Objective To determine the accuracy of heart-type fatty acid-binding protein (H-FABP) as a new and early cardiac biomarker in the early diagnosis of acute myocardial infarction (AMI). The introduction of early and safe biomarkers could lead to (a) a large reduction in unnecessary hospital referrals of patients suspected of, but not, having AMI and (b) an earlier start of treatment in patients with AMI.

Design Diagnostic meta-analysis.

Setting Hospital and pre-hospital.

Patients Consecutive patients suspected of having AMI.

Main outcome measures A summary estimate for sensitivity and specificity was calculated using the bivariate random-effects approach, and covariate analysis was used to examine sources of heterogeneity between studies.

Results A systematic search yielded 16 studies (3709 patients, prevalence of AMI 13–74%, male gender 49–84%, median age 64–76 years). The summary estimate was 84% (95% CI 76% to 90%) for sensitivity and 84% (95% CI 76% to 89%) for specificity. Covariate analyses revealed that the use of troponin in the reference standard for AMI (as opposed to creatine kinase or creatine kinase-myocardial band) had a significant impact on sensitivity.

Conclusion H-FABP does not fulfil the requirements needed for a safe and early diagnosis of AMI when used as a stand-alone test. Sound diagnostic studies examining the additional role of H-FABP combined with clinical findings and other diagnostic tests are needed to further clarify a potential future role for this cardiac biomarker.