Performance evaluation of the high sensitive troponin I assay on the Atellica IM analyser

IntroductionThe Fourth Universal Definition of Myocardial Infarction Global Taskforce recommends the use of high sensitive troponin (hs-Tn) assays in the diagnosis of acute myocardial infarction. We evaluated the analytical performance of the Atellica IM High-sensitivity Troponin I Assay (hs-TnI) (Siemens Healthcare Diagnostics Inc., Tarrytown, USA) and compared its performance to other hs-TnI assays (Siemens Advia Centaur, Dimension Vista, Dimension EXL, and Abbott Architect (Wiesbaden, Germany)) at one or more sites across Europe.Materials and methodsPrecision, detection limit, linearity, method comparison, and interference studies were performed according to Clinical and Laboratory Standards Institute protocols. Values in 40 healthy individuals were compared to the manufacturer’s cut-offs. Sample turnaround time (TAT) was examined.ResultsImprecision repeatability CVs were 1.1–4.7% and within-lab imprecision were 1.8–7.6% (10.0–25,000 ng/L). The limit of blank (LoB), detection (LoD), and quantitation (LoQ) aligned with the manufacturer’s values of 0.5 ng/L, 1.6 ng/L, and 2.5 ng/L, respectively. Passing-Bablok regression demonstrated good correlations between Atellica IM analyser with other systems; some minor deviations were observed. All results in healthy volunteers fell below the 99th percentile URL, and greater than 50% of each sex demonstrated values above the LoD. No interference was observed for biotin (≤ 1500 µg/L), but a slight bias at 5.0 g/L haemoglobin and 50 ng/L Tn was observed. TAT from was fast (mean time = 10.9 minutes) and reproducible (6%CV).ConclusionsReal-world analytical and TAT performance of the hs-TnI assay on the Atellica IM analyser make this assay fit for routine use in clinical laboratories.     

Postural control quantification in minimally and moderately impaired persons with multiple sclerosis: The reliability of a posturographic test and its relationships with functional ability

BackgroundPostural control has been associated with the functional impairment in persons with multiple sclerosis (pwMS). However, there is a need for reliable methods to assess postural control in early stages of the disease, when subtle changes can be difficult to detect. The aims of this study were to assess the absolute and relative reliability of a standing and a sitting posturographic protocol in minimally (Expanded Disability Status Scale ≤ 2) and moderately (2.5 ≤ Expanded Disability Status Scale ≤ 4) impaired pwMS, and to analyze relationships among postural control and functional mobility and gait performance.MethodsTo assess postural control in an upright stance, 14 minimally and 16 moderately impaired pwMS performed six 70 s trials in tandem stance, 3 with their weaker leg behind (TS_WL) and 3 with their stronger leg behind (TS_SL). Additionally, participants completed five 70 s trials using an unstable sitting protocol (US) to assess trunk stability. The mean radial errors of TS_WL, TS_SL, and US trials were calculated as postural control indexes. Furthermore, participants performed the Timed Up and Go test (TUG) and the Timed 25-foot Walk test (T25FW) to measure their functional mobility and gait speed, respectively. Reliability was evaluated using the intraclass correlation coefficient (ICC_3,1) and the standard error of measurement (SEM). Analyses of variances were carried out to assess between-group differences. Hedges’ g index (d_g) was used to estimate the effect size of differences. Pearson correlation analyses (r) were performed to examine the relationships among the postural control and the functional tests.ResultsPosturographic tests showed a high reliability in both minimally (0.87 ≤ ICC ≤ 0.92; 9.32% ≤ SEM ≤ 11.76%) and moderately (0.80 ≤ ICC ≤ 0.92; 10.33% ≤ SEM ≤ 15.33%) impaired pwMS. Similarly, T25FW and TUG displayed a high consistency in minimally (0.89 ≤ ICC ≤ 0.94; 3.43% ≤ SEM ≤ 5.17%) and moderately (0.85 ≤ ICC ≤ 0.93; 5.57% ≤ SEM ≤ 6.56%) impaired individuals. Minimally impaired pwMS showed a better performance on the TUG, T25FW, and TS_WL than moderately impaired individuals (p < 0.05; d_g ≥ 0.8). The TS_WL, TS_SL, and US variables correlated with TUG scores (0.419 ≤ r ≤ 0.604; p < 0.05), but TS_WL also correlated with T25FW scores (r = 0.53; p < 0.01). Furthermore, US scores correlated with both tandem stance parameters (TS_WL: r = 0.54, p < 0.01; TS_SL: r = 0.43, p < 0.05).ConclusionTandem and sitting posturographic tests provide reliable measures of postural control in pwMS, even in individuals with a homogeneous disease profile. Gait speed, functional mobility, and weaker leg status seem decisive in assessing the degree of physical activity limitation in pwMS. Finally, although trunk stability does not seem to be so affected by the course of the disease, it remains relevant for postural control and functional capacity.