Diagnostic Properties of a Portable Point-of-Care Method to Measure Bilirubin and a Transcutaneous Bilirubinometer.

BACKGROUND: Recently, the Bilistick®, a point-of-care instrument to measure bilirubin levels, has been developed. It is fast and cheaper than transcutaneous bilirubin (TCB)-measuring devices, but data on diagnostic properties are scarce. OBJECTIVE: This study aimed to compare the performance of the Bilistick® (BM-BS 1.0 - FW version 2.0.1) and the JM-105 bilirubinometer for measuring bilirubin. METHOD: This is a prospective study in infants born after ≥32 weeks' gestation, and/or a birth weight of ≥1,500 g, and a postnatal age ≤14 days in Surabaya, Indonesia. Bilirubin was measured with the Bilistick® System (BM-BS 1.0 - FW version 2.0.1), transcutaneously (TCB) with the JM-105 bilirubinometer, and in serum (TSB) with a routine laboratory technique. Mean differences and 95% limits of agreement (LOA) and correlations were calculated. RESULT: We enrolled 149 neonates and 126 had paired measurements of Bilistick® bilirubin, TCB, and TSB. Bilistick® failed in 16 (10.7%) infants. Mean Bilistick® bilirubin-TSB difference was -11 µmol/L (95% LOA: -101 to 79 µmol/L) and r = 0.738 (p < 0.001). Mean TCB-TSB difference was 26 µmol/L (95% LOA: -33 to 88) and r = 0.785 (p < 0.001). The sensitivity, specificity, PPV, and NPV for Bilistick® bilirubin for a TSB above treatment thresholds were 0.74, 0.84, 0.67, and 0.88, respectively, and for TCB 0.92, 0.64, 0.54, and 0.95, respectively. CONCLUSION: The Bilistick® System (BM-BS 1.0 - FW version 2.0.1) underestimates TSB, whereas TCB overestimates TSB in jaundiced Indonesian infants. Further improvement of Bilistick®'s diagnostic accuracy with less false-negative readings is essential to increase its use.

Kramer Score, an Evidence of Its Use in Accordance with Indonesian Hyperbilirubinemia Published Guideline.

Background: In some hospitals in low/middle-income countries, methods to determine the bilirubin level in newborn infants are unavailable and based on a clinical evaluation, namely a clinical score designed by Kramer. In this study, we evaluated if this score can be used to identify those infants that need phototherapy. Method: Infants admitted between November 2018 and June 2019 to three hospitals in Surabaya, Indonesia were included. The jaundice intensity was scored using the Kramer score. Blood was sampled for total serum bilirubin (TSB) measurement. The infants were categorized into Treatment Needed (TN) group when treatment with phototherapy was indicated and the No Treatment Needed (NTN) group when phototherapy was not indicated, based on the Indonesian Guideline for hyperbilirubinemia. Result: A total of 280 infants with a mean birth weight of 2744.6 ± 685.8 g and a gestational age of 37.3 ± 2.3 weeks were included. Twenty-seven of 113 (24%) infants with Kramer score 2 needed phototherapy, compared with 41 of 90 (46%) infants with score 3 and 20 of 28 (71%) of infants with score 4. The percentage of infants that needed phototherapy was higher with decreasing gestational age. Conclusion: The Kramer score is an invalid method to distinguish between those infants needing phototherapy and those infants where this treatment is not indicated.