Laboratory diagnostics of myocardial infarction – troponins and beyond

Lackner, Karl J.

doi:10.1515/cclm-2012-0572

Cited by 28 publications

(19 citation statements)

References 31 publications

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“…Throughout the first decade of the 21st century, and in the following years, the in vitro diagnostics (IVD) industry has focused on development of novel and more analytically effective techniques for measuring cardiac troponins. This novel generation of methods has been conventionally defined as "high-sensitivity" (HS), on the background that the main analytical features, thus including limit of blank (LoB, i.e., the highest apparent troponin value attainable with replicates of samples containing no protein), limit of detection (LoD, i.e., the lowest troponin concentration that can be reliably distinguished from the LoB) [7], as well as the 99th percentile URL and the value with ≤ 10% imprecision, should be substantially lowered to allow earlier and more efficient diagnosis of ACS [8,9].…”

Section: Historical Backgroundmentioning

confidence: 99%

Do we really need high-sensitivity troponin immunoassays in the emergency department? Maybe not

Lippi

Cervellin

2014

Clinical Chemistry and Laboratory Medicine (CCLM)

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The diagnosis of acute coronary syndrome (ACS) has challenged the minds of cardiologists, emergency physicians and laboratorists for decades. A major breakthrough has, however, occurred at the dawn of the third millennium, with development, commercialization and introduction into clinical practice of troponin immunoassays. A novel generation of these methods, conventionally defined as "high-sensitivity" (HS), has more recently emerged. These latest generation assays are characterized by improved analytical sensitivity, which would theoretically allow earlier and more efficient diagnosis of ACS. Despite the considerable amount of information gathered over the past few years about the clinical use of conventional and HS immunoassays, several doubts persist and - according to our personal perspective - the evidence that the latest generation methods would represent a real breakthrough in management of patients in short-stay units such as the emergency department is still an unresolved issue. Beside the mystifying nomenclature that characterizes several commercial tests, recent evidence suggests that the diagnostic performance of some contemporary sensitive methods would equal those of HS immunoassays for early diagnosis, serial assessment and even prognostication of patients. Conversely, the better diagnostic specificity of conventional methods may represent an advantage for triaging patients in overcrowded emergency departments. There is hence a tangible threat that the measurement of troponin with HS methods would become more or less an "expensive cholesterol of the third millennium", and this risk must be carefully considered in a world of limited resources. So, our answer to the question if we do really need HS troponin immunoassays in the emergency department is "maybe not".

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Section: Historical Backgroundmentioning

confidence: 99%

Do we really need high-sensitivity troponin immunoassays in the emergency department? Maybe not

Lippi

Cervellin

2014

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…While there was some evidence that some markers, e.g., copeptin and H-FABP improved early diagnosis and in particular early rule-out in the chest pain unit when combined with the traditional cTn assays, data with the novel hs-cTn assays are less clear [21]. Several studies show that copeptin can increase the sensitivity of laboratory testing on admission and therefore may permit very early rule-out.…”

Section: This Issue Of Clinical Chemistry and Laboratory Medicinementioning

confidence: 99%

High-sensitivity assays for cardiac troponins

Lackner

2015

Clinical Chemistry and Laboratory Medicine (CCLM)

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(CCLM) devotes a large section to the cardiac troponins (cTn) and in particular to the impact of the novel high sensitivity (hs) assays on clinical practice. Furthermore, several articles deal with known or novel pitfalls of hs-cTn in clinical diagnostics.While there is no doubt that the hs-cTn assays constitute a significant analytical step forward, they obviously introduced a momentum of uncertainty for many clinicians. Perhaps this is common to all innovations which force people to leave their well known firm ground. In the case of hs-Tn the major changes relate to the rule-in and rule-out criteria of myocardial infarction. Already the first studies have provided robust data that early rule-out can be substantially improved and the ESC has adapted their guidelines accordingly [1][2][3]. However, many clinicians feel that rule-in has become more complicated not to say confusing. Since many of the traditional cTn assays had cut-offs far beyond the 99th percentile due to their relatively high limit of quantitation (LoQ) [4], the positive predictive value of an abnormal test result was high. In fact, it is important to keep in mind that the upper reference limit (URL) of most assays was not the 99th percentile but a significantly higher plasma concentration of cTn [4]. The novel hs-cTn assays provide reliable results between their 99th percentile and the cut-off of their predecessor tests [5]. This opens up a gray zone which was neglected in the past. Interpretation and clinical consequences derived from hs-cTn results in this gray zone are currently debated. For some but not all assays we have thorough data about positive and negative predictive values depending on individual patient characteristics and timing of cTn plasma concentrations [6]. Another issue that is profoundly influenced by the hs-cTn assays is the analysis of changes in cTn plasma concentrations over time and their diagnostic potential [7]. Many traditional cTn assays were not able to provide reliable time courses close to the 99th percentile. Therefore, the use of Δ-cTn generated with these assays was very limited. With the novel hs-cTn assays it is possible to reliably determine Δ-cTn even below the 99th percentile. However, the meaning of such changes is not clear and we will need more data from dedicated studies to interpret them [8][9][10].In order to better appreciate these problems, it is helpful to remember the reasons for the new definition of myocardial infarction introduced in the year 2000 [11]. In the past we tended to differentiate between stable angina, unstable angina, and myocardial infarction. In the 1990s it became clear that patients with unstable angina with elevated cTn concentration had the same risk of adverse outcomes as patients with what was then considered myocardial infarction, while patients without cTn elevations had a much better prognosis [12]. Interestingly, this subgroup of unstable angina patients also benefited from the same interventions as patients with myocardial infarction [13]. This observation finally l...

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“…There are numerous papers showing that the combination of traditional cTn assays with other tests detecting cardiac damage improves predictive power. For the novel hs-cTn assays this improvement is either marginal or nonexistent so that the combination of several tests should no longer be considered [11].…”

Section: Future Benefits To Be Expectedmentioning

confidence: 99%

Do we really need high-sensitive troponin immunoassays in the emergency department? Definitely, yes!

Lackner

2014

Clinical Chemistry and Laboratory Medicine (CCLM)

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Cardiac troponins have changed our understanding of myocardial infarction profoundly during the past 20 years. In fact release of cardiac troponin into the blood has become part of the definition of myocardial infarction. Diagnostics and treatment have taken these new insights into account. The novel high-sensitive assays for cardiac troponins that are available recently clearly constitute a significant further improvement of analytical performance. In addition, the still incomplete clinical data available indicate that these assays will also further improve patient care in many ways. In summary, cardiac troponins are a great example of the potential impact of analytical performance of diagnostic tests on patient care and patient outcome.

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Laboratory diagnostics of myocardial infarction – troponins and beyond

Cited by 28 publications

References 31 publications

Do we really need high-sensitivity troponin immunoassays in the emergency department? Maybe not

Do we really need high-sensitivity troponin immunoassays in the emergency department? Maybe not

High-sensitivity assays for cardiac troponins

Do we really need high-sensitive troponin immunoassays in the emergency department? Definitely, yes!

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