European multicenter analytical evaluation of the Abbott ARCHITECT STAT high sensitive troponin I immunoassay

Krintus, Magdalena; Koziński, Marek; Boudry, Pascal; Capell, Nuria Estañ; Köller, Ursula; Lackner, Karl J.; Lefèvre, Guillaume; Lennartz, Lieselotte; Lotz, Johannes; Herranz, Antonio Mora; Nybo, Mads; Plebani, Mario; Sandberg, Maria Boysen; Schratzberger, Wolfgang; Shih, Jessie; Skadberg, Øyvind; Chargui, Ahmed Taoufik; Zaninotto, Martina; Sypniewska, Grażyna

doi:10.1515/cclm-2014-0107

Cited by 75 publications

(101 citation statements)

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“…increase in apparently healthy adult subjects aged over 65 years [10,13]. This finding was confirmed in studies using the highly sensitive cTnI method [14,27]. The progressive increase of circulating cTnT levels in apparently healthy adult subjects over 65 years was confirmed in the same period, when the highly sensitive ECLIA method became commercially available [11,12,26,[35][36][37].…”

Section: Agementioning

confidence: 71%

“…the criteria for considering the reference population "healthy") [17,[25][26][27][28][29], but also on the analytical performances of cTn methods, as well as on the mathematical algorithms used for calculating the 99th URL [10,14,15,17,18,25,26].…”

Section: Criteria For Calculating 99th Url Valuesmentioning

confidence: 99%

“…10% CV) [NaN]. The Architect method can also detect cTnI levels that exceed LoD in more than 85% of healthy subjects including children and adolescents [14,15], as requested by some consensus documents [16][17][18]. These data, shown in Table 1 and Figure 1, clearly indicate that the Architect method has the analytical performance required for a true highly sensitive method for cTnI assay.…”

Section: Introductionmentioning

confidence: 98%

“…However, measurement of the 99th URL of cTnI and cTnT levels is a challenging analytical issue due to low biomarker concentrations present in healthy subjects [7][8][9]. Only after 2006 some manufacturers set-up the first new generation of cTnI and cTnT immunoassays with improved analytical sensitivity in accordance with the quality specifications indicated in international guidelines and consensus documents [4,[6][7][8][9][10][11][12][13][14][15][16]. Importantly, highly sensitive methods should also be able to measure troponin levels in the majority of healthy adults subjects (>50%), as suggested in some consensus documents [16][17][18].…”

Section: Introductionmentioning

confidence: 99%

“…In one case, for example the manufacturer reports that the limit of blank (LoB) and limit of detection (LoD) for the highly sensitive cTnT method are 2. (Table 1) [14,15].…”

Section: Introductionmentioning

confidence: 99%

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The 99th percentile of reference population for cTnI and cTnT assay: methodology, pathophysiology and clinical implications

Clerico

Zaninotto

Ripoli

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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According to recent international guidelines, including the 2012 Third Universal Definiton of Myocardial Infarction by the Joint ESC/ACCF/AHA/WHF Task Force, an increase in cardiac troponin (cTn) levels over the 99th percentile upper reference limit (99th URL) should be considered clinically relevant, this cut-off being measured with an imprecision ≤10 CV%. In theory 99th URL values strongly depend not only on demographic and physiological variables (i.e. criteria for considering the reference population "healthy"), but also on the analytical performance of cTn methods and mathematical algorithms used for the calculation. The aim of the present article was therefore to review the methodological and pathophysiological factors affecting the evaluation and calculation of the 99th URL for cTn assay. The critical analysis made showed that no uniform procedure is followed, and nor have experts or regulatory bodies provided uniform guidelines for researchers or cTn assays manufacturers as an aid in "their quest to define normality". In particular, little attention has been paid to the way in which a healthy reference population is to be selected, or the criteria for calculating the 99th URL value for cTn assays, thus highlighting the need for international recommendations not only for demographic and physiological variables criteria for defining a healthy reference population, but also for calculating mathematical algorithms for establishing/ calculating clinical decision values. An expert consensus group, comprising laboratory and clinical scientists, biomedical statisticians, industrial and regulatory representatives, should be responsible for drawing up these guidelines.

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Section: Agementioning

confidence: 71%

Section: Criteria For Calculating 99th Url Valuesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 98%

Section: Introductionmentioning

confidence: 99%

“…In one case, for example the manufacturer reports that the limit of blank (LoB) and limit of detection (LoD) for the highly sensitive cTnT method are 2. (Table 1) [14,15].…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

The 99th percentile of reference population for cTnI and cTnT assay: methodology, pathophysiology and clinical implications

Clerico

Zaninotto

Ripoli

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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High-Sensitivity vs Conventional Troponin Cutoffs for Risk Stratification in Patients With Acute Pulmonary Embolism

Bikdeli,

Muriel,

Rodríguez

et al. 2024

JAMA Cardiol

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ImportanceHigh-sensitivity troponin tests can detect even milder cardiac troponin elevations in plasma, beyond the threshold of conventional troponin tests. Whether detection of low-grade cardiac troponin elevation is associated with outcomes of patients with hemodynamically stable pulmonary embolism (PE) and helps with risk stratification is unknown.ObjectiveTo determine the association between high-sensitivity cardiac troponin I (hs-cTnI) compared with conventional cardiac troponin I (cTnI) and PE risk designations according to the European Society of Cardiology (ESC) 2019 classification scheme and clinical outcomes in patients with hemodynamically stable PE.Design, Setting, and ParticipantsThis is a post hoc analysis of data from the prospective Prognostic Value of Computed Tomography (PROTECT) multicenter cohort study enrolling patients from 12 hospital emergency departments in Spain. In this analysis, cTnI and hs-cTnI were compared with respect to ESC risk designation, and the association between troponin values and a complicated course after PE diagnosis was evaluated. Of 848 patients enrolled in PROTECT, 834 (98.3%) had hsTnI and cTnI values available and were included in the present analysis. Data were analyzed from May to December 2022.ExposuresTroponin blood testing with cTnI (threshold of &gt;0.05 ng/mL) vs hs-cTnI (threshold of &gt;0.029 ng/mL) assays at the time of PE diagnosis.Main OutcomesComplicated course, defined as hemodynamic collapse, recurrent PE, or all-cause death, within 30 days after PE.ResultsOf 834 patients (mean [SEM] age, 67.5 [0.6] years; 424 [50.8%] female), 139 (16.7%) had elevated cTnI and 264 (31.7%) elevated hs-TnI, respectively. During follow-up, 62 patients (7.4%; 95% CI, 5.7-9.4) had a complicated course. Analyzing troponin elevation as a binary variable, elevated cTnI (odds ratio [OR], 2.84; 95% CI, 1.62-4.98) but not hs-cTnI (OR, 1.12; 95% CI, 0.65-1.93) was associated with increased odds of a complicated course. Of 125 patients who had elevated hs-cTnI but normal cTnI, none (0; 95% CI, 0.0-2.9) developed a complicated course. Using the 2019 ESC risk stratification scheme, hs-TnI classified fewer patients as low risk compared with cTnI. Among 78 patients designated as ESC low risk when using cTnI but not with hsTnI, none (0; 95% CI, 0.0-4.6) had a complicated course.Conclusions and RelevanceIn this study of patients with hemodynamically stable PE, hs-cTnI identified modest elevations in cardiac troponin levels. However, the results did not provide additive clinical value compared with cTnI. These findings suggest that use of hs-cTnI may result in overestimation of the risk in patients with stable PE.

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Development of Nucleic‐Acid‐Based Electrochemical Biosensors for Clinical Applications

et al. 2022

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Nucleic acids are remarkable molecules. In addition to Watson-Crick base pairing, the different structural motifs of these molecules can bind non-nucleic acid targets or catalyze chemical reactions. Additionally, nucleic acids are easily modified with different molecules or functional groups. These properties make nucleic acids, particularly DNA, ideally suited for use in electrochemical biosensors, both as biorecognition elements and redox reporter probes. In this Minireview, we will review the historical evolution of nucleic acids as probes in electrochemical biosensors. We will then review the specific examples of nucleic-acid-based biosensors that have been evaluated for clinical use in the areas of infectious disease, cancer, or cardiovascular health.

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European multicenter analytical evaluation of the Abbott ARCHITECT STAT high sensitive troponin I immunoassay

Abstract: The new ARCHITECT STAT hs-TnI assay with improved analytical features meets the criteria of high sensitive Tn test and will be a valuable diagnostic tool.

Cited by 75 publications

References 10 publications

The 99th percentile of reference population for cTnI and cTnT assay: methodology, pathophysiology and clinical implications

The 99th percentile of reference population for cTnI and cTnT assay: methodology, pathophysiology and clinical implications

High-Sensitivity vs Conventional Troponin Cutoffs for Risk Stratification in Patients With Acute Pulmonary Embolism

Development of Nucleic‐Acid‐Based Electrochemical Biosensors for Clinical Applications

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