Performance Evaluation and Subsequent Clinical Experience with the Abbott Automated Architect STAT Troponin-I Assay

Lam, Que; Black, Melvin B.; Youdell, Odette; Spilsbury, Heather J.; Schneider, Hans‐Gerhard

doi:10.1373/clinchem.2005.057216

Cited by 39 publications

(26 citation statements)

References 15 publications

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“…Because 99th percentile values have been shown to vary by specimen type, it is important to clearly identify what specimen type was used in the methods section of a report (10,14,19,25 ). For example, Tate et al studied the 99th percentile in both plasma and serum among several cardiac troponin assays, finding concordant values for the 2 specimen types across the majority of assays.…”

Section: Serum Plasma or Whole Blood Cardiac Troponinmentioning

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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Section: Serum Plasma or Whole Blood Cardiac Troponinmentioning

confidence: 99%

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

2014

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“…4 However, only recently an assay (Roche troponin T hs assay) has become available that can consistently measure troponin T in about 50 -80% of the normal population. Furthermore, this assay provides increased precision at the 99th percentile.…”

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confidence: 99%

“…2 The first generation of troponin assays were already superior to the old creatine kinase MB assays 3 and the second-generation troponin assays improved diagnostic sensitivity compared with the first generation. 4 However, only recently an assay (Roche troponin T hs assay) has become available that can consistently measure troponin T in about 50 -80% of the normal population. Furthermore, this assay provides increased precision at the 99th percentile.…”

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confidence: 99%

How low can we go: high-sensitivity troponin T in patients presenting with chest pain

Schneider

2011

Ann Clin Biochem

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For the last 10 -15 years, troponin measurement has played a central role in the diagnosis of acute myocardial infarction (AMI). This has been most recently confirmed in the universal definition of AMI published by the Joint ESC/ACCF/ AHA/WHF Task Force for the Redefinition of Myocardial Infarction in 2007. 1 This definition of AMI requires the detection of a rise and fall of a cardiac biomarker ( preferably troponin) above the 99th percentile of a reference population together with evidence of ischaemia (either as clinical symptoms, electrocardiogram changes or imaging evidence showing loss of viable myocardium). The emphasis on the 99th percentile as the cut-off point comes from evidence obtained using older assays where any measurable troponin increase was associated with worse outcomes.In population studies using the troponin T assay, less than 1% of the population had detectable troponin T concentrations, and these were associated with cardiac abnormalities.2 The first generation of troponin assays were already superior to the old creatine kinase MB assays 3 and the second-generation troponin assays improved diagnostic sensitivity compared with the first generation. 4 However, only recently an assay (Roche troponin T hs assay) has become available that can consistently measure troponin T in about 50 -80% of the normal population. Furthermore, this assay provides increased precision at the 99th percentile. 5,6 While 10% coefficient of variation (CV) was requested by the original working party at the 99th percentile, none of the troponin assays of the time could provide this. More recently we realized that a 10% CV at this concentration is probably not required and it might be reasonable to accept a functional sensitivity similar to the endocrine assays of about 20%. 7,8 So, what are the real advantages of newer, more sensitive assays for troponin, if not the improved precision at decision cut-off points? These new high-sensitivity assays give us the opportunity to further refine our diagnostic armamentarium and possibly to improve the diagnostic potential of the assay.Apart from the analytical performance of new assays, it is the clinical evaluation that becomes crucial in trying to judge whether these new assays are real advances. In this edition, two studies look at the performance of the new high-sensitivity troponin T assay in patients presenting with chest pain to a teaching hospital in New Zealand and being evaluated for AMI.9,10 These timely papers extend previous studies published in 2009. 11,12 The first article from Aldous et al.9 investigates the performance of the high-sensitivity troponin T assay for the early detection of AMI. The sample is fairly small (332 patients out of a total number of about 1500 patients presenting to the Emergency Department) and the incidence of AMI is very high (33%). The New Zealand study confirms earlier studies in a European patient population, 11 showing that the highsensitivity troponin T assay is equivalent to secondgeneration troponin I assays and superior...

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“…At the time of the fourthgeneration assay use, the cutoff for cTnI was 0.03 g/L (30 ng/L) for both males and females. This roughly corresponded to our 99th percentile at the time of evaluation and introduction of the assay in 2004 (9 ). At the time of changeover to the high-sensitivity assay in July 2013 sexspecific 99th percentiles were adopted with cutoffs of 16 ng/L and 26 ng/L for females and males respectively.…”

Section: Methodsmentioning

confidence: 87%

Impact of High-Sensitivity Troponin I Testing with Sex-Specific Cutoffs on the Diagnosis of Acute Myocardial Infarction

et al. 2016

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BACKGROUND: High-sensitivity cardiac troponin I (hscTnI) assays show sex-dependent differences in the 99th percentile of healthy populations, with concentrations in women approximately 50% lower. The adoption of sex-specific cutoffs seems appropriate, although it is not yet clear what effect these will have on acute myocardial infarction (AMI) diagnosis and management. METHODS:We conducted a retrospective pre-and postchangeover analysis of troponin I testing in the 6 months before and after moving from the contemporary Abbott Architect TnI assay (cTnI) to hs-cTnI at 2 tertiary centers in Australia and New Zealand. The cTnI cutoff was 30 ng/L for both sexes, whereas a female-specific cutoff of 16 ng/L was adopted upon changeover to hsTnI. RESULTS:Changeover from the cTnI assay to the hs-cTnI assay increased the number of female patients with increased troponin I concentrations at both sites (from 29.7% to 34.9% and from 22.4% to 30.8%; P Ͻ 0.001). There was no statistically significant change in the number of men with increased concentrations in the same time period (P ϭ 0.09). The increased percentage of women with increased troponin I was not associated with an increase in the number of women with AMI diagnoses at either center. Angiographic data available from 1 center showed no change in the percentage of angiograms performed in women. CONCLUSIONS:Although increasing the proportion of women with increased troponin I, adopting sex-specific cutoffs with the hs-cTnI assay did not lead to an increase in AMI diagnoses in females, or in the number of women undergoing angiography. © 2016 American Association for Clinical ChemistryCardiac troponins are the preferred biomarkers for the detection of myocardial injury, and a rise and/or fall above the 99th percentile is an integral part of the universal consensus definition for diagnosis of acute myocardial infarction (AMI) 8 (1 ). In recent years, technical improvements have led to the development of highsensitivity assays that are capable of measuring low concentrations of cardiac troponin with high precision. With such assays, we are now able to measure cardiac troponin in the serum of healthy individuals, including children, who have no evidence of cardiovascular disease (2-4 ). The advent of high-sensitivity assays has uncovered sexspecific differences in circulating cardiac troponin concentrations that were formerly unrecognized because previous assays could not measure cardiac troponin with sufficient precision at or below the 99th percentile. It is now clear that the 99th percentile is substantially lower in females than it is in males (2,(5)(6)(7). Accordingly, several laboratories have implemented sex-specific reference intervals for cTnI, although the clinical impact is as yet unclear.The revelation of sex-dependent differences in circulating cardiac troponin raises several questions regarding the interpretation of cardiac troponin in women, and its possible downstream clinical effects. These are particularly pertinent given the large body of evidence suggest...

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Performance Evaluation and Subsequent Clinical Experience with the Abbott Automated Architect STAT Troponin-I Assay

Cited by 39 publications

References 15 publications

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

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

How low can we go: high-sensitivity troponin T in patients presenting with chest pain

Impact of High-Sensitivity Troponin I Testing with Sex-Specific Cutoffs on the Diagnosis of Acute Myocardial Infarction

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