A-371 Analytical Comparison of Point-of-Care and Laboratory-Based High-Sensitivity Troponin I Assays

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Abstract Background Cardiovascular disease, particularly acute coronary syndrome (ACS), imposes a significant burden on patients, clinicians, and healthcare systems. Chest pain is one of the most common reasons for emergency department (ED) visits worldwide, with suspected ACS cases accounting for approximately 10% of all emergency presentations. Advances in clinical care rely heavily on high-sensitivity cardiac troponin (hs-cTn) assays, which enable the detection of myocardial injury with high precision. While these assays are primarily used in centralized hospital laboratories, recent developments have improved the accuracy and precision of point-of-care (POC) hs-cTn assays, making them a potential alternative. This study evaluates the analytical performance of a POC hs-cTnI assay by comparing its results with those obtained from the gold-standard, automated central laboratory testing. Methods A total of 23 random whole blood patient samples were collected from the ED. A POC hs-cTnI assay (PATHFAST) using whole blood at presentation was compared with lithium heparin plasma samples after centrifugation, analyzed on both the PATHFAST and Siemens Atellica IM analyzers. Analytical comparisons were conducted using Passing-Bablok regression and Bland-Altman analysis. Results Results from whole blood on the PATHFAST analyzer were approximately 16% lower than those from lithium heparin plasma on the Siemens Atellica, with a correlation coefficient (R) of 0.8799. Bland-Altman analysis showed that most differences fell within the 95% limits of agreement (-70% to 43%). Comparatively, results in lithium heparin plasma were about 23% lower than whole blood results on the PATHFAST analyzer, with a correlation coefficient (R) of 0.9877. Bland-Altman analysis demonstrated that most differences were within the 95% limits of agreement (-48% to -9%). Conclusion The results suggest that while there are some discrepancies between the point-of-care (POC) hs-cTnI assay (PATHFAST) and the central laboratory analyzer (Siemens Atellica), the correlation between the two methods is generally strong. The whole blood samples tested on the PATHFAST analyzer show a consistent, though slightly lower, value compared to lithium heparin plasma on the Siemens Atellica, with most differences falling within acceptable limits of agreement. Given the high correlation between the two platforms, the PATHFAST POC hs-cTnI assay demonstrates reliable analytical performance for rapid myocardial injury detection in the clinical setting, making it a viable alternative to laboratory-based testing for ACS diagnosis. However, re-baselining and further validation across larger patient cohorts may be necessary to ensure full clinical applicability and minimize variability.

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