Clin Res Cardiol (2021)
DOI DOI https://doi.org/10.1007/s00392-021-01843-w
Evaluation of a novel high-sensitivity cardiac troponin I assay
N. A. Sörensen1, J. Neumann1, A. Goßling1, T. Hartikainen1, P. Haller1, L. Scharlemann1, J. Lehmacher1, A. Ziegler1, S. Blankenberg1, T. Zeller1, G. Nordholt2, T. Renné2, D. Westermann1, für die Studiengruppe: BACC
1Klinik und Poliklinik für Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 2Institut für Klinische Chemie und Laboratoriumsmedizin, Universitätsklinikum Hamburg-Eppendorf, Hamburg;

Background: Rapid diagnosis of patients with suspected myocardial infarction (MI) based on high-sensitivity troponin is increasingly adapted in emergency departments worldwide and is endorsed in recent international guidelines. So far, the novel Siemens Atellica IM High-Sensitivity Troponin I (hs-cTnI) has not been sufficiently evaluated for the use in a rapid diagnostic algorithm.

Methods: In a cohort study including 1,800 patients presenting with suspected acute MI, we developed and temporally validated a 0/1h diagnostic algorithm using the novel hs-cTnI assay. The algorithm was established in the first 928 patients and validated in the following 872 patients.

Results: The derived 0/1h algorithm consisted of an admission troponin I <6 ng/L and an increase from 0h to 1h <3 ng/L for rule-out and an admission troponin I ≥120 ng/L or an increase within the first hour ≥12 ng/L for rule-in of non-ST elevation MI. Application of the algorithm to the validation cohort showed a negative predictive value of 99.8% (95% confidence interval (CI) 98.6%-100.0%), a sensitivity of 99.1% (CI 95.1%–100.0%) and 48.3% of patients ruled out, whereas 15.1% were ruled in with a positive predictive value of 68.0% (CI 59.1%-75.9%) and a specificity of 94.4% (92.5%–96.0%) (Table 1). Correlation of the Siemens Atellica hs-cTnI-results with the well-established Abbott Architect STAT High Sensitive Troponin-I assay was high, and the performance of the developed algorithm was similar to guideline-recommended application of the Abbott hs-cTnI assay in a rapid 0/1h strategy.

Conclusion: The novel Siemens Atellica IM High-Sensitivity Troponin I assay showed good diagnostic performance and its application in a rapid diagnostic algorithm is feasible.

Table 1: Rule-out and rule-in of non-ST elevation MI in the derivation and validation cohort

 


 Percent of all
(%)
 Sensitivity
(%)		  Specificity
(%)		 NPV
(%)
Event rates
(%)
 Rule-Out  0h*  Derivation  0h hs-cTnI
<3 ng/L 		 29.3  98.9
(93.8–100.0)		  34.1
(30.0–38.4)		  99.4
(96.9–100.0)		 1.1
(0.0–2.7)
 Validation  25.7 100
(95.1–100.0)
 29.5
(25.5–33.8)		  100
(97.5–100.0)		  0.0
(0.0-0.0)
 0h-1h  Derivation  hs-cTnI
0h <6 ng/L and Delta 0h-1h
<3 ng/L
  51.4 97.9
(93.9–99.6)
 60.7
(57.1–64.2)		 99.3
(98.1–99.9)		  2.0
(0.7–3.2)
 Validation 48.3
 99.1
(95.1–100.0)		  55.5
(51.8–59.1)		  99.8
(98.6–100.0)		  0.6
(0.0–1.4)
  Percent of all
(%)
  Sensitivity
(%)		 Specificity
(%)
PPV
(%)		  Event rates
(%)
Rule-In
0h-1h
 Derivation hs-cTnI
0h ≥120 ng/L or Delta 0h-1h
≥12 ng/L
 17.6  78.7
(71.0–85.2)		  94.0
(92.0–95.6)		 71.2
(63.4–78.1)
12.9
(7.4–18.0)
 Validation  15.1  78.4
(69.6–85.6)		  94.4
(92.5–96.0)		  68.0
(59.1–75.9)		  9.1
(3.3, 14.6)
 

*For 0h rule-out only individuals with a symptom onset over 3h before presentation were used. 95% confidence intervals are given in parenthesis. hs-cTnI: high-sensitivity troponin I, NPV: negative predictive value, PPV: positive predictive value

 
https://dgk.org/kongress_programme/jt2021/aP625.html