Implications of Adjustment of High-Sensitivity Cardiac Troponin T Assay

Kuster, Nils; Dupuy, Anne‐Marie; Monnier, Karine; Baptista, Grégory; Bargnoux, Anne-Sophie; Badiou, Stéphanie; Jeandel, Claude; Cristol, Jean‐Paul

doi:10.1373/clinchem.2012.197020

Cited by 11 publications

(8 citation statements)

References 4 publications

(7 reference statements)

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“…Our findings corroborate and extend previous pilot studies 11–13 and have important clinical implications beyond the specific hs-cTn assay examined. In our analysis, the hs-cTnT 2010–2012 low-end shift had no relevant clinical impact on the diagnosis of AMI when using conventional serial sampling, probably because the shift affected nearly exclusively values below the 99th percentile.…”

Section: Discussionsupporting

confidence: 90%

“…22,[28][29][30] Our findings thereby confirm and reinforce previous expert statements that manufacturers need to ensure that their internal quality assurance programmes would detect a similar problem in the future. 11,13 As the novel early hs-cTn-based rule-out strategies are increasingly used clinically, 28 a similar low-end shift if occurring now would be expected to result in relevant errors in the diagnosis of AMI and thereby definitely harm patients. It is important that both manufacturers and clinicians take their lessons from the hs-cTnT 2010-2012 low-end shift.…”

Section: Discussionmentioning

confidence: 99%

“…10,11 This 'low-end shift' may have affected the reliability of the measured cTn concentrations and thereby may have led to the misdiagnosis of AMI and adversely affected patient care. [10][11][12][13] In order to control retrospectively for the detected error, the manufacturer suggested as one approach a linear regression formula for recalculation of these hs-cTnT values obtained by affected assays. 10,11 The clinical implications of the 2010-2012 low-end shift in the diagnosis of AMI as well as the performance of the formula to recalculate hs-cTnT levels are largely unknown.…”

Section: Introductionmentioning

confidence: 99%

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Clinical impact of the 2010–2012 low-end shift of high-sensitivity cardiac troponin T

Wildi

Twerenbold

Jaeger

et al. 2016

European Heart Journal: Acute Cardiovascular Care

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Clinical impact of the 2010–2012 low-end shift of high-sensitivity cardiac troponin T

Wildi

Twerenbold

Jaeger

et al. 2016

European Heart Journal: Acute Cardiovascular Care

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“…In addition Roche internally assessed the effect of affected lots with readjustment mathematically in 1033 patients presenting to the ER. 28 The identical number of MIs was defined.…”

Section: Limitationsmentioning

confidence: 99%

A direct comparison of decision rules for early discharge of suspected acute coronary syndromes in the era of high sensitivity troponin

Chew

Frost

Mullen

et al. 2018

European Heart Journal: Acute Cardiovascular Care

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HEART ≤3 or LOD HSTnT strategy rules out short and medium term myocardial infarction with ≥99.5% certainty, and short-term MACE with >99% certainty, allowing for early discharge of 53.4% and 36.9% respectively of suspected acute coronary syndrome. Adoption of either strategy has the potential to greatly reduce Emergency Room pressures and minimise follow-up investigations. Very early presenters (<3 h), due to limited numbers, are excluded from these conclusions.

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“…The limit of blank and limit of detection have been determined to be 3 ng/L and 5 ng/L, respectively (4 ). None of the hs-cTnT measurements in this analysis were affected by the 2010 to 2012 calibration shift (20,21 ). Estimated glomerular filtration rate was calculated using the abbreviated Modification of Diet in Renal Disease formula (22 ).…”

Section: Investigational Hs-ctn Measurementsmentioning

confidence: 99%

Predicting Acute Myocardial Infarction with a Single Blood Draw

et al. 2019

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BACKGROUND We desired to determine cardiac troponin (cTn) concentrations necessary to achieve a positive predictive value (PPV) of ≥75% for acute myocardial infarction (AMI) to justify immediate admission of patients to a monitored unit and, in general, early coronary angiography. METHODS In a prospective multicenter diagnostic study enrolling patients presenting to the emergency department with symptoms suggestive of AMI, final diagnoses were adjudicated by 2 independent cardiologists based on clinical information including cardiac imaging. cTn concentrations were measured using 5 different sensitive and high-sensitivity cTn (hs-cTn) assays in a blinded fashion at presentation and serially thereafter. The diagnostic end point was PPV for rule-in of AMI of initial cTn concentrations alone and in combination with early changes. RESULTS Among 3828 patients, 616 (16%) had an AMI. At presentation, 7% to 14% of patients had cTnT/I concentrations associated with a PPV of ≥75%. Adding absolute or relative changes did not significantly further increase the PPV. PPVs increased from 46.5% (95% CI, 43.6–49.4) for hs-cTnT at presentation >14 ng/L to 78.9% (95% CI, 74.7–82.5) for >52 ng/L (P < 0.001), whereas PPVs in higher hs-cTnT strata remained largely unchanged [e.g., 82.4% (95% CI, 77.5–86.7) for >80 ng/L vs 83.9% (95% CI, 76.0–90.1) for >200 ng/L (P = 0.72)]. The addition of early changes in hs-cTnT further increased the PPV up to 60 ng/L, but not for higher concentrations. CONCLUSIONS Serial sampling does not seem necessary for predicting AMI and concurrent decision-making in about 10% of patients, as it only marginally increases the PPV for AMI and not in a statistically or clinically significant way. ClinicalTrials.gov Identifier NCT00470587.

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Implications of Adjustment of High-Sensitivity Cardiac Troponin T Assay

Cited by 11 publications

References 4 publications

Clinical impact of the 2010–2012 low-end shift of high-sensitivity cardiac troponin T

Clinical impact of the 2010–2012 low-end shift of high-sensitivity cardiac troponin T

A direct comparison of decision rules for early discharge of suspected acute coronary syndromes in the era of high sensitivity troponin

Predicting Acute Myocardial Infarction with a Single Blood Draw

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