Determination of high-sensitivity cardiac troponin I 99th percentile upper reference limits in a healthy Korean population

Clinical Biochemistry

Volumn 49, Issue 10-11, 2016, Pages 756-761

  Ji, Misuk ^a   Moon, Hee Won ^a   Hur, Mina ^a   Yun, Yeo Min ^a  

^a Konkuk University School of Medicine   (South Korea)

Author keywords

99th percentile; High sensitivity; Reference population; Troponin I

Indexed keywords

TROPONIN I; BIOLOGICAL MARKER; TROPONIN T;

ADULT; AGE; ARTICLE; CARDIAC TROPONIN 1 CLIA; CARDIAC TROPONIN 1 CLIA KIT; FEMALE; HUMAN; IMMUNOASSAY ANALYZER; KOREAN (PEOPLE); MALE; MIDDLE AGED; NORMAL HUMAN; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; REFERENCE VALUE; SEX DIFFERENCE; ADOLESCENT; AGED; BLOOD; CARDIOVASCULAR DISEASES; FOLLOW UP; IMMUNOASSAY; LABORATORY; POINT OF CARE SYSTEM; PROCEDURES; PROGNOSIS; RECEIVER OPERATING CHARACTERISTIC; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; BIOMARKERS; CARDIOVASCULAR DISEASES; FEMALE; FOLLOW-UP STUDIES; HUMANS; IMMUNOASSAY; LABORATORIES; MALE; MIDDLE AGED; POINT-OF-CARE SYSTEMS; PROGNOSIS; REFERENCE VALUES; ROC CURVE; TROPONIN I; TROPONIN T; YOUNG ADULT;

EID: 84963582760     PISSN: 00099120     EISSN: 18732933     Source Type: Journal    
DOI: 10.1016/j.clinbiochem.2016.01.027     Document Type: Article

References (33)

1. [1] Thygesen, K., Alpert, J.S., Jaffe, A.S., et al. Third universal definition of myocardial infarction. Eur. Heart J. 33 (2012), 2551–2567.
2. [2] Apple, F.S., Ler, R., Murakami, M.M., Determination of 19 cardiac troponin I and T assay 99th percentile values from a common presumably healthy population. Clin. Chem. 58 (2012), 1574–1581.
3. [3] Apple, F.S., Standardization of cardiac troponin I assays will not occur in my lifetime. Clin. Chem. 58 (2012), 169–171.
4. [4] Sandoval, Y., Apple, F.S., The global need to define normality: the 99th percentile value of cardiac troponin. Clin. Chem. 60 (2014), 455–462.
5. [5] Zeller, T., Ojeda, F., Brunner, F.J., et al. High-sensitivity cardiac troponin I in the general population - defining reference populations for the determination of the 99th percentile in the Gutenberg Health Study. Clin. Chem. Lab. Med. 53 (2015), 699–706.
6. [6] Apple, F.S., Collinson, P.O., Analytical characteristics of high-sensitivity cardiac troponin assays. Clin. Chem. 58 (2012), 54–61.
7. [7] Koerbin, G., Abhayaratna, W.P., Potter, J.M., et al. Effect of population selection on 99th percentile values for a high sensitivity cardiac troponin I and T assays. Clin. Biochem. 46 (2013), 1636–1643.
8. [8] Krintus, M., Kozinski, M., Boudry, P., et al. Defining normality in a European multinational cohort: critical factors influencing the 99th percentile upper reference limit for high sensitivity cardiac troponin I. Int. J. Cardiol. 187 (2015), 256–263.
9. [9] Koerbin, G., Tate, J., Potter, J.M., Cavanaugh, J., Glasgow, N., Hickman, P.E., Characterisation of a highly sensitive troponin I assay and its application to a cardio-healthy population. Clin. Chem. Lab. Med. 50 (2012), 871–878.
10. [10] Aw, T.C., Phua, S.K., Tan, S.P., Measurement of cardiac troponin I in serum with a new high-sensitivity assay in a large multi-ethnic Asian cohort and the impact of sex. Clin. Chim. Acta 422 (2013), 26–28.
11. [11] Krintus, M., Kozinski, M., Boudry, P., et al. European multicenter analytical evaluation of the Abbott ARCHITECT STAT high sensitive troponin I immunoassay. Clin. Chem. Lab. Med. 52 (2014), 1657–1665.
12. [12] Collinson, P.O., Gaze, D., Goodacre, S., The clinical and diagnostic performance characteristics of the high sensitivity Abbott cardiac troponin I assay. Clin. Biochem. 59 (2015), 275–281.
13. [13] Lee, K., Lee, S.-Y., Choi, J.-O., Jeon, E.-S., Park, H.-D., The distribution of Abbott high-sensitivity troponin I levels in Korean patients with chest pain. Ann. Clin. Lab. Sci. 45 (2015), 152–157.
14. [14] Rubini Giménez, M., Hoeller, R., Reichlin, T., et al. Rapid rule out of acute myocardial infarction using undetectable levels of high-sensitivity cardiac troponin. Int. J. Cardiol. 168 (2013), 3896–3901.
15. [15] Gassenmaier, T., Buchner, S., Birner, C., et al. High-sensitive troponin I in acute cardiac conditions: implications of baseline and sequential measurements for diagnosis of myocardial infarction. Atherosclerosis 222 (2012), 116–122.
16. [16] Abbott ARCHITECT STAT high sensitive troponin-I. Package Insert. G1-0139/R02, 2013.
17. [17] Gore, M.O., Seliger, S.L., Defilippi, C.R., et al. Age- and sex-dependent upper reference limits for the high-sensitivity cardiac troponin T assay. J. Am. Coll. Cardiol. 63 (2014), 1441–1448.
18. [18] McMurray, J.J.V., Adamopoulos, S., Anker, S.D., et al. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur. J. Heart Fail. 14 (2012), 803–869.
19. [19] International Expert Committee, International Expert Committee report on the role of the A1C assay in the diagnosis of diabetes. Diabetes Care 32 (2009), 1327–1334.
20. [20] Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. http://www.kdigo.org/clinical_practice_guidelines/pdf/CKD/ KDIGO_2012_CKD_ GL.pdf (Accessed July 17, 2015).
21. [21] Levey, A.S., Coresh, J., Greene, T., et al. Using standardized serum creatinine values in the Modification of Diet in Renal Disease Study equation for estimating glomerular filtration rate. Ann. Intern. Med. 145 (2006), 247–254.
22. [22] National Committee for Clinical Laboratory Standards, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline — Second Edition. NCCLS Document EP5-A2. 2004, Wayne, PA, NCCLS.
23. [23] National Committee for Clinical Laboratory Standards, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. NCCLS Document EP6-A. 2003, Wayne, PA, NCCLS.
24. [24] Shrivastava, A., Gupta, V.B., Methods for the determination of limit of detection and limit of quantitation of the analytical methods. Chron. Young Sci. 2 (2011), 21–25.
25. [25] Armbruster, D.A., Pry, T., Limit of blank, limit of detection and limit of quantitation. Clin. Biochem. Rev. 29:Suppl. 1 (2008), S49–S52.
26. [26] Clinical Laboratory Standards Institute, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline — Third Edition. CLSI Document EP28-A3c. 2010, Wayne, PA, CLSI.
27. [27] Reed, A.H., Henry, R.J., Mason, W.B., Influence of statistical method used on the resulting estimate of normal range. Clin. Chem. 17 (1971), 275–284.
28. [28] Kavsak, P.A., Rezanpour, A., Chen, Y., Adeli, K., Assessment of the 99th or 97.5th percentile for cardiac troponin I in a healthy pediatric cohort. Clin. Chem. 60 (2014), 1574–1576.
29. [29] Collinson, P.O., Heung, Y.M., Gaze, D., et al. Influence of population selection on the 99th percentile reference value for cardiac troponin assays. Clin. Chem. 58 (2012), 219–225.
30. [30] Venge, P., Johnston, N., Lindahl, B., et al. Normal plasma levels of cardiac troponin I measured by the high-sensitivity cardiac troponin I access prototype assay and the impact on the diagnosis of myocardial ischemia. J. Am. Coll. Cardiol. 54 (2009), 1165–1172.
31. [31] Normann, J., Mueller, M., Biener, M., et al. Effect of older age on diagnostic and prognostic performance of high-sensitivity troponin T in patients presenting to an emergency department. Am. Heart J. 164 (2012), 698–705.
32. [32] Apple, F.S., A new season for cardiac troponin assays: it's time to keep a scorecard. Clin. Chem. 55 (2009), 1303–1306.
33. [33] Apple, F.S., Jaffe, A.S., Collinson, P., et al. IFCC educational materials on selected analytical and clinical applications of high sensitivity cardiac troponin assays. Clin. Biochem. 48 (2015), 201–203.