Diagnostic Validation of a High-Sensitivity Cardiac Troponin I Assay
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Diagnostic Validation of a High-Sensitivity Cardiac Troponin I Assay. / Sörensen, Nils A; Goßling, Alina; Neumann, Johannes T; Hartikainen, Tau S; Haller, Paul M; Scharlemann, Lea; Lehmacher, Jonas; Ziegler, Andreas; Blankenberg, Stefan; Zeller, Tanja; Nordholt, Gerhard; Renné, Thomas; Westermann, Dirk.
In: CLIN CHEM, Vol. 67, No. 9, 01.09.2021, p. 1230-1239.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Diagnostic Validation of a High-Sensitivity Cardiac Troponin I Assay
AU - Sörensen, Nils A
AU - Goßling, Alina
AU - Neumann, Johannes T
AU - Hartikainen, Tau S
AU - Haller, Paul M
AU - Scharlemann, Lea
AU - Lehmacher, Jonas
AU - Ziegler, Andreas
AU - Blankenberg, Stefan
AU - Zeller, Tanja
AU - Nordholt, Gerhard
AU - Renné, Thomas
AU - Westermann, Dirk
N1 - © American Association for Clinical Chemistry 2021. All rights reserved. For permissions, please email: journals.permissions@oup.com.
PY - 2021/9/1
Y1 - 2021/9/1
N2 - BACKGROUND: Emergency departments worldwide are increasingly adopting rapid diagnosis of patients with suspected myocardial infarction (MI) based on high-sensitivity troponin. We set out to assess the diagnostic accuracy of a high-sensitivity cardiac troponin I (hs-cTnI) assay in a prospective study.METHODS: In a cohort study including 1800 patients presenting with suspected acute MI, we developed and temporally validated a 0/1 h diagnostic algorithm using the Siemens Atellica IM hs-cTnI assay. The algorithm was established in the first 928 patients and validated in the following 872 patients.RESULTS: The derived algorithm consisted of a baseline rule-out of non-ST-segment elevation MI using a cutoff <3 ng/L in patients with symptom onset ≥3 h or an admission troponin I level <6 ng/L with a Δ change of <3 ng/L from 0 h to 1 h. For rule-in, an admission troponin I level ≥120 ng/L or an increase within the first hour ≥12 ng/L was required. Application of the algorithm to the validation cohort showed a negative predictive value of 99.8% (95% CI, 98.7%-100.0%), sensitivity of 99.1% (95% 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% (95% CI, 59.1%-75.9%) and specificity of 94.4% (95% CI, 92.5%-96.0%). The diagnostic performance was comparable to guideline-recommended application of an established hs-cTnI assay in a rapid 0/1 h strategy.CONCLUSIONS: The Siemens hs-cTnI assay is well suited for application in rapid diagnostic stratification of patients with suspected MI.STUDY REGISTRATION: www.clinicaltrials.gov (NCT02355457).
AB - BACKGROUND: Emergency departments worldwide are increasingly adopting rapid diagnosis of patients with suspected myocardial infarction (MI) based on high-sensitivity troponin. We set out to assess the diagnostic accuracy of a high-sensitivity cardiac troponin I (hs-cTnI) assay in a prospective study.METHODS: In a cohort study including 1800 patients presenting with suspected acute MI, we developed and temporally validated a 0/1 h diagnostic algorithm using the Siemens Atellica IM hs-cTnI assay. The algorithm was established in the first 928 patients and validated in the following 872 patients.RESULTS: The derived algorithm consisted of a baseline rule-out of non-ST-segment elevation MI using a cutoff <3 ng/L in patients with symptom onset ≥3 h or an admission troponin I level <6 ng/L with a Δ change of <3 ng/L from 0 h to 1 h. For rule-in, an admission troponin I level ≥120 ng/L or an increase within the first hour ≥12 ng/L was required. Application of the algorithm to the validation cohort showed a negative predictive value of 99.8% (95% CI, 98.7%-100.0%), sensitivity of 99.1% (95% 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% (95% CI, 59.1%-75.9%) and specificity of 94.4% (95% CI, 92.5%-96.0%). The diagnostic performance was comparable to guideline-recommended application of an established hs-cTnI assay in a rapid 0/1 h strategy.CONCLUSIONS: The Siemens hs-cTnI assay is well suited for application in rapid diagnostic stratification of patients with suspected MI.STUDY REGISTRATION: www.clinicaltrials.gov (NCT02355457).
U2 - 10.1093/clinchem/hvab070
DO - 10.1093/clinchem/hvab070
M3 - SCORING: Journal article
C2 - 34254126
VL - 67
SP - 1230
EP - 1239
JO - CLIN CHEM
JF - CLIN CHEM
SN - 0009-9147
IS - 9
ER -