Multicenter analytical evaluation of a high-sensitivity troponin T assay

Saenger, Amy K.; Beyrau, Ralf; Braun, Siegmund; Cooray, R.; Dolci, Alberto; Freidank, Heike; Giannitsis, Evangelos; Gustafson, Steven A.; Handy, Beverly Carol; Katus, Hugo A.; Melanson, Stacy E.F.; Panteghini, Mauro; Venge, Per; Zorn, Markus; Jarolím, Petr; Bruton, D.; Jarausch, Jochen; Jaffe, Allan S.

doi:10.1016/j.cca.2010.12.034

Cited by 326 publications

(228 citation statements)

References 26 publications

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“…This finding was confirmed in studies using the highly sensitive cTnI method [14,27]. The progressive increase of circulating cTnT levels in apparently healthy adult subjects over 65 years was confirmed in the same period, when the highly sensitive ECLIA method became commercially available [11,12,26,[35][36][37]. In their study on a total of 651 subjects admitted to emergency department (ED) without evident conditions known to increase cTnT, Hammarsten et al [36] found cTnT values over the cut-off (i.e.…”

Section: Agementioning

confidence: 67%

“…Regarding the highly sensitive cTnT ECLIA method, variability among the 99th URL values reported in different studies and by manufacturers is very similar (Table 5) [9,12,26,41,124,[126][127][128]. Considering as a whole the clinical studies including a total of 10,078 individuals [9,12,26,47,124,[126][127][128], median (25th-75th percentiles) values of 99th URL results of highly sensitive cTnT ECLIA method are for the overall population 14.6 (13.2-18.0) ng/L, for men 16.0 (15.0-19.5) ng/L, and for women 12.0 (9.6-12.5) ng/L, respectively.…”

Section: Do Differences In Troponin-dependent 99th Url Values Depend mentioning

confidence: 85%

“…Considering as a whole the clinical studies including a total of 10,078 individuals [9,12,26,47,124,[126][127][128], median (25th-75th percentiles) values of 99th URL results of highly sensitive cTnT ECLIA method are for the overall population 14.6 (13.2-18.0) ng/L, for men 16.0 (15.0-19.5) ng/L, and for women 12.0 (9.6-12.5) ng/L, respectively. The results reported by Gaggin et al [128], including data related to two different populations (i.e.…”

Section: Do Differences In Troponin-dependent 99th Url Values Depend mentioning

confidence: 99%

“…Given that cTnI has a lower molecular mass than cTnT (about 22,000 vs. 37,000 Da) [129], the results reported in various studies [9,12,26,47,120,[122][123][124] indicate that there is a larger number of circulating cTnI-related molecules than cTnT-related molecules in healthy subjects. Furthermore, since cTnI and cTnT are present in the sarcomeric complex in a molecular ratio of 1:1, these differences between the circulating cTns are probably related to differences in intra- [130] or extra-cellular [131][132][133] catabolism and the peripheral turnover of cTnI and cTnT.…”

Section: Do Differences In Troponin-dependent 99th Url Values Depend mentioning

confidence: 99%

“…However, measurement of the 99th URL of cTnI and cTnT levels is a challenging analytical issue due to low biomarker concentrations present in healthy subjects [7][8][9]. Only after 2006 some manufacturers set-up the first new generation of cTnI and cTnT immunoassays with improved analytical sensitivity in accordance with the quality specifications indicated in international guidelines and consensus documents [4,[6][7][8][9][10][11][12][13][14][15][16]. Importantly, highly sensitive methods should also be able to measure troponin levels in the majority of healthy adults subjects (>50%), as suggested in some consensus documents [16][17][18].…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

The 99th percentile of reference population for cTnI and cTnT assay: methodology, pathophysiology and clinical implications

Clerico

Zaninotto

Ripoli

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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According to recent international guidelines, including the 2012 Third Universal Definiton of Myocardial Infarction by the Joint ESC/ACCF/AHA/WHF Task Force, an increase in cardiac troponin (cTn) levels over the 99th percentile upper reference limit (99th URL) should be considered clinically relevant, this cut-off being measured with an imprecision ≤10 CV%. In theory 99th URL values strongly depend not only on demographic and physiological variables (i.e. criteria for considering the reference population "healthy"), but also on the analytical performance of cTn methods and mathematical algorithms used for the calculation. The aim of the present article was therefore to review the methodological and pathophysiological factors affecting the evaluation and calculation of the 99th URL for cTn assay. The critical analysis made showed that no uniform procedure is followed, and nor have experts or regulatory bodies provided uniform guidelines for researchers or cTn assays manufacturers as an aid in "their quest to define normality". In particular, little attention has been paid to the way in which a healthy reference population is to be selected, or the criteria for calculating the 99th URL value for cTn assays, thus highlighting the need for international recommendations not only for demographic and physiological variables criteria for defining a healthy reference population, but also for calculating mathematical algorithms for establishing/ calculating clinical decision values. An expert consensus group, comprising laboratory and clinical scientists, biomedical statisticians, industrial and regulatory representatives, should be responsible for drawing up these guidelines.

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