Diagnostic Accuracy of a High-Sensitivity Cardiac Troponin Assay with a Single Serum Test in the Emergency Department

Richard Body; Raphael Twerenbold; Catrin Austin; Jasper Boeddinghaus; Malak Almashali; Thomas Nestelberger; Niall Morris; Patrick Badertscher; Garry McDowell; Karin Wildi; Phil Moss; Maria Rubini Gimenez; Heather Jarman; Nina Bigler; Rachael Einemann; Luca Koechlin; Ghazaleh Pourmahram; John Todd; Christian Mueller; Anthony Freemont

doi:10.1373/clinchem.2018.294272

Diagnostic Accuracy of a High-Sensitivity Cardiac Troponin Assay with a Single Serum Test in the Emergency Department

Richard Body, Raphael Twerenbold, Catrin Austin, Jasper Boeddinghaus, Malak Almashali, Thomas Nestelberger, Niall Morris, Patrick Badertscher, Garry McDowell, Karin Wildi, Phil Moss, Maria Rubini Gimenez, Heather Jarman, Nina Bigler, Rachael Einemann, Luca Koechlin, Ghazaleh Pourmahram, John Todd, Christian Mueller, Anthony Freemont

Research output: Contribution to journal › Article › peer-review

Abstract

OBJECTIVES: We sought to evaluate diagnostic accuracy of a high-sensitivity cardiac troponin I (hs-cTnI) assay for acute coronary syndromes (ACS) in the emergency department (ED). The assay has high precision at low concentrations and can detect cTnI in 96.8% of healthy individuals.

METHODS: In successive prospective multicenter studies ("testing" and "validation"), we included ED patients with suspected ACS. We drew blood for hs-cTnI [Singulex Clarity® cTnI; 99th percentile, 8.67 ng/L; limit of detection (LoD), 0.08 ng/L] on arrival. Patients also underwent hs-cTnT (Roche Elecsys) testing over ≥3 h. The primary outcome was an adjudicated diagnosis of ACS, defined as acute myocardial infarction (AMI; prevalent or incident), death, or revascularization within 30 days.

RESULTS: The testing and validation studies included 665 and 2470 patients, respectively, of which 94 (14.1%) and 565 (22.9%) had ACS. At a 1.5-ng/L cutoff, hs-cTnI had good sensitivity for AMI in both studies (98.7% and 98.1%, respectively) and would have "ruled out" 40.1% and 48.9% patients. However, sensitivity was lower for ACS (95.7% and 90.6%, respectively). At a 0.8-ng/L cutoff, sensitivity for ACS was higher (97.5% and 97.9%, ruling out 28.6% patients in each cohort). The hs-cTnT assay had similar performance at the LoD (24.6% ruled out; 97.2% sensitivity for ACS).

CONCLUSIONS: The hs-cTnI assay could immediately rule out AMI in 40% of patients and ACS in >25%, with similar accuracy to hs-cTnT at the LoD. Because of its high precision at low concentrations, this hs-cTnI assay has favorable characteristics for this clinical application.

Original language	English
Pages (from-to)	1006-1014
Number of pages	9
Journal	Clinical Chemistry
Volume	65
Issue number	8
Early online date	1 Aug 2019
DOIs	https://doi.org/10.1373/clinchem.2018.294272
Publication status	Published - Aug 2019

Keywords

Aged
Emergency Service, Hospital
Female
Humans
Male
Middle Aged
Myocardial Infarction/blood
Prospective Studies
Reproducibility of Results
Sensitivity and Specificity
Troponin I/blood
Troponin T/blood

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Manchester Molecular Pathology Innovation Centre (MMPathIC): Bridging the Gap Between Biomarker Discovery and Health and Wealth.
Freemont, A., Ananiadou, S., Barton, A., Black, G., Bruce, I., Buchan, I., Byers, R., Dive, C., Goodacre, R., Griffiths, C., Hoyland, J., Payne, K., Radford, J. & Whetton, A.
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Body, R., Twerenbold, R., Austin, C., Boeddinghaus, J., Almashali, M., Nestelberger, T., Morris, N., Badertscher, P., McDowell, G., Wildi, K., Moss, P., Rubini Gimenez, M., Jarman, H., Bigler, N., Einemann, R., Koechlin, L., Pourmahram, G., Todd, J., Mueller, C., & Freemont, A. (2019). Diagnostic Accuracy of a High-Sensitivity Cardiac Troponin Assay with a Single Serum Test in the Emergency Department. Clinical Chemistry, 65(8), 1006-1014. https://doi.org/10.1373/clinchem.2018.294272

@article{2e9056efc30b4aabb47e5d6d4d416118,

title = "Diagnostic Accuracy of a High-Sensitivity Cardiac Troponin Assay with a Single Serum Test in the Emergency Department",

abstract = "OBJECTIVES: We sought to evaluate diagnostic accuracy of a high-sensitivity cardiac troponin I (hs-cTnI) assay for acute coronary syndromes (ACS) in the emergency department (ED). The assay has high precision at low concentrations and can detect cTnI in 96.8% of healthy individuals.METHODS: In successive prospective multicenter studies ({"}testing{"} and {"}validation{"}), we included ED patients with suspected ACS. We drew blood for hs-cTnI [Singulex Clarity{\textregistered} cTnI; 99th percentile, 8.67 ng/L; limit of detection (LoD), 0.08 ng/L] on arrival. Patients also underwent hs-cTnT (Roche Elecsys) testing over ≥3 h. The primary outcome was an adjudicated diagnosis of ACS, defined as acute myocardial infarction (AMI; prevalent or incident), death, or revascularization within 30 days.RESULTS: The testing and validation studies included 665 and 2470 patients, respectively, of which 94 (14.1%) and 565 (22.9%) had ACS. At a 1.5-ng/L cutoff, hs-cTnI had good sensitivity for AMI in both studies (98.7% and 98.1%, respectively) and would have {"}ruled out{"} 40.1% and 48.9% patients. However, sensitivity was lower for ACS (95.7% and 90.6%, respectively). At a 0.8-ng/L cutoff, sensitivity for ACS was higher (97.5% and 97.9%, ruling out 28.6% patients in each cohort). The hs-cTnT assay had similar performance at the LoD (24.6% ruled out; 97.2% sensitivity for ACS).CONCLUSIONS: The hs-cTnI assay could immediately rule out AMI in 40% of patients and ACS in >25%, with similar accuracy to hs-cTnT at the LoD. Because of its high precision at low concentrations, this hs-cTnI assay has favorable characteristics for this clinical application.",

keywords = "Aged, Emergency Service, Hospital, Female, Humans, Male, Middle Aged, Myocardial Infarction/blood, Prospective Studies, Reproducibility of Results, Sensitivity and Specificity, Troponin I/blood, Troponin T/blood",

author = "Richard Body and Raphael Twerenbold and Catrin Austin and Jasper Boeddinghaus and Malak Almashali and Thomas Nestelberger and Niall Morris and Patrick Badertscher and Garry McDowell and Karin Wildi and Phil Moss and {Rubini Gimenez}, Maria and Heather Jarman and Nina Bigler and Rachael Einemann and Luca Koechlin and Ghazaleh Pourmahram and John Todd and Christian Mueller and Anthony Freemont",

note = "{\textcopyright} 2019 American Association for Clinical Chemistry.",

year = "2019",

month = aug,

doi = "10.1373/clinchem.2018.294272",

language = "English",

volume = "65",

pages = "1006--1014",

journal = "Clinical Chemistry",

issn = "0009-9147",

publisher = "Oxford University Press",

number = "8",

}

Body, R, Twerenbold, R, Austin, C, Boeddinghaus, J, Almashali, M, Nestelberger, T, Morris, N, Badertscher, P, McDowell, G, Wildi, K, Moss, P, Rubini Gimenez, M, Jarman, H, Bigler, N, Einemann, R, Koechlin, L, Pourmahram, G, Todd, J, Mueller, C & Freemont, A 2019, 'Diagnostic Accuracy of a High-Sensitivity Cardiac Troponin Assay with a Single Serum Test in the Emergency Department', Clinical Chemistry, vol. 65, no. 8, pp. 1006-1014. https://doi.org/10.1373/clinchem.2018.294272

TY - JOUR

T1 - Diagnostic Accuracy of a High-Sensitivity Cardiac Troponin Assay with a Single Serum Test in the Emergency Department

AU - Body, Richard

AU - Twerenbold, Raphael

AU - Austin, Catrin

AU - Boeddinghaus, Jasper

AU - Almashali, Malak

AU - Nestelberger, Thomas

AU - Morris, Niall

AU - Badertscher, Patrick

AU - McDowell, Garry

AU - Wildi, Karin

AU - Moss, Phil

AU - Rubini Gimenez, Maria

AU - Jarman, Heather

AU - Bigler, Nina

AU - Einemann, Rachael

AU - Koechlin, Luca

AU - Pourmahram, Ghazaleh

AU - Todd, John

AU - Mueller, Christian

AU - Freemont, Anthony

PY - 2019/8

Y1 - 2019/8

N2 - OBJECTIVES: We sought to evaluate diagnostic accuracy of a high-sensitivity cardiac troponin I (hs-cTnI) assay for acute coronary syndromes (ACS) in the emergency department (ED). The assay has high precision at low concentrations and can detect cTnI in 96.8% of healthy individuals.METHODS: In successive prospective multicenter studies ("testing" and "validation"), we included ED patients with suspected ACS. We drew blood for hs-cTnI [Singulex Clarity® cTnI; 99th percentile, 8.67 ng/L; limit of detection (LoD), 0.08 ng/L] on arrival. Patients also underwent hs-cTnT (Roche Elecsys) testing over ≥3 h. The primary outcome was an adjudicated diagnosis of ACS, defined as acute myocardial infarction (AMI; prevalent or incident), death, or revascularization within 30 days.RESULTS: The testing and validation studies included 665 and 2470 patients, respectively, of which 94 (14.1%) and 565 (22.9%) had ACS. At a 1.5-ng/L cutoff, hs-cTnI had good sensitivity for AMI in both studies (98.7% and 98.1%, respectively) and would have "ruled out" 40.1% and 48.9% patients. However, sensitivity was lower for ACS (95.7% and 90.6%, respectively). At a 0.8-ng/L cutoff, sensitivity for ACS was higher (97.5% and 97.9%, ruling out 28.6% patients in each cohort). The hs-cTnT assay had similar performance at the LoD (24.6% ruled out; 97.2% sensitivity for ACS).CONCLUSIONS: The hs-cTnI assay could immediately rule out AMI in 40% of patients and ACS in >25%, with similar accuracy to hs-cTnT at the LoD. Because of its high precision at low concentrations, this hs-cTnI assay has favorable characteristics for this clinical application.

AB - OBJECTIVES: We sought to evaluate diagnostic accuracy of a high-sensitivity cardiac troponin I (hs-cTnI) assay for acute coronary syndromes (ACS) in the emergency department (ED). The assay has high precision at low concentrations and can detect cTnI in 96.8% of healthy individuals.METHODS: In successive prospective multicenter studies ("testing" and "validation"), we included ED patients with suspected ACS. We drew blood for hs-cTnI [Singulex Clarity® cTnI; 99th percentile, 8.67 ng/L; limit of detection (LoD), 0.08 ng/L] on arrival. Patients also underwent hs-cTnT (Roche Elecsys) testing over ≥3 h. The primary outcome was an adjudicated diagnosis of ACS, defined as acute myocardial infarction (AMI; prevalent or incident), death, or revascularization within 30 days.RESULTS: The testing and validation studies included 665 and 2470 patients, respectively, of which 94 (14.1%) and 565 (22.9%) had ACS. At a 1.5-ng/L cutoff, hs-cTnI had good sensitivity for AMI in both studies (98.7% and 98.1%, respectively) and would have "ruled out" 40.1% and 48.9% patients. However, sensitivity was lower for ACS (95.7% and 90.6%, respectively). At a 0.8-ng/L cutoff, sensitivity for ACS was higher (97.5% and 97.9%, ruling out 28.6% patients in each cohort). The hs-cTnT assay had similar performance at the LoD (24.6% ruled out; 97.2% sensitivity for ACS).CONCLUSIONS: The hs-cTnI assay could immediately rule out AMI in 40% of patients and ACS in >25%, with similar accuracy to hs-cTnT at the LoD. Because of its high precision at low concentrations, this hs-cTnI assay has favorable characteristics for this clinical application.

KW - Aged

KW - Emergency Service, Hospital

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Myocardial Infarction/blood

KW - Prospective Studies

KW - Reproducibility of Results

KW - Sensitivity and Specificity

KW - Troponin I/blood

KW - Troponin T/blood

U2 - 10.1373/clinchem.2018.294272

DO - 10.1373/clinchem.2018.294272

M3 - Article

C2 - 31118187

VL - 65

SP - 1006

EP - 1014

JO - Clinical Chemistry

JF - Clinical Chemistry

SN - 0009-9147

IS - 8

ER -

Diagnostic Accuracy of a High-Sensitivity Cardiac Troponin Assay with a Single Serum Test in the Emergency Department

Abstract

Keywords

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Manchester Molecular Pathology Innovation Centre (MMPathIC): Bridging the Gap Between Biomarker Discovery and Health and Wealth.

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