Analytical performance of a sensitive assay for cardiac troponin I with loci™ technology

Arrebola, María Monsalud; Lillo, J.; Ríos, Mateo; Rodríguez, María Jesús; Dayaldasani, Anita; Yahyaoui, Raquel; Pérez, Víctor

doi:10.1016/j.clinbiochem.2010.04.073

Cited by 27 publications

(24 citation statements)

References 29 publications

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“…Only one independent study validated the sensitivity of the Dimension Vista cTnI Assay, and reported a LoB, LoD and 10 % CV cut-off of 11, 15, and 36 ng/L, respectively (42) .…”

Section: Dimension Vista Ctni Assay Siemens Healthcare Diagnosticsmentioning

confidence: 99%

A comprehensive review of upper reference limits reported for (high-)sensitivity cardiac troponin assays: the challenges that lie ahead

Am²,

Lh³

et al. 2012

Clinical Chemistry and Laboratory Medicine

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AbstractCardiac troponins (cTn) are the preferred markers for the diagnosis of acute myocardial infarction (AMI). The guidelines recommend the use of the 99th percentile upper reference concentration of a healthy population as the diagnostic cut-off for AMI. However, a broad range of upper reference limits is still employed, complicating the diagnosis of AMI. This overview is meant to assist laboratory specialists to define an appropriate cut-off value for the diagnosis of AMI. Therefore, we provide an overview of the analytical performance and upper reference limits of seven (high-)sensitivity cTn assays: Roche high-sensitivity cTnT and ADVIA Centaur, Stratus CS, Dimension Vista, Vitros ECi, Access and Architect cTnI assays. It is shown that none of the reference populations completely met the guidelines, including those in package inserts. Forty percent of the studies collected less than the advised minimum of 300 subjects. Many studies (50%) did not report their inclusion criteria, while lower 99th percentile limits were observed when more stringent selection criteria were applied. Higher troponin cut-offs were found in men and elderly subjects, suggesting sex- and age-specific cut-offs would be considered. Therefore, there is still need for a large, rigorously screened reference population to more accurately establish cTn upper reference limits.

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“…Only one independent study validated the sensitivity of the Dimension Vista cTnI Assay, and reported a LoB, LoD and 10 % CV cut-off of 11, 15, and 36 ng/L, respectively (42) .…”

Section: Dimension Vista Ctni Assay Siemens Healthcare Diagnosticsmentioning

confidence: 99%

A comprehensive review of upper reference limits reported for (high-)sensitivity cardiac troponin assays: the challenges that lie ahead

Am²,

Lh³

et al. 2012

Clinical Chemistry and Laboratory Medicine

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“…Several studies have relied exclusively on questionnaires to define reference individuals. Assessments of known clinical variables are often limited to reporting only a history of cardiovascular disease (18,35 ) or may involve more extensive screening for multiple variables, including known morbidities and current medications (19 -20 ). Some studies have used highly selective screening methods to define the final reference population.…”

Section: Defining Normalitymentioning

confidence: 99%

The Global Need to Define Normality: The 99th Percentile Value of Cardiac Troponin

2014

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BACKGROUND:How to select a presumably normal population for the establishment of 99th percentile cutoffs for cardiac troponin assays has not been adequately addressed. Lack of attention to this question can result in misleading medical decision cutoffs.CONTENT: From our review of the peer-reviewed literature, including international recommendations, no uniform procedure is followed and no uniform guideline has been published by experts or regulatory agencies to guide researchers or manufacturers of cardiac troponin assays in their quest to define the health or "normality" of a reference population that is used to establish an accurate 99th percentile value. As we progress globally into the era of high-sensitivity cardiac troponin assays, we propose several suggested approaches to define presumably normal individuals by use of clinical and biomarker surrogates.

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“…Several commercially available immunoassays measure the concentration of troponin I and myoglobin in serum. Hemolysis effect on troponin and myoglobin assays have been also evaluated by many investigators but there are still discrepancies about the level of this interference [7,8].…”

Section: Introductıonmentioning

confidence: 99%

Effects of hemolysis on the assays of serum CK, CK-MB activities and CK-MB (MASS), troponin and myoglobin measurments

Özcan¹,

Karakas²,

Yücel³

2012

Turk J Bioch

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Aim: The aim of the study was to investigate the effects of in vitro hemolysis on serum creatine kinase and creatine kinase MB isoenzyme activities with creatine kinase MB mass, troponin I and myoglobin measurements. Materials and methods:We prepared serum pools having analyte concentrations at normal and pathological values. Hemolysate was added into serum pools to obtain aliquotes with final hemoglobin concentrations of 21, 10.5, 5.25, 2.625, 1.312, 0.656, 0.328, 0.164, 0.08 and 0.041 g/L. Creatine kinase (by N-acetylcysteine-activated IFCC method) and creatine kinase MB activities (by immunoinhibition method) were measured in these pools. Creatine kinase MB (mass), troponin I and myoglobin concentrations were measured by chemiluminescence method. Mean percent changes were calculated and graphed as interferographs. Results: It was found that the positive interference due to hemolysis began to exceed the limit of 10% at lower Hb concentration for CK-MB activity than CK activity. When reference change value were considered, the critical effect of hemolysis began at higher hemoglobin concentrations. Hemolysis did not affect creatine kinase MB mass, troponin and myoglobin measurements when the limit of 10% change was considered. Conclusions: CK-MB activity is affected more profoundly than CK activity by hemolysis.

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Analytical performance of a sensitive assay for cardiac troponin I with loci™ technology

Cited by 27 publications

References 29 publications

A comprehensive review of upper reference limits reported for (high-)sensitivity cardiac troponin assays: the challenges that lie ahead

A comprehensive review of upper reference limits reported for (high-)sensitivity cardiac troponin assays: the challenges that lie ahead

The Global Need to Define Normality: The 99th Percentile Value of Cardiac Troponin

Effects of hemolysis on the assays of serum CK, CK-MB activities and CK-MB (MASS), troponin and myoglobin measurments

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