Performance evaluation of the high sensitive troponin I assay on the Atellica IM analyser
Croatian Society of Medical Biochemistry and Laboratory Medicine..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:32 |
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| Enthalten in: |
Biochemia medica - 32(2022), 2 vom: 15. Juni, Seite 020709 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Buño Soto, Antonio [VerfasserIn] |
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| Links: |
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| Themen: |
Analytical techniques and equipment |
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| Anmerkungen: |
Date Completed 11.07.2022 Date Revised 16.07.2022 published: Print Citation Status MEDLINE |
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| doi: |
10.11613/BM.2022.020709 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM343205513 |
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| 245 | 1 | 0 | |a Performance evaluation of the high sensitive troponin I assay on the Atellica IM analyser |
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| 500 | |a Date Revised 16.07.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Croatian Society of Medical Biochemistry and Laboratory Medicine. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a analytical techniques and equipment | |
| 650 | 4 | |a high-sensitive troponin I | |
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| 650 | 4 | |a performance evaluation | |
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| 700 | 1 | |a Peoc'h, Katell |e verfasserin |4 aut | |
| 700 | 1 | |a Fasano, Tommaso |e verfasserin |4 aut | |
| 700 | 1 | |a Diaz-Garzon, Jorge |e verfasserin |4 aut | |
| 700 | 1 | |a González de la Presa, Bernardino |e verfasserin |4 aut | |
| 700 | 1 | |a Chicha-Cattoir, Valerie |e verfasserin |4 aut | |
| 700 | 1 | |a Canovi, Simone |e verfasserin |4 aut | |
| 700 | 1 | |a de Pedro, Maria Sanz |e verfasserin |4 aut | |
| 700 | 1 | |a Rico, Nayra |e verfasserin |4 aut | |
| 700 | 1 | |a Robert, Tiphaine |e verfasserin |4 aut | |
| 700 | 1 | |a Bonelli, Efrem |e verfasserin |4 aut | |
| 700 | 1 | |a Calle, Pilar Fernández |e verfasserin |4 aut | |
| 700 | 1 | |a Mira, Aurea |e verfasserin |4 aut | |
| 700 | 1 | |a Lefevre, Guillaume |e verfasserin |4 aut | |
| 700 | 1 | |a Vecchia, Luigi |e verfasserin |4 aut | |
| 700 | 1 | |a Bedini, Jose Luis |e verfasserin |4 aut | |
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