Diagnostic accuracy of a high-sensitivity troponin I assay and external validation of 0/3 h rule out strategies

Abstract

Abstract Aims  The timely diagnosis and exclusion of acute coronary syndromes in the Emergency Department (ED) remains a challenge. This study aims to evaluate the diagnostic accuracy of a high-sensitivity cardiac troponin I assay (Siemens TNIH) on serial sampling for ED patients as standalone test and in rule-out algorithms as recommendations remain assay specific. Methods and results  This secondary analysis from a prospective diagnostic accuracy study at 14 centres included ED patients presenting with chest pain of suspected cardiac nature. Serum drawn on arrival and 3 h later was batchtested for TNIH. The target condition was an adjudicated diagnosis of acute myocardial infarction (AMI). We evaluated the diagnostic accuracy of absolute and relative delta criteria and four rule-out strategies. Of 802 included patients, 13.8% had AMI. Absolute delta criteria had superior accuracy to relative criteria (C-statistic 0.94 vs. 0.76, P < 0.001). However, no delta criteria achieved >95.5% sensitivity for AMI when used alone. Ruling out AMI with TNIH below the 99th percentile at 0 and 3 h had 88.3% (95% confidence interval 80.8–93.6%) sensitivity. The adapted European Society of Cardiology (ESC) 0/2 h algorithm had higher sensitivity (98.2%) than both High-STEACS (93.7%, P = 0.03) and the ESC 0/3 h algorithm (79.3%, P < 0.001). These pathways ruled out 63%, 74%, and 88% patients, respectively. Conclusion  With serial sampling over 3 h, the Siemens TNIH assay should be used with a validated algorithm incorporating bespoke cut-offs and absolute delta criteria. In our analysis, the adapted ESC 0/2 h algorithm had greatest sensitivity. ‘Ruling out’ AMI using the 99th percentile of the assay cannot be recommended.