Background: To determine the diagnostic accuracy of a rapid heart-type fatty acid-binding protein (H-FABP) test in patients suspected of acute coronary syndrome (ACS) in primary care.
Methods: General practitioners included 298 patients suspected of ACS. In all patients, whether referred to hospital or not, ECG and cardiac biomarker testing was performed. ACS was determined in accordance with international guidelines. Multivariate analysis was used to determine the value of H-FABP in addition to clinical findings.
Results: Mean patient age was 66 years (SD 14), 52% was female and 66 patients (22%) were diagnosed with ACS. The H-FABP bedside test was performed within 24h (median 3.1, IQR 1.5 to 7.1) after symptom onset. The positive predictive value (PPV) of H-FABP was 65% (95% confidence interval (CI) 50-78). The negative predictive value (NPV) was 85% (95% CI 80-88). Sensitivity was 39% (29-51%) and specificity 94% (90-96%). Within 6h after symptom onset, the PPV was 72% (55-84) and the NPV was 83% (77-88), sensitivity 43% (31-57%) and specificity 94% (89-97%). Adding the H-FABP test to a diagnostic model for ACS led to an increase in the area under the receiver operating curve from 0.66 (95% CI 0.58-0.73) to 0.75 (95% CI 0.68-0.82).
Conclusion: The H-FABP rapid test provides modest additional diagnostic certainty in primary care. It cannot be used to safely exclude rule out ACS. The test can only be used safely in patients otherwise NOT referred to hospital by the GP, as an extra precaution not to miss ACS ('rule in').
Keywords: Acute coronary syndrome; Biomarker; Diagnosis; H-FABP; Primary care.
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