A Novel Whole Spectrum-Based Non-Invasive Screening Device for Neonatal Hyperbilirubinemia

Objective: Careful screening of bilirubin level in newborns is mandatory as per American Academy of Pediatrics (2004), to reduce incidents of kernicterus and acute bilirubin encephalopathy. Although, invasive capillary collection of blood and subsequent biochemical test is considered a gold standard for jaundice detection in neonates, transcutaneous bilirubin measurement using various non-invasive instruments is also used sporadically across the globe. The major aim of this study was to develop a non-invasive spectrometry-based technique for measurement of neonatal bilirubin level as an alternative of total serum bilirubin (TSB) test without limitations of other available bilirubinometers. Methods: The instrument comprises of a light source and a spectroscopic detector. A light beam from source incident on the neonatal nail plate through optical fibers. The retro reflected light is acquired using the detector. An indigenously developed software is used to acquire and analyze the optical signal and to calculate the bilirubin value. The instrument was calibrated and validated in reference to TSB on 1033 subjects. Major results: The result (
r
= 0.95 and
P
< 0.001) indicates a strong correlation between the bilirubin value obtained from our method and TSB. Time variant analysis of the subjects undergoing phototherapy provided a good correlation (
r
= 0.98). The repeatability test result shows the mean coefficient of variation is less than 5.0%. Conclusions: The indigenously developed non-invasive technique successfully detects the bilirubin level in newborns under various physiological conditions with high accuracy and precision.