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Cardiac markers: centralized or decentralized testing?
1Department of Laboratory Medicine, University Hospital, Padova, Italy. pad08821@pd.nettuno.it
Insights
New quantitative near-patient testing devices offer a viable alternative for diagnosing acute coronary syndrome, improving upon traditional methods and qualitative bedside tests for cardiac markers.
Area of Science:
- Clinical Chemistry
- Cardiovascular Diagnostics
- Point-of-Care Testing
Background:
- Traditional enzymatic assays for acute myocardial infarction are being replaced by more sensitive cardiac markers like troponins.
- The clinical utility of new cardiac markers raises questions about assay strategies, specimen handling, and turnaround times.
Purpose of the Study:
- To review the evolving landscape of cardiac marker testing for acute coronary syndrome.
- To evaluate near-patient testing (NPT) devices as an alternative to traditional laboratory methods.
- To discuss regulatory and quality management aspects of decentralized cardiac marker testing.
Main Methods:
- Review of current literature on cardiac marker assays and NPT devices.
- Analysis of the performance and limitations of qualitative and quantitative NPT devices.
- Discussion of regulatory and quality assurance considerations for NPT.
Main Results:
- Quantitative NPT devices show promise as a decentralized testing alternative.
- Qualitative bedside tests for cardiac markers have limitations impacting clinical usefulness.
- Emerging NPT technologies require careful consideration of performance and regulatory compliance.
Conclusions:
- Quantitative near-patient testing represents a significant advancement in diagnosing acute coronary syndrome.
- Careful selection and validation of NPT devices are crucial for clinical adoption.
- Decentralized testing strategies necessitate robust quality management and regulatory oversight.
Abstract:
Testing for the diagnosis of acute myocardial infarction and other diseases included in the spectrum of the "acute coronary syndrome" is rapidly changing from the traditional enzymatic assays to mass measurement of more specific and sensitive markers (cardiac troponins, CK-MB and myoglobin). Several questions have arisen since the introduction of these new markers into the clinical setting: the choice of strategies for optimizing the utilization of biochemical assays combining different (early and specific) markers, a rationale for sampling specimens and the identification of clinically useful turnaround times. In particular, for achieving the last goal, attention has been directed toward near-patient testing for cardiac markers in addition to, or as a replacement for, traditional diagnostic methodologies. While qualitative methods for measuring cardiac markers at the bedside have some limitations which compromise their clinical usefulness, new quantitative devices offer a real alternative to decentralized testing. Regulatory and quality management issues related to near-patient testing, as well as the performance of recently introduced devices for a decentralized measurement of cardiac markers are reviewed.