AI Article Synopsis
- High-sensitivity troponins are critical for diagnosing Acute Coronary Syndrome without ST-segment elevation, but timing for result delivery is a major concern.
- This study validated the POCT device Atellica® vTLi by analyzing troponin levels in patients, comparing it to established assays (hs-cTnT Cobas®).
- The Atellica® vTLi device demonstrated strong performance and correlation with existing troponin tests, making it suitable for quick chest pain assessment protocols.
Article Abstract
Background: In Acute Coronary Syndrome without ST-segment elevation, the use of high-sensitivity troponins in rapid protocols is considered the gold standard for diagnostic exclusion/confirmation, in conjunction with clinical stratification. The biggest concern regarding the techniques for troponin evaluation is the time required between collection and delivery of the result.
Objective: The objective of the present study is the clinical/laboratory validation of a POCT device for TnI.
Methods: In the first phase of the study, samples from 108 patients with known troponin values High Sensitivity Automated Troponin T (TnT) assay from were analyzed for analytical comparability between hs-cTnI of the Analyzer Atellica® vTLi and hs-cTnT Cobas®. The second phase of the study was performed with samples from 51 patients who reported 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: There was a correlation between the POCT Atellica® vTLi and hs-cTnT Cobas® in the serum samples of the control group (r = 0.660, p < 0.0001). Besides, there was a correlation between the Atellica® vTLi, serum hs-cTnT Cobas®, plasma hs-cTnT Cobas®, serum Atellica IM and plasma Atellica IM 1300 platforms in the second phase (p < 0.0001 in all cases).
Conclusion: In the present study, the Siemens POCT Atellica® vTLi device showed excellent performance in laboratory validation and correlation with the high-sensitivity TnT assay in different troponin concentration ranges. Given these results, the device can be used in institutions that intend to use a POCT device for 0- and 1-hour chest pain protocols.
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Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11661013 | PMC |
| http://dx.doi.org/10.5334/gh.1377 | DOI Listing |
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