Key result
The high-sensitive cTnI assay yielded fewer samples below the detection limit than the ultra-sensitive assay (6.1% vs 25.9%) and detected 96 additional cases related to heart disorder.
Why the study?
Little had been done to systematically compare older ultra-sensitive and newer high-sensitive troponin I assays, and validation of hs-cTnI was needed.
Does the high-sensitive cTnI assay improve the detection of heart disorders compared to the ultra-sensitive cTnI assay in patient serum samples?
Cross-Sectional (n=8,810)
No
Does the high-sensitive cTnI assay improve the detection of heart disorders compared to the ultra-sensitive cTnI assay in patient serum samples?
Absolute Event Rate: 6.1% vs 25.9%
The high-sensitive cTnI assay demonstrates superior analytical sensitivity and clinical detection of heart disorders compared to the older ultra-sensitive assay, supporting its deployment in laboratory settings.
May support high-sensitive cTnI adoption in labs; leaves open effects on clinical outcomes.
Cardiac troponin I (cTnI) is a standard biomarker for the diagnosis of acute myocardial infarction (AMI). While older, ultra-sensitive cTnI (us-cTnI) assays use the 99th percentile as the reference threshold, newer high-sensitive cTnI (hs-cTnI) assays use the limit of detection or functional sensitivity instead. However, little has been done to systematically compare these two methods. The present study also served as a validation of hs-cTnI in our laboratory. Here, we compared the results obtained from the blood serum obtained from 8810 patients using the us-cTnI and the hs-cTnI assays run in tandem on the ADVIA Centaur XP analyser. We found that in 2279 samples the concentration of cTnI measured with the ultra-sensitive method was below the detection limit, while with the high-sensitive method, only 540 were below the detection limit. We also compared results from these assays with the ultimate diagnosis of a subset of individuals. The analysis of the results below cut-off with the ultra-sensitive method showed that this method would not detect 96 cases related to heart disorder. Overall, the main finding of our research is that hs-cTnI is the preferable option and is able to be deployed effectively in the laboratory setting.
No takes yet. Share an insight, caveat, or question.
Osredkar et al. (2022) conducted a cross-sectional in Acute myocardial infarction (AMI) (n=8,810). High-sensitive cTnI (hs-cTnI) assay vs. Ultra-sensitive cTnI (us-cTnI) assay was evaluated on Samples with cTnI concentration below the detection limit. The high-sensitive cTnI assay yielded fewer samples below the detection limit than the ultra-sensitive assay (6.1% vs 25.9%) and detected 96 additional cases related to heart disorder.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: