’ personal computers. Results: Analytes 11 and 29 among the 30 chemical analytes were affected by interfer- ence due to hemolysis, when measured using the Vista and Modular systems, respec- tively. The hemolysis alert indices for the Vista and Modular systems were 0.1-25.8% and 0.1-64.7%, respectively. The alert indices for icterus and lipemia were <1.4% and 0.7% in the Vista system and 0.7% and 1.0% in the Modular system, respectively. Conclusions: The HIL alert index values for chemical analytes varied depending on the chemistry analyzer. This integrated HIL reporting system provides an effective screening tool for verifying specimen quality with regard to HIL and simplifies the laboratory workflow..

참고문헌 (9)

  1. Vermeer HJ, "Automated processing of serum indices used for interference detection by the laboratory information system", Clin Chem, 51, pp.244~247 (2005)
  2. Clinical Laboratory and Standards Institute, "Hemolysis, icterus, and lipemia", turbidity indices as indicators of interference in clinical laboratory analysis. Approved guideline, C56-A, 2012
  3. ADVIA Chemistry Systems-Customer bulletin, "New serum indices normalized for ADVIA chemistry systems" (2008), Siemens Healthcare Diagnostics Inc
  4. Roche global package inserts and application reports, "Reagents on Roche", Hitachi Systems: List of interferences based on serum indices for serum and plasma. Version 12.0.Roche Diagnostics, 2010
  5. Dimension Vista® system-technical bulletin, "Sample quality assessment for hemolysis (H), icterus (I), lipemia. Siemens Healthcare Diagnostics", ~ (2009)
  6. Lippi G, "Hemolyzed specimens: a major challenge for emergency departments and clinical laboratories", Crit Rev Clin Lab Sci, 48, pp.143~153 (2011)
  7. Plebani M, "Hemolysis-resistant reagent: another part of the puzzle for preventing errors in laboratory testing", Clin Chem Lab Med, 51, pp.1339~1341 (2013)
  8. Ji JZ, "Evaluation of the interference of hemoglobin, bilirubin, and lipids on Roche Cobas 6000 assays", Clin Chim Acta, 412, pp.1550~1553 (2011)
  9. Szoke D, "Hemoglobin, bilirubin, and lipid interference on Roche Cobas 6000 assays", Clin Chim Acta, 413, pp.339~341 (2012)

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