Abstract 1229 Poster Session IV, Tuesday, 5/4 (poster 354)

Background: Noninvasive devices for measurement of serum bilirubin concentration have been available for several years, but have not achieved widespread acceptance. This is mainly because measurements performed with available devices are affected by the infant's race, gestational age and birth weight which limits their use in heterogenous populations. The Chromatics Color Sciences Inc. TLc.BiliTest transcutaneous bilirubinometer is a hand-held computer-driven device for estimating the serum bilirubin from a newborn's skin color. The device consists of a xenon flash tube and light sensors that are connected to a portable computer. The algorithm incorporated into the device is designed to examine the luminosity of the skin and also incorporate the underlying color of normal skin and accounts for this in the baseline evaluation. In a study of 900 infants at 2 New York hospitals, there was a very good correlation between transcutaneous bilirubin and the total serum bilirubin concentrations (r=0.956). (Tayaba, et al. Pediatrics 1998;102:e28).

Methods: We used the TLc.BiliTest to estimate the serum bilirubin level in 171 infants (243 measurements) in whom serum bilirubin levels were measured on clinical indication. The number of infants studied at each hospital was: Beaumont 42, Parkland 38 and Elmhurst 91. Twenty-two (12.9%) of the infants weighed <2500 gm and 12 (7%) were <2000 gm. 25% of the babies studied were white, 50% Hispanic, 8% Asian, 8% black and 9% belonged to other racial groups.

Results: The total serum bilirubin levels ranged from 0.2-16.7 mg/dL and 31 (18%) had bilirubin levels ≥12 mg/dL. Linear regression analysis revealed a regression line with an intercept of .74, a slope of .91 and a correlation coefficient (r) of .93. 86.6% of the TLc.BiliTest measurements were within 2 mg/dL and 96.5% were within 3 mg/dL of the measured serum bilirubin concentration.

Conclusions: We conclude that the TLc.BiliTest provides a clinically useful estimate of the serum bilirubin level in a population of infants of diverse races and skin colors studied in 3 different institutions, where different laboratories were used to measure serum bilirubin concentrations. Studies are currently underway in China and South Africa and will provide additional information for the East Asian and African populations. The use of the TLc.BiliTest in newborn nurseries should decrease blood drawing and allow for convenient, noninvasive estimates of the serum bilirubin concentration both in the hospital and in outpatient settings.

Dr. Maisels is a medical consultant to Chromatics Color Sciences International Inc.