Heart Fatty Acid Binding Protein for the Diagnosis of Myocardial Ischemia and Infarction
Paul O Collinson1,2,3, Jennifer Hersey1, Rosalind Bray1
1Clinical Blood Sciences, St George's University Hospitals NHS Foundation Trust, London, UK.
Insights
This study found that heart fatty acid binding protein (HFABP) testing, despite good analytical performance, did not improve the diagnosis of chest pain patients for myocardial infarction or ischemia. HFABP may indicate myocardial infarction but not ischemia.
Area of Science:
- Clinical Chemistry
- Cardiovascular Diagnostics
- Biomarker Analysis
Background:
- Heart fatty acid binding protein (HFABP) is a potential biomarker for cardiac events.
- Assessing HFABP's utility in routine clinical diagnostics is crucial.
Purpose of the Study:
- To evaluate the analytical performance of an HFABP assay for clinical use.
- To determine HFABP's role in diagnosing myocardial ischemia and infarction.
Main Methods:
- Analytical performance (imprecision, LOD, linearity, stability) was assessed.
- Clinical diagnostic performance was evaluated in chest pain patients, comparing HFABP with cardiac troponin I (cTnI).
- Ischemia was assessed via pre- and post-angioplasty sampling.
Main Results:
- The HFABP assay's LOD and imprecision exceeded manufacturer specifications.
- Clinical diagnostic efficiency of HFABP was inferior to cTnI.
- Adding HFABP to cTnI improved sensitivity but significantly reduced specificity.
Conclusions:
- The HFABP test, despite excellent analytical characteristics, did not aid in diagnosing chest pain patients.
- HFABP appears to be a marker for myocardial infarction, not myocardial ischemia.
Objective:
To establish the analytical performance of a heart fatty acid binding protein (HFABP) method suitable for routine clinical use and examine its role for the diagnosis of myocardial ischemia and myocardial infarction.
Methods:
Analyses of HFABP were performed on an Advia 2400 (Siemens Healthcare Diagnostics). Imprecision, limit of detection (LOD), limit of blank (LOB), and linearity were assessed using standard methods. Stability was assessed at 4 °C, -20 °C, and with 3 repeated freeze-thaw cycles. Clinical diagnostic performance was assessed using chest pain in patients, with a final diagnosis according to the universal definition of myocardial infarction with cardiac troponin I (cTnI) measured on the Siemens Advia Centaur (cTnI Ultra method, 99th percentile 50 ng/L, 10% CV 30 ng/L). Ischemia was detected using sampling pre- and postangioplasty.
Results:
LOD and analytical imprecision exceeded the manufacturer's specification (LOD 1.128 μg/L, 20% CV 1.3 μg/L, 10% CV 2.75 μg/L). Clinical diagnostic efficiency was less than cTnI. Addition of HFABP to cTnI produced a modest increase in diagnostic sensitivity at a cost of significant loss of specificity.
Conclusions:
Although the test had excellent analytical performance, it did not contribute to the clinical diagnosis of patients with chest pain. HFABP appears to be a marker of myocardial infarction not myocardial ischemia.
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