Diagnostic accuracy of single baseline measurement of Elecsys Troponin T high-sensitive assay for diagnosis of acute myocardial infarction in emergency department: systematic review and meta-analysisBMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h15 (Published 21 January 2015) Cite this as: BMJ 2015;350:h15
- Zhivko Zhelev, research fellow in diagnostics1,
- Christopher Hyde, professor of public health and clinical epidemiology1,
- Emily Youngman, specialty registrar in public health1,
- Morwenna Rogers, information specialist1,
- Simon Fleming, consultant in clinical biochemistry2,
- Toby Slade, consultant in emergency medicine3,
- Helen Coelho, research fellow in HTA1,
- Tracey Jones-Hughes, research fellow in HTA1,
- Vasilis Nikolaou, statistician1
- 1Institute of Health Research, University of Exeter Medical School, Exeter EX2 4SG, UK
- 2Clinical Chemistry, Royal Cornwall Hospital, Treliske, Truro TR1 3LQ, UK
- 3Emergency Department, Royal Cornwall Hospital, Truro TR1 3LJ, UK
- Correspondence to: Z Zhelev
- Accepted 10 December 2014
Objective To obtain summary estimates of the accuracy of a single baseline measurement of the Elecsys Troponin T high-sensitive assay (Roche Diagnostics) for the diagnosis of acute myocardial infarction in patients presenting to the emergency department.
Design Systematic review and meta-analysis of diagnostic test accuracy studies.
Data sources Medline, Embase, and other relevant electronic databases were searched for papers published between January 2006 and December 2013.
Study selection Studies were included if they evaluated the diagnostic accuracy of a single baseline measurement of Elecsys Troponin T high-sensitive assay for the diagnosis of acute myocardial infarction in patients presenting to the emergency department with suspected acute coronary syndrome.
Study appraisal and data synthesis The first author screened all titles and abstracts identified through the searches and selected all potentially relevant papers. The screening of the full texts, the data extraction, and the methodological quality assessment, using the adapted QUADAS-2 tool, were conducted independently by two reviewers with disagreements being resolved through discussion or arbitration. If appropriate, meta-analysis was conducted using the hierarchical bivariate model.
Results Twenty three studies reported the performance of the evaluated assay at presentation. The results for 14 ng/L and 3-5 ng/L cut-off values were pooled separately. At 14 ng/L (20 papers), the summary sensitivity was 89.5% (95% confidence interval 86.3% to 92.1%) and the summary specificity was 77.1% (68.7% to 83.7%). At 3-5 ng/L (six papers), the summary sensitivity was 97.4% (94.9% to 98.7%) and the summary specificity was 42.4% (31.2% to 54.5%). This means that if 21 of 100 consecutive patients have the target condition (21%, the median prevalence across the studies), 2 (95% confidence interval 2 to 3) of 21 patients with acute myocardial infarction will be missed (false negatives) if 14 ng/L is used as a cut-off value and 18 (13 to 25) of 79 patients without acute myocardial infarction will test positive (false positives). If the 3-5 ng/L cut-off value is used, <1 (0 to 1) patient with acute myocardial infarction will be missed and 46 (36 to 54) patients without acute myocardial infarction will test positive.
Conclusions The results indicate that a single baseline measurement of the Elecsys Troponin T high-sensitive assay could be used to rule out acute myocardial infarction if lower cut-off values such as 3 ng/L or 5 ng/L are used. However, this method should be part of a comprehensive triage strategy and may not be appropriate for patients who present less than three hours after symptom onset. Care must also be exercised because of the higher imprecision of the evaluated assay and the greater effect of lot-to-lot reagent variation at low troponin concentrations.
Systematic review registration PROSPERO registration number CRD42013003926.
We acknowledge the contribution of Yemisi Takwoingi from the University of Birmingham, who provided valuable advice on the statistical methods used in this study.
Contributors: ZZ, CH, SF, and TS drafted the protocol. MR developed the search strategy and did the electronic searches. ZZ, HC, TJ-H, and EY screened the titles and abstracts and selected studies for inclusion. ZZ and EY carried out the data extraction and methodological quality assessment. CH, SF, and TS provided advice and arbitration on the selection process, data extraction, and methodological quality assessment. ZZ and VN did the statistical analysis. ZZ wrote the original draft, and the other authors revised the draft critically for important intellectual content and approved the final version of the paper. ZZ and CH are the guarantors.
Funding: This research was funded by the South West Academic Health Science Network (AHSN) and the National Institute for Health Research (NIHR) Collaboration for Leadership for Applied Health Research and Care for the South West Peninsula. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health. The AHSN and the NIHR had no involvement in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the paper for publication.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: ZZ and CH received financial support from the NIHR Collaboration for Leadership in Applied Health Research and Care for the South West Peninsula; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: Not required.
Transparency declaration: The lead author (ZZ) affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
Data sharing: No additional data available.
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