Single High-Sensitivity Point-of-Care Whole-Blood Cardiac Troponin I Measurement to Rule Out Acute Myocardial Infarction at Low Risk

Abstract

Background: High-sensitivity cardiac troponin (hs-cTn) laboratory assays are used to rule out myocardial infarction (MI) on presentation, but prolonged result turn-around times can delay patient management. Our primary aim was to identify patients at low risk of index MI using a rapid, point of care (POC), whole blood hs-cTnI assay at presentation, with potential early patient discharge. Methods: Consecutive emergency department patients from two prospective, observational studies with suspected acute coronary syndrome were enrolled. A POC hs-cTnI assay (Atellica ® VTLi) threshold using whole blood at presentation, that resulted in a negative predictive value (NPV) of ≥99.5% and sensitivity of ≥99% for index MI, was derived (Safe Emergency department dIscharGE rate [SEIGE]) and validated using plasma (Suspected acute myocardial infarction in Emergency [SAMIE]). Event adjudications were established using hs-cTnI assay results from routine clinical care. The primary outcome was MI at 30-days. Results: 1086 patients (8.1% MI) were enrolled in a US derivation cohort (SEIGE) and 1486 (5.5% MI) in an Australian validation cohort (SAMIE). A derivation whole blood POC hs-cTnI concentration of <4ng/L provided a sensitivity of 98.9% (93.8-100%) and NPV of 99.5% (95% CI: 97.2-100%) for ruling out MI. In the validation cohort, sensitivity was 98.8% (93.3-100%) and NPV was 99.8% (99.1-100%). 17.8% and 41.8%, respectively, were defined as low risk for discharge. 30-day adverse cardiac events were 0.1% (n=1) for SEIGE and 0.8% (n=5) for SAMIE. Conclusions: A point-of-care, whole blood hs-cTnI assay permits an accessible, rapid and safe exclusion of MI, and may expedite discharge from the emergency department.

Optimizing the Clinical Use of High-Sensitivity Troponin Assays: A Review

“…The most promising is the Atellica VTLi, with its analytical performance rigorously assessed in plasma and whole blood [ 79 ]. The Atellica’s clinical performance has been derived and validated in a US cohort (whole blood, n = 1086) against the Abbott hsTnI and in Australia (plasma, n = 1486) against the Beckman hs-cTnI [ 80 ]. Using a hs-TnI of < 4 ng/L, the Atellica identified patients at low risk of MI, death (cardiac and all-cause) and unplanned revascularization at 30 days.…”

Real-life evaluation of hypersensitive I-troponin on a point-of care analyser in an emergency unit

“…Aucun des patients ayant bénéficié d'une cinétique de Tn-hs n'a une valeur initiale de TnI-hs inférieure à la limite de détection (1,6 ng/L). Très récemment, une étude a démontré qu'une valeur de TnI-hs, réalisée sur l'Atellica VTLI ® en sang total, strictement inférieure à 4 ng/L avait une valeur prédictive négative de 99,5 % pour le diagnostic de l'infarctus du myocarde [39]. Tous les patients ayant une valeur élevée de TnT-hs (>52 ng/L) ont une valeur de TnI-hs supérieure au 99 e percentile.…”

Protocol for Improving Care by FAster risk-STratification through use of high sensitivity point-of-care troponin in patients presenting with possible acute coronary syndrome in the EmeRgency department (ICare-FASTER): a stepped-wedge cluster randomised quality improvement initiative

“…Several manufacturers have now received regulatory approval for POC-cTnI assays that have similar analytical precision at low-concentrations of cTn as central laboratory hs-cTn assays and use an unspun whole blood sample. [6][7][8][9] Consequently, low-risk stratification of AMI with a POC-cTnI assay using a single low-concentration threshold is now possible. 9…”

“…[6][7][8][9] Consequently, low-risk stratification of AMI with a POC-cTnI assay using a single low-concentration threshold is now possible. 9…”