Analytical assays and bootstrap resampling method to validate performance of the Roche Elecsys STAT highly sensitive troponin T assay and its application for the ‘rule-out’ part of ESC guidelines for NTSTEMI

Abstract

Background The European Society of Cardiology (ESC) guidelines recommend a dynamic (0-1h) cardiac troponin (cTn) determination for non-ST elevation myocardial infarction diagnosis. For patients with low cTn levels, a discharge from emergency can be considered. Nevertheless, cTn cutoffs for discharge are lower than the limits of quantification proposed by laboratory reagent suppliers. Aim Validate cTn assay on the Elecsys STAT kit. Materials and methods Precision, trueness, repeatability and within-laboratory variability were calculated from internal quality control and plasma pooled at 5.78 and 10.73 ng/L. Accuracy was calculated from external quality control. Uncertainty of measurement was calculated from (i) the uncertainty of the standard and control values and (ii) by precision from pooled plasma. Distribution of precision results from pooled plasma has been evaluated by bootstrap simulations. Dilution linearity tests with patient plasma were performed to evaluate the method for values near 5 ng/L. Results Precision and trueness ranged from 1.35 to 4.45% and from 0.14 to −3.74%, respectively. Accuracy results ranged from 101.40 to 104.90%. Within laboratory variability was 2.91%. Uncertainty ranged from 3.66% to 19.90% for higher (2188) to lower values (5.78 ng/L). Bootstrap simulations allowed utilization of precision data from pooled plasma to evaluate cTn assay. The method was linear from 4.48 to 39.80 ng/L. A linear regression model best described the data. Conclusion Elecsys STAT method provides accurate cTn results, including patients with cTn results categorizing them as ‘rule-out’ in the ESC guidelines.