Why the study?
Is characterizing analytical sensitivity as a continuous variable more appropriate than the dichotomous classification of sensitive vs highly-sensitive for cardiac troponin assays?
Is characterizing analytical sensitivity as a continuous variable more appropriate than the dichotomous classification of sensitive vs highly-sensitive for cardiac troponin assays?
The study suggests that classifying cardiac troponin assays as 'sensitive' or 'highly-sensitive' is theoretically flawed, and analytical sensitivity should instead be characterized as a continuous variable.
Questions binary sensitive vs highly-sensitive cTnI assay labels; supports continuous sensitivity characterization in future validation studies.
BACKGROUND: Highly-sensitive cardiac troponin (cTn) assays are being introduced into the market. In this study we argue that the classification of cTn assays into sensitive and highly-sensitive is flawed and recommend a more appropriate way to characterize analytical sensitivity of cTn assays. STUDY: The raw data of 2252 cardiac troponin I (cTnI) tests done in duplicate with a 'sensitive' assay was extracted and used to calculate the cTnI levels in all, including those below the 'limit of detection' (LoD) that were censored. Duplicate results were used to determine analytical imprecision. RESULTS: We show that cTnI can be quantified in all samples including those with levels below the LoD and that the actual margins of error decrease as concentrations approach zero. CONCLUSIONS: The dichotomous classification of cTn assays into sensitive and highly-sensitive is theoretically flawed and characterizing analytical sensitivity as a continuous variable based on imprecision at 0 and the 99th percentile cut-off would be more appropriate.
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Ungerer et al. (2013) studied this question.
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