Objective To evaluate the role of a color jaundice card (6 colors) as a possible screening tool for detecting neonatal hyperbilirubinemia.Methods During February 1,2016 and May 31,2017,neonates were enrolled in the study,with gestational age ≥35 weeks,birth weight ≥2 000 g,postnatal age 3-28 days,who were the outpatients or inpatients of the 9th People's Hospital of Wuxi Affiliated to Soochow University and the People's Hospital of Anyang.In a well-lighted room,the card measurements were performed at the infants' forehead,the cheek and the sternum.The skin was pressed with a finger for 2 seconds and left quickly,and then the card was used to compare with the exposed yellow skin.Within 2 hours after jaundice card measurement,blood was obtained by venipuncture and total serum bilirubin (TSB) levels were measured.The sensitivity,specificity,positive predictive value (PPV),negative predictive value (NPV),positive likelihood ratio (PLR) and negative likelihood ratio (NLR) were calculated at each measurement sites.Results One hundred and thirty-two neonates were enrolled,of whom 68 cases (51.5％) were male and 64 cases(48.5％) were female and 18 cases (13.6％) were preterm and 114 cases (86.4％) were term neonates.Among all neonates,TSB was ＜5.00 mg/dL(1 mg/dL =17.1 μmol/L) in 21 cases (15.9％),5.00-9.99 mg/dL in 26 cases (19.7％),10.00-14.99 mg/dL in 34 cases (25.8％),15.00-19.99 mg/dL in 37 cases (28.0％) and ≥ 20.00 mg/dL in 14 cases (10.6％).The card had the highest cap ability to recognize jaundice at the cheek,slightly lower at the sternum and the worst in the forehead.The cut-off of ≥ 12 on the six-color card at the cheek had a sensitivity of 95.95％,specificity of 74.14％,PPV of 82.56％,NPV of 93.48％,PLR of 3.710 and NLR of 0.055 for identifying neonates with TSB ≥ 12 mg/dL,with sensitivity being 98.08％,specificity 57.50％,PPV 60.00％,NPV 97.87％,PLR 2.308 and NLR 0.033 for TSB≥ 15 mg/dL.The identification rate was as follows:sensitivity of 100.00％,specificity of 46.00％,PPV of 37.21％,NPV of 100.00％ and PLR of 1.852 for predicting TSB ≥ 17 mg/dL.In addition,in the forehead,cheeks and sternum,the sensitivity of the cut-off of ≥ 12 on the card was 100.00％ for identifying neonates with TSB≥20 mg/dL.In the cheeks and the sternum,the cut-off of ≥ 15 on the card was with a sensitivity of 100.00％ for predicting TSB ≥ 20 mg/dL.Conclusion The six-color jaundice card is a potential screening tool for neonatal hyperbilirubinemia,and the cheek is the best measurement site.

Objective:To evaluate the diagnostic efficacy and practicality of the Jaundice color card (JCard) as a screening tool for neonatal jaundice.Methods:Following the standards for reporting of diagnostic accuracy studies (STARD) statement, a multicenter prospective study was conducted in 9 hospitals in China from October 2019 to September 2021. A total of 845 newborns who were admitted to the hospital or outpatient department for liver function testing due to their own diseases. The inclusion criteria were a gestational age of ≥35 weeks, a birth weight of ≥2 000 g, and an age of ≤28 days. The neonate′s parents used the JCard to measure jaundice at the neonate′s cheek. Within 2 hours of the JCard measurement, transcutaneous bilirubin (TcB) was measured with a JH20-1B device and total serum bilirubin (TSB) was detected. The Pearson′s correlation analysis, Bland-Altman plots and the receiver operating characteristic (ROC) curve were used for statistic analysis.Results:Out of the 854 newborns, 445 were male and 409 were female; 46 were born at 35-36 weeks of gestational age and 808 were born at ≥37 weeks of gestational age. Additionally, 432 cases were aged 0-3 days, 236 cases were aged 4-7 days, and 186 cases were aged 8-28 days. The TSB level was (227.4±89.6) μmol/L, with a range of 23.7-717.0 μmol/L. The JCard level was (221.4±77.0) μmol/L and the TcB level was (252.5±76.0) μmol/L. Both the JCard and TcB values showed good correlation ( r=0.77 and 0.80, respectively) and agreements (96.0% (820/854) and 95.2% (813/854) of samples fell within the 95% limits of agreement, respectively) with TSB. The JCard value of 12 had a sensitivity of 0.93 and specificity of 0.75 for identifying a TSB ≥205.2?μmol/L, and a sensitivity of 1.00 and specificity of 0.35 for identifying a TSB ≥342.0?μmol/L. The TcB value of 205.2?μmol/L had a sensitivity of 0.97 and specificity of 0.60 for identifying TSB levels of 205.2 μmol/L, and a sensitivity of 1.00 and specificity of 0.26 for identifying TSB levels of 342.0 μmol/L. The areas under the ROC curve (AUC) of JCard for identifying TSB levels of 153.9, 205.2, 256.5, and 342.0 μmol/L were 0.96, 0.92, 0.83, and 0.83, respectively. The AUC of TcB were 0.94, 0.91, 0.86, and 0.87, respectively. There were both no significant differences between the AUC of JCard and TcB in identifying TSB levels of 153.9 and 205.2 μmol/L (both P>0.05). However, the AUC of JCard were both lower than those of TcB in identifying TSB levels of 256.5 and 342.0 μmol/L (both P<0.05). Conclusions:JCard can be used to classify different levels of bilirubin, but its diagnostic efficacy decreases with increasing bilirubin levels. When TSB level are ≤205.2 μmol/L, its diagnostic efficacy is equivalent to that of the JH20-1B. To prevent the misdiagnosis of severe jaundice, it is recommended that parents use a low JCard score, such as 12, to identify severe hyperbilirubinemia (TSB ≥342.0 μmol/L).