[Multicenter evaluation of the diagnostic efficacy of jaundice color card for neonatal hyperbilirubinemia]

Area of Science:

• Neonatology
• Diagnostic Accuracy
• Medical Device Evaluation

Background:

• Neonatal jaundice is a common condition requiring accurate screening.
• Early detection and management of hyperbilirubinemia are crucial to prevent serious complications.
• The Jaundice color card (JCard) offers a potentially accessible screening tool.

Purpose of the Study:

• To assess the diagnostic efficacy and practicality of the Jaundice color card (JCard) for screening neonatal jaundice.
• To compare the performance of the JCard against transcutaneous bilirubin (TcB) and total serum bilirubin (TSB) measurements.

Main Methods:

• A multicenter prospective study involving 854 newborns was conducted following STARD guidelines.
• Jaundice color card (JCard) measurements were compared with transcutaneous bilirubin (TcB) and total serum bilirubin (TSB) levels.
• Statistical analyses included Pearson's correlation, Bland-Altman plots, and receiver operating characteristic (ROC) curve analysis.

Main Results:

• JCard and TcB showed good correlation and agreement with TSB.
• JCard demonstrated high sensitivity (0.93) and specificity (0.75) for TSB ≥205.2 μmol/L.
• Diagnostic efficacy of JCard decreased with increasing bilirubin levels, with AUCs lower than TcB for TSB ≥256.5 μmol/L.

Conclusions:

• The Jaundice color card (JCard) is effective for classifying bilirubin levels, particularly at lower ranges.
• JCard's diagnostic performance is equivalent to the JH20-1B device for TSB levels ≤205.2 μmol/L.
• A JCard score of 12 is recommended for parents to screen for severe hyperbilirubinemia (TSB ≥342.0 μmol/L).