Newborn Screening

A Transcutaneous Jaundice Detector (TcB meter) is a Class II medical device that non-invasively estimates serum bilirubin levels in newborns using reflectance spectrophotometry or multi-wavelength optical analysis, providing rapid (1-5 seconds), painless screening for neonatal hyperbilirubinemia. Handheld, battery-operated device measures yellow coloration of subcutaneous tissue at the forehead or sternum, displaying results in mg/dL or µmol/L. Features include digital display, data storage (100-1,000 readings), USB/Bluetooth connectivity, and disposable probe covers for infection control. Correlation with serum bilirubin typically R² >0.9. Primary clinical applications include universal newborn screening before hospital discharge (AAP guidelines), monitoring bilirubin trends in at-risk infants, assessing phototherapy efficacy, and post-discharge follow-up in community settings. Critical safety considerations include mandatory confirmatory serum testing for abnormal values, daily calibration verification, use of disposable probe covers to prevent cross-contamination, avoidance of measurement on phototherapy-exposed skin, and proper technique (site selection, gentle pressure, averaging multiple readings). Essential screening tool in newborn nurseries, NICUs, and community healthcare settings for preventing kernicterus through early detection and management of neonatal jaundice.