Diagnostic Accuracy of a High-Sensitivity Cardiac Troponin Assay with a Single Serum Test in the Emergency Department
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Diagnostic Accuracy of a High-Sensitivity Cardiac Troponin Assay with a Single Serum Test in the Emergency Department. / Body, Richard; Twerenbold, Raphael; Austin, Catrin; Boeddinghaus, Jasper; Almashali, Malak; Nestelberger, Thomas; Morris, Niall; Badertscher, Patrick; McDowell, Garry; Wildi, Karin; Moss, Phil; Rubini Gimenez, Maria; Jarman, Heather; Bigler, Nina; Einemann, Rachael; Koechlin, Luca; Pourmahram, Ghazaleh; Todd, John; Mueller, Christian; Freemont, Anthony.
In: CLIN CHEM, Vol. 65, No. 8, 08.2019, p. 1006-1014.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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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
N1 - © 2019 American Association for Clinical Chemistry.
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 - SCORING: Journal article
C2 - 31118187
VL - 65
SP - 1006
EP - 1014
JO - CLIN CHEM
JF - CLIN CHEM
SN - 0009-9147
IS - 8
ER -