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Analytical and Clinical Considerations in Implementing the Roche Elecsys Troponin T Gen 5 STAT Assay
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Analytical and Clinical Considerations in Implementing the Roche Elecsys Troponin T Gen 5 STAT Assay
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Journal Article
Analytical and Clinical Considerations in Implementing the Roche Elecsys Troponin T Gen 5 STAT Assay
2021
Overview
Abstract
Objectives
To evaluate the analytical and clinical performance characteristics of the fifth-generation troponin T reagent.
Methods
Troponin T was measured in 2,332 paired serum and plasma samples from emergency department and hospital patients using the fourth- and fifth-generation reagents. Testing was repeated after recentrifugation to determine the frequency of analytical outliers and percentage of patients with elevated values for each assay. We conducted separate experiments to determine the effects of biotin and hemolysis interference, as well as measure interinstrument variability, for fifth-generation troponin T.
Results
Analytic outliers occurred more frequently using the fifth-generation reagent (3.4%) compared with the fourth-generation reagent (1.0%). The frequency of elevated troponin T above the 99th percentile upper reference limit was 26% for the fourth-generation reagent and 52% for the fifth-generation reagent. Clinically significant assay interference by biotin was observed at 20 ng/mL, but hemolysis interference was not observed until an H index of 150. Instrument-to-instrument variability between e411 and e601/602 instrument platforms is predicted to confound clinical interpretation of troponin changes.
Conclusions
Analytical outliers and instrument-to-instrument variability are the two analytical variables most likely to confound interpretation of changes in fifth-generation troponin T results over time.
Publisher
Oxford University Press
Subject
