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. 2022 Jun 15;32(2):020709.
doi: 10.11613/BM.2022.020709.

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

Antonio Buño Soto  1 , Katell Peoc'h  2   3 , Tommaso Fasano  4 , Jorge Diaz-Garzon  1 , Bernardino González de la Presa  5 , Valerie Chicha-Cattoir  2 , Simone Canovi  4 , Maria Sanz de Pedro  1 , Nayra Rico  5 , Tiphaine Robert  3 , Efrem Bonelli  4 , Pilar Fernández Calle  1 , Aurea Mira  5 , Guillaume Lefevre  6 , Luigi Vecchia  4 , Jose Luis Bedini  5
Affiliations

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

Antonio Buño Soto et al. Biochem Med (Zagreb). .

Abstract

Introduction: The 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 methods: Precision, 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.

Results: Imprecision 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).

Conclusions: Real-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.

Keywords: analytical techniques and equipment; high-sensitive troponin I; immunoassay; performance evaluation.

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Conflict of interest statement

Potential conflict of interest ABS has received consulting or lecturing fees from Siemens Healthcare Diagnostics Inc., Beckman Coulter, Radiometer and research grants from Radiometer and Roche. KP or her employer (APHP) has received consulting or lecturing fees from France Fresenius, Kabi, Masimo, Octapharma, Werfen, Vifor, Abbott, Brahms, Diasorin, and benefited from research grants from MSD Avenir and Fujirebio. VC-C or her employer (APHP) has received fees from Siemens Healthcare Diagnostics Inc. The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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