Horizon 2020 SME
H-FABP True Rapid Test

As a first application FABPulous has developed a rapid CE-marked test to aid in the diagnosis of acute myocardial infarction (AMI) in first line medical care.

The test integrates FABPulous’ innovative plasma separation technology (detailed in Technology Section) with proven high-quality lateral flow immunoassay detection, allowing for a time to result of 2-5 min. The simple and robust work flow allows for testing at the doctor’s office and at visits to the patients home as well.

Need for Better Exclusion of Acute Myocardial Infarction in Acute Chest Pain

In the developed world approximately 1-2% of the adult population annually seek medical attention  with complaints of chest pain [1]. In the US it is the second highest reason for admission to the emergency department (ED) [2]. As primary care physicians presently lack objective diagnostic tools to rule out an acute myocardial infarct (AMI) many patients are urgently referred to the ED by ambulance and undergo further diagnostic work-up with a 12-lead electrocardiogram and serial troponin tests during 6-9 hours. Only 10-13% of admitted patients with suspected AMI have a confirmed acute myocardial infarction [2].

On the other hand the first symptoms of an AMI may be very atypical, for instance in elderly diabetic women and thus without additional objective diagnostic tools can be easily missed. It has been reported that inappropriate discharge is associated with a 5-fold increase in mortality and morbidity [3]. Consequently improved diagnosis and triage of patients by primary care workers has the potential to greatly improve quality of care for these patients and reduce the social, logistical and financial burden associated with these frequent inappropriate referrals.

Heart type Fatty Acid Binding Protein (H-FABP)

H-FABP is a small protein abundantly present in myocardial cells. It functions in the intracellular uptake and transport of long-chain fatty acids. It is rapidly released into the circulation after myocardial cell damage, for example after hypoxia due to an AMI. The diagnostic potential for AMI has been described first by Prof. Glatz (the current CSO of FABPulous) in 1988 [4]. It is released earlier into the bloodstream than troponin and has a 20-fold higher specificity than myoglobin. In close collaboration with Roche, Glatz has produced a pair of high quality monoclonal antibodies as well as recombinant H-FABP protein, the key components of the ELISA they developed and that has been used in numerous clinical studies since. Many reports since have confirmed that H-FABP is a promising early marker of myocardial damage as seen in AMI. In addition it has been reported as a prognostic indicator of adverse cardiac events in patients with severe sepsis and septic shock and acute pulmonary embolism.

Graph-H-FABP-vs-Troponin

J.Glatz, data on file

 

McMahon [5] reported that H-FABP has a higher sensitivity than cardiac troponin I (cTnI) early after onset of symptoms of AMI. In 2012 Keller published a similar study comparing high sensitivity troponin (hsTnI), TnI and 12 other biomarkers including H-FABP. They reported that early after chest pain onset hsTnI had the highest sensitivity followed H-FABP and cTnI, respectively. However, hsTnI testing requires platforms that do not meet the needs or capabilities of primary care providers, such as general practitioners. Based on this notion, FABPulous set out to develop a high-quality H-FABP test in combination with the ultra-rapid plasma preparation device.

H-FABP True Rapid Test Performance

The H-FABP True Rapid Test has been optimized to allow first line physicians to rule out AMI in patients presenting with acute chest pain, 3 to 18 hours after onset of symptoms, with a negative predictive value (NPV) >97-98%, superior to cTnI, myoglobin and CK-MB and similar to hs-cTnI.

As such, the H-FABP True Rapid Test will improve the quality of care for these patients and reduce the logistic and financial burden for the health care system.

Workflow H-FABP True Rapid Test

The disposable device has been designed to deliver a consistent and reliable performance, using as few parts as possible, and an easy-to-understand set-up. Basically it involves only a few steps:

  1. Collect drop of blood obtained from a finger prick with collection device; the device contains a sponge designed to absorb a set volume of whole blood.2) Dock blood collection device onto cartridge
  2. Twist the blue part of the blood collection part such that it moves downward
  3. Read final test result within 2 to 5 minutes

Workflow-FS-TRT-EN1

For a detailed description of the test, the Instructions For Use can be downloaded here.

Instruction video

Frequently Asked Questions

Click here for a list of Frequently Asked Questions and clarification of the Symbols used on the packaging and instructions for use.

References

[1] Nilsson S, Scheike M, Engblom D et al.. Br J Gen Pract 2003; 53: 378-382

[2] Pope HJ, Aufderheide TP, Ruthazer R, et al,. NEJM 2000; 342(16):1163-70

[3] Collinson PO, Premachandram S, Hasehmi K. BMJ 2000;320:1702-5

[4] Glatz JFC, van Bilsen M, Paulussen RJA, et al. Biochem Biophys Acta 1988; 961:148-52

[5] McMahon CG, lamont JV, Curtin E, et al.. Am J Emerg Med. 2012 Feb;30(2):267-74