ABSTRACT. Background. Jaundice in near-term and term newborns is a frequent diagnosis that may prompt hospital readmission in the first postnatal week. Hyperbilirubinemia, when excessive, can lead to potentially irreversible bilirubin-induced neurotoxicity. Predischarge risk assessment (at 24 -72 hours of age) for subsequent excessive hyperbilirubinemia is feasible by a laboratory-based assay of total serum bilirubin (TSB).Hypothesis. Noninvasive, transcutaneous, point-ofcare measurement of transcutaneous bilirubin (TcB) predischarge by multiwavelength spectral analysis, using a portable BiliCheck device (SpectRx Inc, Norcross, GA), is clinically equivalent to measurement of TSB in a diverse, multiracial term and near-term newborn population and predictive of subsequent hyperbilirubinemia.Methodology. We evaluated a hand-held device that uses multiwavelength spectral reflectance analysis to measure TcB (BiliCheck). The study population (490 term and near-term newborns) was racially diverse (59.1% white, 29.5% black, 3.46% Hispanic, 4.48% Asian, and 3.46% other) and was evaluated at 2 separate institutions using multiple (11) devices. The postnatal age ranged from 12 to 98 hours and the ranges of birth weights and gestational ages were 2000 to 5665 g and 35 to 42 weeks, respectively. All transcutaneous evaluations were performed contemporaneously and paired with a heelstick TSB measurement. All TSB assays were performed by high performance liquid chromatography, as well as by diazo dichlorophenyldiazonium tetrafluoroborate techniques.Results. TSB values ranged from .2 to 18.2 mg/dL (mean ؎ standard deviation: 7.65 ؎ 3.35 mg/dL). The overall correlation of TSB (by high performance liquid chromatography technique) to TcB (by BiliCheck devices) was linear and statistically significant (r ؍ .91; r 2 ؍ .83; TcB ؍ .84; TSB ؍ ؉.75; standard error of regression line ؍ 1.38; P < .001; n ؍ 490 infants; 1788 samples). Similar regression statistics were evident in subset populations categorized by race (white: r ؍ .91 [n ؍ 289 infants]; black: r ؍ .91 [n ؍ 145 infants]) as well as by gestation (term: r ؍ .91 [n ؍ 1625 samples]; near-term: r ؍ .89 [n ؍ 163 samples]). Intradevice precision was determined to be .59 mg/dL (2-3 measurements per infant with 1 device; n ؍ 210 infants; 510 samples in a separate subset). Interdevice evaluation of 11 devices determined the precision to be .68 mg/dL (2-4 devices used for measurements per patient).In 23 of 419 of the study population infants who were in the 24-to 72-hour age range, the predischarge TSB values designated them to be at high risk for subsequent excessive hyperbilirubinemia (above the 95th percentile track on the hour-specific bilirubin nomogram). For these infants, the paired BiliCheck TcB values were all above the 75th percentile track (negative predictive value ؍ 100%; positive predictive value ؍ 32.86%; sensitivity ؍ 100%; specificity ؍ 88.1%; likelihood ratio ؍ 8.43).Conclusions. Our data demonstrate the accuracy and reproducibil...