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Details

Autor(en) / Beteiligte
Titel
Diagnostic Validation of a High-Sensitivity Cardiac Troponin I Assay
Ist Teil von
  • Clinical chemistry (Baltimore, Md.), 2021-09, Vol.67 (9), p.1230-1239
Ort / Verlag
England: Oxford University Press
Erscheinungsjahr
2021
Link zum Volltext
Quelle
Oxford Journals 2020 Medicine
Beschreibungen/Notizen
  • Abstract 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)

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