본문 바로가기
KERD
논문KCI 등재

Effect of Outlier Elimination on the 99th Percentile Upper Reference Limits of High-Sensitivity Cardiac Troponin I Assays Based on a Strictly Selected Healthy Reference Population

2

조회

0

다운로드

0

인용

0

참고문헌

키워드

주제분류병리학

초록

Background: We established high-sensitivity cardiac troponin I (hsTnI) 99th percentile upper reference limits (URLs) for the Centaur XPT High-Sensitivity Troponin I assay (Centaur hsTnI; Siemens, Erlangen, Germany) and Atellica IM High-Sensitivity Troponin I assay (Atellica hsTnI; Siemens) and assessed the effect of outlier elimination. Methods: The reference population comprised 380 men and 387 women, satisfying the strict systematic reference population criteria. After reference population verification by the N-terminal pro-B-type natriuretic peptide (NT-proBNP) assay, 99th percentile URLs for Centaur hsTnI and Atellica hsTnI were calculated before and after outlier elimination. Results: The 99th percentile URL for Centaur hsTnI was 60.4 (men, 74.7; women, 57.5) ng/L and that for Atellica hsTnI was 59.6 (men, 75.2; women, 55.1) ng/L. After the elimination of 61 (8.0%) outlier samples in Centaur hsTnI and 58 (7.6%) in Atellica hsTnI, the 99th percentile URLs were 13.5 ng/L (men, 15.3 ng/L; women, 11.9 ng/L) and 13.4 ng/L (men, 15.5 ng/L; women, 12.9 ng/L), respectively, significantly lower than those before outlier elimination. The CVs at the 99th percentile URLs were 5.2% and 3.5%, respectively. The measurable fractions among the reference population were 91.5% and 93.4%, respectively. Performance evaluation of Atellica B-type natriuretic peptide (BNP), Atellica NT-proBNP, Centaur hsTnI, and Atellica hsTnI showed outstanding results. Conclusions: The Korean hsTnI 99th percentile URLs calculated in this study were significantly lower after outlier elimination than before. Centaur hsTnI and Atellica hsTnI meet the “Guideline acceptable” and “Level 3 (second generation, high sensitivity)” requirements, satisfying international standards.

Abstract

Background: We established high-sensitivity cardiac troponin I (hsTnI) 99th percentile upper reference limits (URLs) for the Centaur XPT High-Sensitivity Troponin I assay (Centaur hsTnI; Siemens, Erlangen, Germany) and Atellica IM High-Sensitivity Troponin I assay (Atellica hsTnI; Siemens) and assessed the effect of outlier elimination. Methods: The reference population comprised 380 men and 387 women, satisfying the strict systematic reference population criteria. After reference population verification by the N-terminal pro-B-type natriuretic peptide (NT-proBNP) assay, 99th percentile URLs for Centaur hsTnI and Atellica hsTnI were calculated before and after outlier elimination. Results: The 99th percentile URL for Centaur hsTnI was 60.4 (men, 74.7; women, 57.5) ng/L and that for Atellica hsTnI was 59.6 (men, 75.2; women, 55.1) ng/L. After the elimination of 61 (8.0%) outlier samples in Centaur hsTnI and 58 (7.6%) in Atellica hsTnI, the 99th percentile URLs were 13.5 ng/L (men, 15.3 ng/L; women, 11.9 ng/L) and 13.4 ng/L (men, 15.5 ng/L; women, 12.9 ng/L), respectively, significantly lower than those before outlier elimination. The CVs at the 99th percentile URLs were 5.2% and 3.5%, respectively. The measurable fractions among the reference population were 91.5% and 93.4%, respectively. Performance evaluation of Atellica B-type natriuretic peptide (BNP), Atellica NT-proBNP, Centaur hsTnI, and Atellica hsTnI showed outstanding results. Conclusions: The Korean hsTnI 99th percentile URLs calculated in this study were significantly lower after outlier elimination than before. Centaur hsTnI and Atellica hsTnI meet the “Guideline acceptable” and “Level 3 (second generation, high sensitivity)” requirements, satisfying international standards.

참고문헌 (32)

  1. Bodor GS, "Cardiac troponin-I is not expressed in fetal and healthy or diseased adult human skeletal muscle tissue", Clin Chem, 41, pp.1710~1715 (1995)
  2. Thygesen K, "Fourth universal definition of myocardial infarction(2018)", Circulation, 138, pp.e618~e651 (2018)
  3. Reichlin T, "Early diagnosis of myocardial infarction with sensitive cardiac troponin assays", N Engl J Med, 361, pp.858~867 (2009)
  4. Mahajan VS, "How to interpret elevated cardiac troponin levels", Circulation, 124, pp.2350~2354 (2011)
  5. Collinson PO, "Influence of population selection on the 99th percentile reference value for cardiac troponin assays", Clin Chem, 58, pp.219~225 (2012)
  6. Ko DH, "The 99th percentile values of six cardiac troponin assays established for a reference population using strict selection criteria", Clin Chim Acta, 464, pp.1~5 (2017)
  7. Di Pietro M, "Assessment of Access hsTnI 99th percentiles upper reference limits following IFCC recommendations", Clin Chim Acta, 492, pp.26~28 (2019)
  8. Clerico A, "The 99th percentile of reference population for cTnI and cTnT assay: methodology, pathophysiology and clinical implications", Clin Chem Lab Med, 55, pp.1634~1651 (2017)
  9. Clerico A, "Head-to-head comparison of plasma cTnI concentration values measured with three high-sensitivity methods in a large Italian population of healthy volunteers and patients admitted to emergency department with acute coronary syndrome : A multi-center study", Clin Chim Acta, 496, pp.25~34 (2019)
  10. Sandoval Y, "The global need to define normality : the 99th percentile value of cardiac troponin", Clin Chem, 60, pp.455~462 (2014)
  11. Wu AHB, "Clinical Laboratory practice recommendations for the use of cardiac troponin in acute coronary syndrome : expert opinion from the Academy of the American Association for Clinical Chemistry and the Task Force on Clinical Applications of Cardiac Bio-markers of the International Federation of Clinical Chemistry and Laboratory Medicine", Clin Chem, 64, pp.645~655 (2018)
  12. Hickman PE, "Statistical considerations for determining high-sensitivity cardiac troponin reference intervals", Clin Biochem, 50, pp.502~505 (2017)
  13. Eggers KM, "The applied statistical approach highly influences the 99th percentile of cardiac troponin I", Clin Biochem, 49, pp.1109~1112 (2016)
  14. Clerico A, "Evidence on clinical relevance of cardiovascular risk evaluation in the general population using cardio-specific biomarkers", Clin Chem Lab Med, 59, pp.79~90 (2020)
  15. Farmakis D, "High-sensitivity cardiac troponin assays for cardiovascular risk stratification in the general population", Eur Heart J, 41, pp.4050~4056 (2020)
  16. CLSI, "Evaluation of precision performance of quantitative measurement methods: approved guideline" (2004), Clinical and Laboratory Standards Institute
  17. CLSI, "Evaluation of the linearity of quantitative measurement procedures: A statistical approach: approved guideline" (2003), Clinical and Laboratory Standards Institute
  18. "Desirable Biological Variation Database specifications: Desirable specifications for total error, imprecision, and bias, derived from intra- and inter-individual biologic variation" (2014)[URL]
  19. CLSI, "Method comparison and bias estimation using patient samples: approved guidelines" (2002), Clinical and Laboratory Standards Institute
  20. Franzini M, "The calculation of the cardiac troponin T 99th percentile of the reference population is affected by age, gender, and population selection: a multicenter study in Italy", Clin Chim Acta, 438, pp.376~381 (2015)
  21. Hickman PE, "Cardiac troponin may be released by ischemia alone, without necrosis", Clin Chim Acta, 411, pp.318~323 (2010)
  22. "Exploratory data analysis, 1977"[URL]
  23. Clerico A, "Evaluation of 99th percentile and reference change values of the hs-cTnI method using ADVIA Centaur XPT platform : A multicenter study", Clin Chim Acta, 495, pp.161~166 (2019)
  24. Ji M, "Determination of high-sensitivity cardiac troponin I 99th percentile upper reference limits in a healthy Korean population", Clin Biochem, 49, pp.756~761 (2016)
  25. Moon SY, "99th percentile upper reference limit of AccuTnI+3 in a Korean reference population : a multicenter study using fresh serum", Clin Chem Lab Med, 57, pp.e282~e284 (2019)
  26. Kim S, "Evaluation of the new Beckman Coulter Access hsTnI : 99th percentile upper reference limits according to age and sex in the Korean population", Clin Biochem, 79, pp.48~53 (2020)
  27. Apple FS, "Sex-Specific 99th percentile upper reference limits for high sensitivity cardiac troponin assays derived using a universal sample bank", Clin Chem, 66, pp.434~444 (2020)
  28. Musetti V, "Evaluation of the analytical performance of a new ADVIA immunoassay using the Centaur XPT platform system for the measurement of cardiac troponin I", Clin Chem Lab Med, 56, pp.e229~e231 (2018)
  29. Petersmann A, "Comparison of the 99th percentiles of three troponin I assays in a large reference population", Clin Chem Lab Med, 51, pp.2181~2186 (2013)
  30. Apple FS, "A new season for cardiac troponin assays : it’s time to keep a scorecard", Clin Chem, 55, pp.1303~1306 (2009)
  31. Jong Won Kim, "Absolute Change in High-Sensitivity Cardiac Troponin I at Three Hours After Presentation is Useful for Diagnosing Acute Myocardial Infarction in the Emergency Department", Annals of Laboratory Medicine, 40(6), pp.474~480 (2020), 대한진단검사의학회[DOI]
  32. Li Tingting, "Moving Rate of Positive Patient Results as a Quality Control Tool for High-Sensitivity Cardiac Troponin T Assays", Annals of Laboratory Medicine, 41(1), pp.51~59 (2021), 대한진단검사의학회[DOI]

관련 논문AI추천

이 간행물의 다른 논문 (15건)