H-FABP Brochure LT237 - 24 Pages

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Catalogue excerpts

Heart-type Fatty Acid-Binding Protein Biomarker of myocardial ischemia

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H-FABP: The Protein • Heart-type Fatty Acid Binding Protein (H-FABP) is an unbound, low molecular weight protein, located in the cytoplasm of cardiac myocytes.1 • The molecular weight is only 15kDa – smaller than Myoglobin (18kDa), Troponin I (22kDa), Troponin T (37kDa) and CK-MB (86kDa). • The function of H-FABP is in the intracellular uptake of long chain fatty acids in the myocardium. Early release of protein after MI Endothelial Cell Endothelial Cell H-FABP Troponin Cardiac Myocyte

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Release Kinetics H-FABP: Release Kinetics CK-MB Time after symptom onset • H-FABP is highly specific to the heart – approximately 15-20 times more specific than Myoglobin.2 • The normal serum/plasma value is also much lower, compared to Myoglobin.3 • Due to the low molecular weight & cytoplasmic location of H-FABP, it is released extremely quickly after an ischemic episode – detectable as early as 30 minutes afterwards.4,5 • Furthermore, the rapid return to baseline within 24 hours, offers significant potential utility in patients with suspected reinfarction, instead of CK-MB.6 Times (Hours after...

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Diagnostic Value in ACS • Combining H-FABP and cTnT…provided a significant improvement in “ sensitivity for patients presenting within 4 and 12 hours” 7 • “Using the combination approach consistently improved the NPV, negative likelihood ratio, and the risk ratio” 7 “Multi-marker measurement of H-FABP and cTnI is 20% more sensitive than Troponin alone” 8 H-FABP - A highly sensitive early ischemic marker H-FABP Initial cTnT 4-12h ≥12h Time from symptom onset McCann CT et al7

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H-FABP and Troponin - the optimum biomarker strategy Time from symptom onset McMahon CG et al8 • “In the early hours after chest pain onset (CPO), H-FABP offered superior diagnostic sensitivity for AMI than Troponin” 8 • The optimal combination of biomarkers across all timepoints was Troponin I and H-FABP 8 Elevated H-FABP is a significant predictor of death or MI up to 1 year15

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H-FABP and Troponin - the optimum biomarker strategy CK-MB, myoglobin, Tnl Body R et al9 • Even based on samples taken immediately after hospital admission (<24h after CPO), the combination of H-FABP & Troponin I was superior to the triple marker strategy across the measures of sensitivity, specificity, PPV & NPV. 9

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H-FABP and Troponin enables early MI rule out n=1128 • “The combination of H-FABP & TnI can be used effectively as a rule-out test to exclude AMI within 6 hours of pain onset 8 • H-FABP & TnI offers a NPV of 98% at 3-6 hours after symptom onset 8 • Measuring H-FABP with Tnl also appears to identify at-risk patients with ACS more effectively than a single TnI assay 8

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H-FABP Diagnostic value of H-FABP combined with hsTnT •In a recent study at two Emergency Departments in the UK, 1171 patients with suspected cardiac chest pain had single blood samples taken on presentation (0h) to assess the potential value of the combination of H-FABP hsTnT & ECG to reliably rule-out AMI based on a single sample on presentation.10 This protocol on presentation resulted in a sensitivity for AMI of 99.1%, and a NPV of 99.7% - and could have enabled AMI to be excluded in 48.8% of patients. Percentage of symtomatic patients excludable for AMI according to diagnostic protocol Manchester...

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Diagnostic Value compared with Novel ACS Biomarkers Diagnostic Value compared with Novel ACS Biomarkers H-FABP Copeptin • H-FABP has been shown to offer superior diagnostic performance for AMI compared to a range of novel ACS biomarkers (based on ROC analysis). This is based on measurement on admission to a chest pain unit, then at 3 and 6 hours later.4

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H-FABP - Presence equals increased risk Less risk • Elevated H-FABP is a significant predictor of death or MI up to 1 year 15 • H-FABP provides additional prognostic information, independent of Troponin T ECG and clinical examination 15

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Prognostic value in Troponin - Negative patients Prognostic value in Troponin - Negative patients • H-FABP allows identification of high risk patients across the full range of TnI concentrations16 • Negative test result for both TnI and H-FABP was associated with 0% mortality Raised concentrations of H-FABP are strongly predictive of mortality after ACS16 H-FABP predicts mortality after ACS Tnl+ / H-FABP+ Tnl+ / H-FABPTnl- / H-FABP- 0 0 Based on a single blood sample at 12-24 hrs after ACS system onset Time (Days after event)

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Prognostic value in Troponin - Negative patients Prognostic value in Troponin - Negative patients • H-FABP taken 12-24 hours after admission, can identify Troponin-negative ACS patients who are at long-term risk of death17 • H-FABP identifies a very high risk group of patients who warrant further investigation & possible intervention17 • onversely, some ACS patients undergo angiography based on a false positive Troponin level. The addition of H-FABP to C Troponin measurement could avoid unnecessary investigations caused by false positives17 H-FABP predicts mortality after ACS 60% High risk refer...

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Prognostic value in Troponin - Negative patients • Study excluded patients with STEMI 17 • This shows increasing risk in quartile 2, 3, and 4 as compared with quartile 1 with a very significantly increased event rate in patients with H-FABP concentrations above 6.48 ng/ml 17 • The long-term prognostic value of H-FABP in troponin-negative patients is independent of age and serum creatinine 17

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Value of a fully quantitative H-FABP assay Value of a fully quantitative H-FABP assay Increased H-FABP concentrations confers increased risk Time of death or MI (in months) Viswanathan K et al17 • atients with H-FABP concentrations >6.48µg/L had significantly increased risk P of adverse events17 • mong Troponin negative patients, the cut-off of 6.48µg/L identified patients A at very high risk of adverse outcomes independent of patient age and serum creatinine17 This demonstrates a clear need for a fully quanitative H-FAB

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