A-017 Analytical and Clinical Performance Evaluation of High Sensitivity Cardiac Troponin I hs-cTnI Measurement Through Point of Care
Authors: Paula R F , Ferreira C E , Paladino F V , Lamounier T C , Silva H P , Gomes S R , Caretta B B , Ferreira P R , Mota T P , Melo M B , Pitta F G , Midrigal A D 
Published: September 2023

Background

Most cases of death from Acute Myocardial Infarction (AMI) occur in the first hours after the manifestation of clinical symptoms, constituting 40%–65% in the first hour and approximately 80% in the first 24 h. For the safe, effective, and rapid diagnosis of a patient with suspected AMI, international guidelines recommend that it be done based on clinical symptoms, together with electrocardiogram and analysis of biomarkers in the context of suspected of non–ST-elevation myocardial infarction (NSTEMI). Troponins are the biomarkers of choice with level A level evidence and the ability to perform screening in patients complaining of chest pain and refer it to the correct clinical approach based on the 0 h/1 h algorithm. To date, the successful clinical implementation of these rapid algorithms is restricted to hospitals working with well-defined workflows and a robust central laboratory structure. The Atellica® vTLi analyzer is based on the chemiluminescence methodology for the quantification of hs-cTnI levels with low sample volume, low complexity, and may enable the rapid management of patients with chest pain and application of 0 h/1 h algorithm.

Objectives

Analytical and clinical performance evaluation of high-sensitivity Cardiac Troponin I (hs-cTnI) measurements through point-of-care on the Atellica® vTLi analyzer in patients with suspected AMI compared to the reference methodologies on the market.

Methods

The study is being conducted in the department of Laboratory Medicine, Emergency Department and the Cardiology In the first phase of the study, samples from 80 patients were analyzed for analytical comparability between hs-cTnI of the Analyzer Atellica® vTLi, hs-cTnT Cobas® and hs-cTnI Atellica Solution®. 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 final phase of the study will be performed with samples from 100 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 hs-cTnI Atellica Solution®.

Results

The preliminary results obtained the correlation between the Atellica® vTLi, hs-cTnT Cobas® platforms in the sample group was greater than 0.75. Samples with values that exceeded linearity (less than 3 pg/mL and greater than 1250 pg/mL) were excluded from the analysis. It wasconsidering the reference values of each manufacturer and the biochemical differences of the troponin I and troponin T molecules. The accucary analysis were obtained for QC1 the evaluation range was (13.0–29.1 ng/L) which obtained an average of 17.05, %CV of 7.5 and SD of 1.28. For QC2, the evaluation range was (22.6–51.5 ng/L), which obtained an average of 28.48 ng/L, %CV of 8.68 and SD of 2.47. For QC3, the evaluation range was (238–499 ng/), which obtained an average of 284, 8 ng/L, %CV of 6.65 and SD of 18.90.

Conclusion

The study to date demonstrated a strong correlation between the troponins of the hs-cTnI Atellica® vTLi and hs-cTnT Cobas® analyzers, in addition to safety and accuracy through studies with commercial controls.