Neonatal hyperbilirubinemia (neonatal jaundice) occurs in more than 60% of term newborns and is characterized by a peak of bilirubin between the 3-5th day of life, returning to normal values in about 2 weeks.
In some cases, high levels of bilirubin in the blood remain too high even after those 2 weeks, leading to severe hyperbilirubinemia in about 10% of the jaundice infants.
If caught in time, the most common treatment is phototherapy, but if not the baby risks to develop Kernicterus, a chronic and irreversible pathology characterized by a severe motor, hearing and intellectual deficit.
This creates the need for a system able to control the levels of bilirubin during the first days after birth in a simple and quick way.
Such a common condition needs to be managed so that the discomfort for the patients and their family is reduced to the minimum. Nowadays jaundice is diagnosed on time almost always, but how do they do it?
A blood test is required to check the levels of bilirubin and decide whether phototherapy is needed or not. That can be hard on such a little body, not to mention the fact that the risk of haemolysis is very high and in that case a second puncture is needed.
Secondly, to perform the exam the patient needs to be in the hospital. Often that means that the whole family has to go back and forth from the hospital, which is not just unpleasant, but also expensive.
Thirdly, the family needs to wait for the results of the test in the hospital, sometimes for hours, in order to know the final decision of the doctor on the need for phototherapy. Not to mention that the family has to be taken care of in the meantime.
Finally, the costs for the hospital itself are very high to keep up with a system like the one just described and highly trained personnel is needed both to perform the blood test and analyse the results.
Our challenge was to develop a device that could overcome all these problems by being simple to use, and therefore require minimal training, quick, portable, and minimally invasive.
Our solution, effective and portable
Bilistick ® System is an innovative diagnostic device, conceived as a Point of Care system for measuring Total Bilirubin concentration in whole blood samples from newborns.
The system consists of a test strip, where a small amount of blood is loaded, and a reader that gives you the result.
Thanks to the simplicity of the method, the small size of the system and the use of a battery powered reader, Bilistick® does not require availability of highly qualified staff or equipped facilities for analysis, making diagnosis and monitoring of neonatal jaundice a simple practice even outside of hospital facilities, such as during home follow up or in physician offices.
Bilistick® System Benefits
Portable and usable
a short training
requiring only one
blood drop (25μl)
Does not need the use
of reagents and results
(less than 100 sec.)
Able to measure in
blood samples with PCV
ranging from 25%
to newborn babies
of all ethnicities
|It measures total serum bilirubin|
|It's applicable on babies of all ethnicities|
|It gives results in less than 2 minutes|
|It's minimally invasive|
|It can be performed at home (POC)|
|It requires minimal training|