Time-related performance characteristics of high-sensitivity troponin I assay using manufacturer’s controls and reagents

Abstract Background Troponin is a widely used cardiac protein biomarker for acute coronary syndrome. Its increasing importance drives an increasing need to assess, in real-world conditions, the performance of the tests to measure it. We evaluated the performance characteristics of high-sensitivity troponin I assay reagents and ancillary agents on the Abbott ARCHITECT ci4100, ARCHITECT i2000SR and Alinity ci using historical quality control data spanning 5 years. Design and Method Retrospective diagnostic hs-TnI quality control data were collected between 2015 and 2019 from the Abbott ARCHITECT ci4100, ARCHITECT i2000SR and Alinity ci located in the University College Dublin Clinical Research Centre Core Lab facility. Descriptive statistics for bias and variability were generated. Linear regression models were used to calculate the mean hs-TnI concentrations over Abbott quality control or reagent lot age and over time from the last calibration of the analysers. Results Measurement bias on all three systems ranged between -3.08% and 4.34%. The total CV was ≤9.38%, with a within-lot variability for the reagents of ≤7.16% and ≤8.37% for control lots. The between-lot CVs for reagents and controls were ≤7.46% and ≤5.94% respectively. The effect of control or reagent age did not greatly affect stability over time. Results were also stable over different times from the last calibration of the analysers. Conclusion The results of this study show that the Abbott hs-TnI assay on the ARCHITECT i2000sr and ARCHITECT ci4000 Systems is quite stable in a core laboratory environment. The Alinity ci System exhibits similar performance characteristics.