Neonatal hyperbilirubinemia occurs in more than 60% of term newborns and is characterized by a peak of serum bilirubin between the 3-5th day of life, returning to normal values in about 2 weeks.
In some cases, the level of bilirubin in the blood remain too high even more, 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, an irreversible pathology characterized by a severe disability due to neurological damage.
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. 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 new test is needed, taking a second sample from a blood vessel of the baby.
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
The Bilistick® System is an innovative diagnostic device, conceived as a Point Of Care test for measuring total bilirubin concentration in whole blood samples from newborns. It consists of Bilistick® Test Strip, where a small amount of blood is loaded, and Bilistick® Reader that analyzes the sample and shows the result.
Thanks to the easy method, the small size and the use of a battery powered reader, the Bilistick® System 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 hospital, such as during home follow up or in physician offices.
Bilistick® System Benefits
Portable and usable everywhere,
after a short training
requiring only one
tiny blood drop
No need of reagents,
(less than 100 sec.)
Test results comparable to
Measure of blood samples
with hematocrit (HCT)
ranging from 25% to 70%
Applicable to newborn
of all ethnicities
and all over the world
|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|