Randox Laboratories Ltd, the international clinical diagnostics company,
has today announced the official worldwide launch of an automated laboratory
assay for Heart-type Fatty Acid Binding Protein (H-FABP), to be used in the
diagnosis and management of patients with suspected acute coronary syndrome
(ACS).
This new quantitative, automated assay, and the encouragingly positive
results of several recent trials, mean that H-FABP is now ready to be
implemented into routine clinical practice, in combination with Troponin.
H-FABP is a low-weight cytoplasmic protein (15kDa) that is involved in
the intracellular uptake and buffering of free fatty acids in the myocardium.
It has been shown to be a highly sensitive & specific biomarker of
myocardial ischemia, as it is released within 30 minutes of an ischemic episode
and is 20 times more cardiac specific than Myoglobin.
Recent trials have shown that H-FABP has highly significant & additive
diagnostic value, especially during the early hours following ACS symptom
onset. Such results are particularly valuable, as this has traditionally been a
"troponin-blind" period for hospital Emergency Departments, and many patients
are conservatively admitted for further observation, in many cases,
unnecessarily. The addition of H-FABP to an existing Troponin test offers the
potential to rule-out ACS in many patients as early as their time of
presentation to hospital.
These results have been shown to apply, even when one of the new
generation of "high sensitivity" Troponins (hsTn) is used. The results of one
recently completed study from the University of Manchester, UK, were presented
at the IFCC EuroMedLab conference in Berlin on May 17th 2011. These results
suggest that utilising a combination hsTnT, H-FABP and ECG on admission, could
act as a highly accurate rule-out test for AMI.
Lead author of the study, Dr Rick Body, explains "We know from existing
evidence that H-FABP and troponin have additive diagnostic value. In a
recent publication in Resuscitation, we showed that the combination of H-FABP
and troponin is more accurate for early diagnosis than troponin alone and more
accurate than other more established biomarker combinations".
Dr. Body continues, "Recent publications report the enhanced diagnostic
value of hs-troponin assays. However, it is becoming apparent that even a
normal hs-troponin level at presentation doesn't rule out acute myocardial
infarction (AMI) without serial sampling. This demonstrates that
there is still the clinical need for an early marker such as H-FABP. The
preliminary analyses presented at IFCC EuroMedLab suggest that the combination
of H-FABP and hs-troponin is extremely promising and we eagerly await the outcome
and publication of our final analyses".
Such new studies on the diagnostic value of H-FABP further build on the
extensive existing evidence base on its prognostic value. Two recent landmark
studies from a group based at Leeds General Infirmary, UK, and published in the
prestigious Journal of the American College of Cardiology (JACC), showed that
H-FABP offers independent and additive prognostic value across the full
spectrum of ACS patients, and is a significant predictor of mortality in both
Troponin positive & Troponin negative patients. The Troponin negative
patients are of particular importance, as this group are usually stratified as
low-risk and frequently may be discharged from hospital.
"Presently, where Troponin is used on its own and generates a negative
result, patients are frequently sent home," says Lead Investigator, Professor
Alistair Hall. "However, our study found that a significant number of these
people are subsequently found to be at high risk of having a heart attack over
the coming months, if they have not done so already. H-FABP can help to
identify these high risk patients." Recent
data from the group also shows that these results hold true even after 6 years
of follow-up and, again, even when a highly sensitive Troponin assay is used.
CEO of Randox Laboratories, Dr Peter Fitzgerald, believes the release of
this new laboratory-based assay represents a new era in the clinical use of
acute cardiac biomarkers. "This exciting new quantitative and fully automated
assay means that hospitals around the world can now utilise H-FABP, in
combination with Troponin, as part of their standard clinical protocol.
H-FABP, alongside Troponin, offers much improved potential for ACS rule-out on
presentation, better risk stratification across the ACS spectrum and
facilitates improved management of post-MI patients". He continues, "The
new Randox H-FABP assay is a simple & rapid test that can be performed on a
wide range of clinical chemistry analysers, without the need for specialist software,
training or equipment. We believe it represents a wonderful opportunity to
improve the management of patients with suspected ACS and enable a more
effective utilisation of healthcare resources".
For more
information, please contact
cardiology@randox.com
Further reading
1)
Body R,
McDowell G, Carley S, Wibberley C, Ferguson J, Mackway-Jones K. A FABP-ulous
'rule out' strategy? Heart fatty acid binding protein and troponin for rapid
exclusion of acute myocardial infarction. Resuscitation. 2011 Apr 2.
2)
Kilcullen
N, Viswanathan K, Das R, Morrell C, Farrin A, Barth JH, Hall AS; EMMACE-2
Investigators. Heart-type fatty acid-binding protein predicts long-term mortality
after acute coronary syndrome and identifies high-risk patients across the
range of troponin values. J. Am. Coll. Cardiol. 2007;50(21):2061-7.
3)
Viswanathan
K, Kilcullen N, Morrell C, Thistlethwaite SJ, Sivananthan MU, Hassan TB, Barth
JH, Hall AS. heart-type fatty-acid binding-protein (H-FABP) predicts long-term
mortality and re-infarction in consecutive patients with suspected acute
coronary syndrome who are troponin negative. J. Am. Coll. Cardiol. 2010;55(23):
2590-8
4)
Pearson
IR, Hall AS, Gale CP, Sivananthan MU, Viswanathan K, Kilcullen N, Barth JH, In
Acute Coronary Syndromes, Heart-type Fatty Acid Binding Protein is a More
Accurate Predictor of Long Term Prognosis than Troponin. Circulation.
2010;122:A11374