Comparing the accuracy of NEORUBIN NEO-2020 jaundice meter, Dräger JM103 jaundice meter and conventional blood testing for estimating total serum bilirubin in infants with jaundice in Malaysia

Abstract

Objective: To assess the accuracy of NEORUBIN® NEO-2020, a transcutaneous bilirubinometer in the clinical evaluation of bilirubin levels, versus a competitor device (Dräger JM103) and conventional blood testing (gold standard comparator) in infants diagnosed with jaundice in Malaysia. Study design: Infants who were brought to a public primary care clinic for follow-up due to suspected jaundice were screened using Dräger JM103 to assess the level of total serum bilirubin (TsB). Newborn infants who were at least 1 day old and born after 35–44 weeks of gestation/pregnancy with a TsB between 6–13.4 mg/dL/day (103–229 μmol/L/day) at screening were included in the study. Bilirubin levels of the infants were measured using NEO-2020, Dräger JM103, and conventional blood testing and the readings compared to validate NEO-2020’s accuracy, robustness, and reliability in clinical settings against the competitor device and conventional blood testing. Results: Compared to Dräger JM103, NEO-2020 showed a sensitivity of 99.4% (95% CI 96.9, 100), specificity of 0% (as all subjects in the study had jaundice symptoms), positive predictive value of 96.7% (95% CI 96.9, 96.7), and negative predictive value of 0%. The NEO-2020 had a 96.2% (95% CI 92.3, 98.5) accuracy rate in clinically evaluating bilirubin levels. Conclusion(s): Serum bilirubin levels recorded by the non-invasive NEO-2020 bilirubinometer were comparable to the readings from Dräger JM103 and conventional blood testing. Further tweaking and tests may improve the accuracy of NEO-2020.