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Pivotal findings for a high-sensitivity cardiac troponin assay: Results of the HIGH-US study.

Publication ,  Journal Article
Christenson, RH; Duh, S-H; Apple, FA; Nowak, R; Peacock, WF; Limkakeng, AT; Bostanian, Z; Mohammad, A; McCord, J; deFilippi, CR
Published in: Clin Biochem
April 2020

BACKGROUND: Cardiac troponin (cTn) is the keystone for diagnosis of acute myocardial infarction (AMI). We examined the analytical and diagnostic accuracy of the Atellica IM TnIH assay to determine high-sensitivity performance and appropriate diagnostic performance for clinical use. METHODS: Sex-specific 99th percentile upper reference limits (URLs) were determined for a healthy cohort of 1007 women and 1000 men using non-parametric statistics. High-sensitivity performance was assessed by examining if imprecision was ≤10% at sex-specific URLs and if ≥50% of cTnI values for each sex exceeded the assay's limit of detection (LoD) with the AACC Universal Sample Bank. Precision, high-dose hook effect, endogenous/exogenous interferences were examined with CLSI guidance. Clinical characterization was with 2494 suspected AMI subjects presenting to emergency departments across the United States. AMI was adjudicated by expert cardiologists and emergency medicine physicians. There were no comorbidity exclusions. RESULTS: 99th percentile URLs were 34 ng/L, 53 ng/L and 45 ng/L for the female, male and overall populations, respectively. Total imprecision was <5% from 12 ng/L to 16,000 ng/L; ≥55% of cTnI values for each sex exceeded the LoD. No high-dose hook or endogenous/exogenous interferences were identified. After 2.5-3.5 h post presentation the sensitivity and specificity were >90%; negative and positive predictive value were ≥98% and >60%, respectively. Non-AMI subjects with comorbidities and values exceeding 99th percentile URLs had absolute and percent change at 2-4 h that were lower than AMI patients with comorbidities (p = 0.001). CONCLUSION: The Atellica IM TnIH assay is a high-sensitivity method and demonstrates clinical performance appropriate for AMI diagnosis.

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Published In

Clin Biochem

DOI

EISSN

1873-2933

Publication Date

April 2020

Volume

78

Start / End Page

32 / 39

Location

United States

Related Subject Headings

  • Young Adult
  • Troponin I
  • Sex Factors
  • Sensitivity and Specificity
  • ROC Curve
  • Middle Aged
  • Male
  • Limit of Detection
  • Humans
  • General Clinical Medicine
 

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Christenson, R. H., Duh, S.-H., Apple, F. A., Nowak, R., Peacock, W. F., Limkakeng, A. T., … deFilippi, C. R. (2020). Pivotal findings for a high-sensitivity cardiac troponin assay: Results of the HIGH-US study. Clin Biochem, 78, 32–39. https://doi.org/10.1016/j.clinbiochem.2019.10.013
Christenson, Robert H., Show-Hong Duh, Fred A. Apple, Richard Nowak, W Frank Peacock, A. T. Limkakeng, Zohrab Bostanian, Amin Mohammad, James McCord, and Christopher R. deFilippi. “Pivotal findings for a high-sensitivity cardiac troponin assay: Results of the HIGH-US study.Clin Biochem 78 (April 2020): 32–39. https://doi.org/10.1016/j.clinbiochem.2019.10.013.
Christenson RH, Duh S-H, Apple FA, Nowak R, Peacock WF, Limkakeng AT, et al. Pivotal findings for a high-sensitivity cardiac troponin assay: Results of the HIGH-US study. Clin Biochem. 2020 Apr;78:32–9.
Christenson, Robert H., et al. “Pivotal findings for a high-sensitivity cardiac troponin assay: Results of the HIGH-US study.Clin Biochem, vol. 78, Apr. 2020, pp. 32–39. Pubmed, doi:10.1016/j.clinbiochem.2019.10.013.
Christenson RH, Duh S-H, Apple FA, Nowak R, Peacock WF, Limkakeng AT, Bostanian Z, Mohammad A, McCord J, deFilippi CR. Pivotal findings for a high-sensitivity cardiac troponin assay: Results of the HIGH-US study. Clin Biochem. 2020 Apr;78:32–39.
Journal cover image

Published In

Clin Biochem

DOI

EISSN

1873-2933

Publication Date

April 2020

Volume

78

Start / End Page

32 / 39

Location

United States

Related Subject Headings

  • Young Adult
  • Troponin I
  • Sex Factors
  • Sensitivity and Specificity
  • ROC Curve
  • Middle Aged
  • Male
  • Limit of Detection
  • Humans
  • General Clinical Medicine