Monash University researchers have developed a fast, cheap tape-paper sensor test to detect bilirubin in jaundiced newborns, which could be commercialised for point-of-care diagnosis of neonatal jaundice.
The joint development by Monash University’s Faculty of Engineering, the Monash Institute of Medical Engineering and Monash Health, aims to provide results in under 10 minutes at a cost of around 60 cents each.
The small volume of samples and reagents needed and a simple kit could mean babies in remote and regional areas, and under-resourced poorer countries, could have bilirubin levels easily monitored and life-changing treatment administered.
The device could also release the strain on hospital resources in major cities, including the pressure of bed shortages in hospitals.
“Home treatment of jaundice is currently limited by expensive phototherapy equipment (biliblanket), nursing visits for invasive moderate blood volume testing and delays in blood results being made available,” Monash Children’s @Home medical lead Dr Katrina Harris said.
The method uses tape-paper sensing and involves blood applied directly onto paper which separates plasma from whole blood and measuring bilirubin by a colorimetric diazotization method.
“The most promising aspect of the tape-paper sensing approach for neonatal blood sample measurement has been verified in comparison with the current hospital pathology laboratory method,” Monash Department of Chemical Engineering researcher Professor Wei Shen said.
“And it can be done in the family home, anywhere in the world, with almost instant results.”
A common condition impacting around 60 per cent of newborns, jaundice can cause brain damage if left untreated. A newborn’s bilirubin levels usually peak at two to four days of age, when often the baby is already brought home.
The tape-paper sensor test could eliminate the need for an expensive nurse home visit and traditional blood test, saving time on results.
“The current procedure, adopted by Monash Children’s Hospital, for monitoring neonates who have been discharged three days after birth is via home-visits by nurses collecting neonates’ blood samples and then conducting blood bilirubin assays in the hospital,” Harris said.
“This process is followed by doctors making treatment decisions and nurses re-visiting the infants to provide treatments. Such a delayed analysis and feedback process can prolong treatment and increases risk to jaundice babies.
“Left untreated, high levels of bilirubin may result in brain impairment. This simple, fast, accurate, low-cost and timely point-of-care analysis of total bilirubin provides an unmet need, especially in resource-limited areas.”
Using blood samples from jaundiced neonates between the ages of 1-15 days, supplied by Monash Children’s Hospital, the device was tested to screen the bilirubin levels whether below or above the threshold concentration, based on the colour intensity comparison.
Monash University’s tape-paper sensor generates uniform colour distribution on the paper by eliminating the “coffee stain” effect through two mechanisms.
“This improves the accuracy of colorimetric evaluation on paper-based analytical devices,” Monash Department of Chemical Engineering researcher Dr Weirui Tan said.
“Such methodology is helpful to doctors and parents in determining if further clinical treatment needs to be adopted.
“The ability to commercialise these tape-paper sensors means we can get this into the hands of hospitals and nurses so they can provide timely care and support to newborns and their families.”
For background information on the tape-paper sensor test, click here.
This work is funded by the Monash Institute of Medical Engineering (MIME) and SPARK Oceania, in close collaboration with the Monash Children’s Hospital.