Validation of a transcutaneous bilirubin meter in Mongolian neonates: comparison with total serum bilirubin

Abstract

BackgroundNeonatal hyperbilirubinemia, especially kernicterus, can be prevented by screening for neonatal jaundice. The transcutaneous bilirubin (TcB) meter is a non-invasive medical device for screening neonates. The study aimed to investigate the validity of a TcB meter in a resource-limited setting such as Mongolia.MethodsTerm and late preterm neonates from the National Center for Maternal and Child Health of Ulaanbaatar in Mongolia who met the inclusion criteria (gestational age ≥35 weeks, birth weight ≥2000 g, postnatal age ≤ 1 month) were enrolled in the study. We used a TcB meter, JM-103 to screen for neonatal jaundice. TcB measurements at the infant’s forehead and midsternum were performed within 3 h of obtaining samples for total serum bilirubin (TSB) measurement. We analyzed the correlation between TcB measurements and TSB measurements to validate the meter.ResultsA total of 47 term and six late preterm neonates were included in the study. TcB measured by the meter at both the forehead and the midsternum showed a strong correlation with TSB measured in the laboratory. The correlation equations were TSB = 1.409+0.8655 × TcB (R2=0.78871) at the forehead, and TSB = 0.7555+0.8974 × TcB (R2=0.78488) at the midsternum. Bland-Altman plots and the Bradley-Blackwood test showed no significant differences between the two methods at all measured ranges of bilirubin. The mean areas under the curves of TcB at the forehead and midsternum at three TSB levels (>10 mg/dL, >13 mg/dL, >15 mg/dL) of TcB were greater than 0.9, and all had high sensitivity and specificity.ConclusionsThis study established the validity of the JM-103 meter as a screening tool for neonatal jaundice in term and late preterm infants in Mongolia. Future studies are needed, including the establishment of a TcB hour-specific nomogram, for more effective clinical practice to prevent severe hyperbilirubinemia.

Screening for Hyperbilirubinemia in Japanese Very Low Birthweight Infants Using Transcutaneous Bilirubinometry

“…Linear regression analysis was used to determine the correlation between TcB at each body site and TB levels. 6 The regression equation and coefficient of determination (R 2 ) were calculated using the results between the TcB and TB values. In addition, R 2 were compared between 0 and 7 days of age and thereafter.…”

“…Bland-Altman plots (mean AE 2 SD) were used to determine the difference between TcB at each body site and TB levels. 6 TcB cut-off values for detecting TB levels $10 mg/dL for each body site were analyzed by receiver oper-ating characteristics (ROC) curve analyses. The sensitivity, specificity, and positive and negative predictive values (PPV and NPV) were calculated and determined for the TcB cut-off value and the best measurement site.…”

“…These measurements are clinically useful for identifying term or late preterm infants with hyperbilirubinemia because TcB values correlate with TB levels, except for in Black infants. [3][4][5][6] Previous studies in preterm or VLBW infants have shown that TcB significantly correlates with TB levels, with a slightly weaker correlation coefficient than in term infants. 7-13 However, TcB measurements are not routinely used for screening for hyperbilirubinemia in this vulnerable population throughout the world.…”

Evaluation of BiliCare™ transcutaneous bilirubin device in Japanese newborns

“…Due to the stabilization of light emission, the JM‐105 has reduced measurement variation compared with the JM‐103. Given that it is necessary to compress the body site being evaluated for TcB using the JM‐103 or 105, there has been concern regarding the deviation in measured values among the individuals doing the measuring and the measurement sites …”

“…Given that it is necessary to compress the body site being evaluated for TcB using the JM-103 or 105, there has been concern regarding the deviation in measured values among the individuals doing the measuring and the measurement sites. 5,6 Recently, a new device, the BiliCare TM system (Natus Medical, Pleasanton, CA, USA), has been developed, which measures TcB at the ear. The BiliCare uses a light-emitting diode (LED) lamp, which is different from the JM-103 and 105.…”