Condition
Neonatal hyperbilirubinemia (severe jaundice) is a common condition in newborns caused by elevated concentration of bilirubin, a neurotoxin.
Mechanism of Action
Analysis of blood serum, transcutaneous measurement, and clinical (visual inspection) are all possible methods for hyperbilirubinemia diagnosis. The gold standard method for bilirubin measurement is high performance liquid chromatography used on blood serum, but this method is only used in research laboratories. Medical laboratories can measure the bilirubin of blood by measuring light passed through a sample. Alternatively, these labs might be done chemically.
At the point of care, transcutaneous devices enable noninvasive measurement throughe skin. These devices measure skin reflectance, but they have limited sensitivity and specificity. Clinical diagnosis of jaundice is possible based on yellow pigmentation of the skin, however, even with a reference color strip, visual assessment is the least sensitive method.
Current use in High-Resource Settings
Blood gas analyzers or chemistry analyzers, such as the Beckman Coulter AU480 are most common in well-resourced settings. These devices have a throughput of hundreds of samples per hour and can perform dozens of other tests in addition to bilirubin concentration.
Application in Low-Resource Settings
Microcapillary photometric devices dedicated solely to bilirubin measurement, such as the Ginevri One Beam, offer relatively accurate bilirubin measurement and are compact and easy to use. Though the capital cost of these devices is much less than most blood gas or chemistry analyzers, cost is still a barrier to widespread adoption. Transcutaneous devices have a similar capital cost and offer two significant advantages for low-resource settings: the non-invasive measurements reduce the risk of infection and no disposables are needed. However, more development is needed to improve the accuracy of trancutaneous measurements. Visual inspection is also common, but suffers from low accuracy.