A-004 Clinical and Laboratory Validation of the Atellica® vTLi Analyzer for Diagnosis of Myocardial Infarction Through High Sensitivity Cardiac Troponin I (hs-cTnI) Measurement

Abstract

Abstract Background Most deaths resulting from Acute Myocardial Infarction (AMI) occur within the initial hours following the onset of clinical symptoms. Troponins serve as the preferred biomarkers and can be utilized for screening individuals presenting with chest pain, referring them towards appropriate clinical interventions based on the 0-hour/1-hour algorithm. The Atellica® vTLi Patient-side analyzer (POC), employing the methodology based Magnotech™ Technology, allows the quantification of hs-cTnI levels using a small sample volume. This capability enables the prompt evaluation and management of patients with chest pain. Use POCT troponin assays may allow for faster decision-making in this high-risk population and reduce the burden on emergency facilities. This study evaluated the analytical and clinical performance of a POCT hs-cTnI from Atellica® VTLi compared to hs-cTnT Roche Diagnostics and hs-cTnI Atellica® IM 1300. Objectives Clinical and analytical validation of the Atellica® vTLi analyzer for the measurement of hs-cTnI in patients with suspected AMI compared to the reference methodologies on the market. Methods The study is being conducted in the department of critically patient, the Cardiology program and the clinical laboratory of the Hospital Israelita Albert Einstein. In the first phase of the study, samples from 108 volunteers were analyzed for analytical comparability between hs-cTnI of the Analyzer Atellica® vTLi and hs-cTnT Cobas®. A study was then carried out of precision with samples of commercial controls with three evaluation levels, with five replicates, for 5 days in the Analyzer Atellica® vTLi. The second phase of the study was performed with samples from 51 patients who report to the emergency department with chest pain for a clinical prospective evaluation and correlation between the hs-cTnI assays of the Analyzer Atellica® vTLi, hs-cTnT Cobas® and Atellica IM 1300. Results The results show a great correlation (Pearson’s correlation greater than 0.75, p<0.0001) between the Atellica® vTLi, hs-cTnT Cobas® platforms in the sample group. Of the patients included in the second phase of study, the average age was 61 years, with 60% of patients having systemic arterial hypertension, 35% diabetics, 53% dyslipidemic patients and none of the patients were smokers. When assessing cardiovascular risk using the heart score, 55% of patients were at moderate or high risk. In this group there was also a strong correlation between the Atellica® vTLi platforms, hs-cTnT Cobas® serum, hs-cTnT Cobas® plasma, Atellica IM 1300 serum and Atellica IM 1300 plasma in the second phase (p<0.0001 in all cases. Pearson correlation), considering the reference values for laboratory stratification in the rapid chest pain protocol (time 0 h and 1 h) and the biochemical differences of troponin I and troponin T molecules. Conclusions In the present study, the Siemens POCT Atellica® vTLi device showed excellent performance in laboratory validation and strong correlation with the high-sensitivity TnT assay in different troponin concentration ranges. Additionally, Atellica® vTLi demonstrated a strong clinical correlation between hs-cTnI Atellica® IM 1300 and hs-cTnT Cobas® platforms present in a central laboratory, being considered safe for use in 0-1h protocols in patients with chest pain and suspected heart attack.