Diagnostic Validation of a High-Sensitivity Cardiac Troponin I Assay

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 -