Xue G C, Zhang H L, Ding X X, Xiong F, Liu Y H, Peng H, Wang C L, Zhao Y, Yan H L, Ren M X, Ma C Y, Lu H M, Li Y L, Meng R F, Xie L J, Chen N, Cheng X F, Wang J J, Xin X H, Wang R F, Jiang Q, Zhang Y, Liang G J, Li Y Z, Kang J N, Zhang H M, Zhang Y Y, Yuan Y, Li Y W, Su Y L, Liu J P, Duan S J, Liu Q S, Wei J
Department of Pediatrics, Wuxi 9th People's Hospital Affiliated to Soochow University, Wuxi 214062, China.
Department of Pediatrics, Zhenping People's Hospital, Nanyang 474250, China.
Zhonghua Er Ke Za Zhi. 2024 Jun 2;62(6):535-541. doi: 10.3760/cma.j.cn112140-20231106-00348.
To evaluate the diagnostic efficacy and practicality of the Jaundice color card (JCard) as a screening tool for neonatal jaundice. 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. 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 (=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 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 <0.05). 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).
评估黄疸色卡（JCard）作为新生儿黄疸筛查工具的诊断效能和实用性。按照诊断准确性研究报告标准（STARD）声明，于2019年10月至2021年9月在中国9家医院开展了一项多中心前瞻性研究。共有845例因自身疾病入院或门诊进行肝功能检测的新生儿。纳入标准为胎龄≥35周、出生体重≥2000g且年龄≤28天。新生儿父母使用JCard在新生儿脸颊测量黄疸。在JCard测量后2小时内，使用JH20 - 1B设备测量经皮胆红素（TcB）并检测总血清胆红素（TSB）。采用Pearson相关分析、Bland - Altman图和受试者操作特征（ROC）曲线进行统计分析。854例新生儿中，男性445例，女性409例；46例出生时胎龄为35 - 36周，808例出生时胎龄≥37周。此外，432例年龄为0 - 3天，236例年龄为4 - 7天，186例年龄为8 - 28天。TSB水平为（227.4±89.6）μmol/L，范围为23.7 - 717.0μmol/L。JCard水平为（221.4±77.0）μmol/L，TcB水平为（252.5±76.0）μmol/L。JCard和TcB值与TSB均显示出良好的相关性（分别为=0.77和0.80）和一致性（分别有96.0%（820/854）和95.2%（813/854）的样本落在95%一致性界限内）。JCard值为12时，识别TSB≥205.2μmol/L的灵敏度为0.93，特异度为0.75；识别TSB≥342.0μmol/L的灵敏度为1.00，特异度为0.35。TcB值为205.2μmol/L时，识别TSB水平为205.2μmol/L的灵敏度为0.97，特异度为0.60；识别TSB水平为342.0μmol/L的灵敏度为1.00，特异度为0.26。JCard识别TSB水平为153.9、205.2、256.5和342.0μmol/L时的ROC曲线下面积（AUC）分别为0.96、0.92、0.83和0.83。TcB的AUC分别为0.94、0.91、0.86和0.87。JCard和TcB在识别TSB水平为153.9和205.2μmol/L时的AUC均无显著差异（均P>0.05）。然而，JCard在识别TSB水平为256.5和342.0μmol/L时的AUC均低于TcB（均P<0.05）。JCard可用于对不同胆红素水平进行分类，但其诊断效能随胆红素水平升高而降低。当TSB水平≤205.2μmol/L时，其诊断效能与JH20 - 1B相当。为防止严重黄疸的误诊，建议家长使用较低的JCard评分，如12，来识别严重高胆红素血症（TSB≥342.0μmol/L）。
