Development and evaluation of a novel method “bilirubin color card” for screening of treatable jaundice in neonates: prospective comparative diagnostic study

Abstract Background Various methods of screening or diagnosis of severe hyperbilirubinemia like transcutaneous bilirubinometer and laboratory testing havemethodological or practical limitations. In this perspective, we designed and evaluated an invasive but simple screening Color Card method in rapid assessment of various levels of bilirubin categories. Objective This prospective comparative diagnostic study objectives were to create “Color Card” initially by yellow color shades that fall into 4 bilirubin categories, i.e. TSB up to 7 mg/dl, 7.1 to 12 mg/dl, 12.1 to 18 mg/dl and >18 mg/dl from the samples analyzed by diazo method, and to study its sensitivity and specificity for the diagnosis of moderate or severe hyperbilirubinemia in comparison to total serum bilirubin (TSB) by diazo method. Results Out of total 188 samples obtained, 134 were unique patients. The specificity, negative predictive value and accuracy of the color card for the observations made by observer 1 comparing with lab TSB were >95% for clinically important categories of <7 mg/dl and >18 mg/dl. The overall accuracy of color card in measuring various TSB ranges varied from 75% to 96.8%. The agreement between two observers was 85.6% (Cohen’s kappa co-efficient: 0.61, p-value: .0001) overall and was 92.3%, 86%, 84%, 81.2% for each of the four bilirubin categories in ascending order. Conclusion Bilirubin color card has good accuracy and may be very useful in the low resource settings, especially in the first referral units and community settings, where laboratory TSB estimation is not available easily. However, it requires centrifugation and easier methods of centrifugation will make this method simpler.