The BiliDx is a novel system for diagnosing jaundice. The device uniquely meets the Target Product Profile (TPP) developed as part of the NEST 360 initiative in that it allows blood-based testing at the bedside. This initiative is part of an emerging global consensus in the Every Newborn Action Plan that countries need functional WHO level-2 inpatient units to care for "small and sick newborns."
Why is diagnosis of jaundice so critical?
Though often referred to as 'yellow skin', jaundice may become severe without visible clinical symptoms. Often infants are sent home, only to develop more severe jaundice at home. Not only is a blood-based bilirubin test needed for initial diagnosis, but for ongoing monitoring of the effectiveness of phototherapy (blue light).
The problem in low-resource settings
In many hospitals and clinics, there is simply no reliable way to test infants for jaundice. In places where a laboratory is available, the turnaround time can be hours. The TPP for a bilirubinometer stated, "The ideal solution in a low-resource setting would be a reliable point-of-care test which can test serum bilirubin both before and during phototherapy treatment." If not treated, severe jaundice can eventually lead to irreversible neurological damage.
Why the BiliDx is Novel
At Maternova we research and then distribute innovative medical devices that have a strong clinical profile behind them. The BiliDx data from Malawi has been published in The Lancet and other peer-reviewed journals. The data showed that the BiliDx allowed a level of precision that is higher than the transcutaneous bilirubinometers (these rely upon light shining through the skin of the newborn).
The BiliDx system of a reader and lateral flow cassettes meets the Target Product Profile set forth by NEST 360. Now clinicians have the ability to immediately identify newborns with jaundice and then monitor treatment with phototherapy with a high level of accuracy.
The BiliDx provide lab-quality results from a whole blood heel stick in 10 minutes at the point of care. The device operates on a rechargeable, battery operated (standard USB charger 110 – 220V AC), lasting up to 24 hours. 600 tests can be run on a battery charge.
Now as a next step, we ask what could be done to lower the costs of the implementation of the E-MOTIVE bundle? The most obvious answer is to consider displacing the tens of thousands of disposable plastic drapes with a purpose-built reusable device.
Fortunately one of the obstetricians involved in the E-MOTIVE study, Dr. Justus Hofmeyr, had been innovating around this very issue, designing a tray with wells that could fit under a woman’s buttocks, collect and accurately measure the. blood. This tray, theMaternaWellTraywas conceived as a device that could be sterilized and reused, and is manufactured in South Africa by Umoya.
The Pumani bubbleCPAP was designed to meet this need for Malawi and is now widely available through Maternova. We had a few questions about post-research phases of the Pumani bubbleCPAP which we posed to Jocelyn Brown, inventor of the Pumani bubbleCPAP, and Molly McCabe, Director of Product Management.