No increase in the incidence of cardiac troponin I concentration above the 99th percentile by Siemens Centaur high-sensitivity compared to the contemporary assay.


Journal

Clinical biochemistry
ISSN: 1873-2933
Titre abrégé: Clin Biochem
Pays: United States
ID NLM: 0133660

Informations de publication

Date de publication:
Mar 2021
Historique:
received: 24 07 2020
revised: 30 11 2020
accepted: 01 12 2020
pubmed: 10 12 2020
medline: 5 3 2021
entrez: 9 12 2020
Statut: ppublish

Résumé

This study aimed to compare the incidence of cardiac troponin I (cTnI) concentrations above the limit of quantification (LOQ) and the sex-specific 99th percentile upper reference limits (URLs) between the Ultra contemporary cTnI assay and the high-sensitivity (hs-cTnI) assay on Siemens Centaur in patients evaluated in the emergency department (ED) and inpatient at a U.S. urban academic hospital. A retrospective study was performed in an unselected patient cohort who presented to the hospital with symptoms suggestive of myocardial injury. All clinically ordered samples for cTnI assay (n = 1,056, LOQ 0.03 µg/L, URL 0.04 µg/L) were simultaneously tested on the hs-cTnI assay (LOQ 2.5 ng/L; URL 58 ng/L and 39 ng/L for male and female, respectively). The incidence of elevated cTnI above the 99th percentile URL in males measured by the hs-cTnI assay was significantly lower compared to the cTnI assay (31.4% vs. 38.7%, p = 0.016), whereas there was no difference in females (27.4% vs. 30.2%, p = 0.35) in all the patient samples. In ED patient samples (n = 718), the incidence of elevated cTnI above the sex-specific 99th percentile URL was not significantly different between the hs-cTnI and contemporary cTnI assays in either sex (male: hs-cTnI 16.6% vs. cTnI 21.5%, p = 0.13; female: hs-cTnI 19.6% vs. cTnI 21.1%, p = 0.66). The agreement between the two assays was 93.5% (kappa = 0.798). Results were confirmed in an independent patient cohort measured by the same instruments at another hospital. Our study suggests that implementation of the hs-cTnI assay would not lead to an increase in the proportion of elevated cTnI above the 99th percentile in the emergency department and other inpatient units.

Sections du résumé

BACKGROUND BACKGROUND
This study aimed to compare the incidence of cardiac troponin I (cTnI) concentrations above the limit of quantification (LOQ) and the sex-specific 99th percentile upper reference limits (URLs) between the Ultra contemporary cTnI assay and the high-sensitivity (hs-cTnI) assay on Siemens Centaur in patients evaluated in the emergency department (ED) and inpatient at a U.S. urban academic hospital.
METHODS METHODS
A retrospective study was performed in an unselected patient cohort who presented to the hospital with symptoms suggestive of myocardial injury. All clinically ordered samples for cTnI assay (n = 1,056, LOQ 0.03 µg/L, URL 0.04 µg/L) were simultaneously tested on the hs-cTnI assay (LOQ 2.5 ng/L; URL 58 ng/L and 39 ng/L for male and female, respectively).
RESULTS RESULTS
The incidence of elevated cTnI above the 99th percentile URL in males measured by the hs-cTnI assay was significantly lower compared to the cTnI assay (31.4% vs. 38.7%, p = 0.016), whereas there was no difference in females (27.4% vs. 30.2%, p = 0.35) in all the patient samples. In ED patient samples (n = 718), the incidence of elevated cTnI above the sex-specific 99th percentile URL was not significantly different between the hs-cTnI and contemporary cTnI assays in either sex (male: hs-cTnI 16.6% vs. cTnI 21.5%, p = 0.13; female: hs-cTnI 19.6% vs. cTnI 21.1%, p = 0.66). The agreement between the two assays was 93.5% (kappa = 0.798). Results were confirmed in an independent patient cohort measured by the same instruments at another hospital.
CONCLUSION CONCLUSIONS
Our study suggests that implementation of the hs-cTnI assay would not lead to an increase in the proportion of elevated cTnI above the 99th percentile in the emergency department and other inpatient units.

Identifiants

pubmed: 33296707
pii: S0009-9120(20)30905-X
doi: 10.1016/j.clinbiochem.2020.12.001
pii:
doi:

Substances chimiques

Biomarkers 0
Troponin I 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

77-80

Informations de copyright

Copyright © 2020 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Auteurs

He S Yang (HS)

Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, NY, USA; New York-Presbyterian Hospital, Weill Cornell Medicine, New York, NY, USA.

Amos Shemesh (A)

New York-Presbyterian Hospital, Weill Cornell Medicine, New York, NY, USA; Department of Emergency Medicine, Weill Cornell Medicine, New York, NY, USA.

Jieli Li (J)

Department of Pathology, The Ohio State University Wexner Medical Center, Columbus, OH, USA.

Tingting Xie (T)

Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, NY, USA.

Fred S Apple (FS)

Departments of Laboratory Medicine and Pathology, Hennepin Healthcare/Hennepin County Medical Center and University of Minnesota, Minneapolis, MN, USA.

JoAnna Williams (J)

Department of Pathology, The Ohio State University Wexner Medical Center, Columbus, OH, USA.

Zhen Zhao (Z)

Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, NY, USA; New York-Presbyterian Hospital, Weill Cornell Medicine, New York, NY, USA. Electronic address: zhz9010@med.cornell.edu.

Peter A D Steel (PAD)

New York-Presbyterian Hospital, Weill Cornell Medicine, New York, NY, USA; Department of Emergency Medicine, Weill Cornell Medicine, New York, NY, USA. Electronic address: pes9027@med.cornell.edu.

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Classifications MeSH