Noninvasive Measurement of Total Serum Bilirubin in a Multiracial Predischarge Newborn Population to Assess the Risk of Severe Hyperbilirubinemia

Abstract

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...

Improved Transcutaneous Bilirubinometry: Comparison of SpectR X BiliCheck and Minolta Jaundice Meter JM-102 for Estimating Total Serum Bilirubin in a Normal Newborn Population

“…The BC meter uses multiple wavelengths to determine correction factors for the effect of melanin and hemoglobin on the bilirubin estimation. In the study of Bhutani et al, 5 there was also no effect of skin color as defined by race. Other studies have generally demonstrated that the JM meter readings are less accurate in babies with dark skin.…”

“…To illustrate this, we have analyzed our data according to the hour-specific serum bilirubin nomogram of Bhutani et al 8 The authors have demonstrated that infants with a serum bilirubin concentration above the 75th percentile on their nomogram ''may be considered to be at high risk for subsequent excessive hyperbilirubinemia,'' therefore requiring follow-up and that TCB may be used for the serum bilirubin estimation. 5 Their nomogram was based on universal serum bilirubin measurements at the time of metabolic screening. Approximately 50% of our population falls above the nomogram's 75th percentile because our screening was done only when there was clinical concern about the degree of visible jaundice.…”

“…4 Because of these requirements, we did not test this instrument. The BiliCheck system (SpectR X , Norcross, GA) (referred to as the BC meter) requires five replicate measurements at one site to give a bilirubin estimate 5 in milligrams per deciliter (or micromoles per liter), which is based upon reflectance data analyzed at multiple wavelengths. The Jaundice Meter JM-102 (Minolta/Hill-Rom Air-Shields, Hatboro, PA) (referred to as the JM meter) is based upon two-wavelength analysis and gives a reflectance unit which must be correlated to serum bilirubin level values at the local institution.…”

Measurement of Glucose and Protein in Urine Using Absorption Spectroscopy Under the Influence of Other Substances

“…[11] 적혈구나 빌리루빈의 경우에는 소변시료의 경우는 아니지 만 가시광선 대역의 흡수대역이 분명하여 이미 분광학을 이 용한 측정 연구가 소개되었다. [12,13] 또한 소변시료에 대한 흡 수분광학 분석에 대한 연구도 보고 되었다. [14,15] 에 대한 결과를 보여주고 있다.…”

Comparação entre a dosagem transcutânea e plasmática de bilirrubina

“…The light absorbed by the bilirubin is assessed after the portions affected by the quantity of collagen, melanin and hemoglobin have been duly accounted for. Initial studies with this type of equipment suggested that it would be possible to replace laboratory methods for measuring bilirubinemia by transcutaneous 3,4 More recent studies then cast doubt on the accuracy needed for this replacement, 5,6 suggesting that Pearson's correlation coefficient was calculated and, in order to assess agreement, a Bland-Altman graph was constructed.…”