Accuracy of transcutaneous bilirubin measured by the BiliCare device in late preterm and term neonates

OBJECTIVE: The objective of this study is to explore the accuracy and performance of a new transcutaneous bilirubinometer (TCB) for the screening of jaundice in late preterm and term infants. METHODS: A cross-sectional study was conducted. TCB measurements were performed using the BiliCare(TM) bilirubinometer. Paired TCB and serum bilirubin (SB) measurements were analysed. RESULTS: One hundred and fourteen paired samples were collected from 93 healthy late preterm and term infants. Bilirubin measurements were done at median (interquartile range) of 50.5 (34, 72) hours. The mean (SD) difference between the TCB and SB was 1.87 (1.98) mg/dL. A TCB cut-off level at 8.0 mg/dL provides a sensitivity of 97.3% with a negative predictive value (NPV) of 87.5% to detect a SB level of at least 8.0 mg/dL. For SB levels of at least 10.0 mg/dL, a TCB cut-off at 9.0 mg/dL shows a sensitivity of 97.5%; NPV 95.4%. For a SB level of at least 13.0 mg/dL, a TCB cut-off at 12 or 13 mg/dL had a sensitivity of 92.9% and NPV of 98.7%. CONCLUSION: The BiliCare(TM) demonstrated good performance with positive bias for the screening of jaundice in healthy late preterm or term infants. However, if adopted, proper cut-off levels should be chosen because of sub-optimal device precision.