Global Newborn Health Laboratory, Department of Pediatric Newborn Medicine, Brigham and Women's Hospital and Harvard Medical School, Harvard University, Boston, Massachusetts;
Global Newborn Health Laboratory, Department of Pediatric Newborn Medicine, Brigham and Women's Hospital and Harvard Medical School, Harvard University, Boston, Massachusetts.
Pediatrics. 2019 May;143(5). doi: 10.1542/peds.2018-2039. Epub 2019 Apr 5.
Severe neonatal hyperbilirubinemia (>20 mg/dL) affects ∼1 million infants annually. Improved jaundice screening in low-income countries is needed to prevent bilirubin encephalopathy and mortality.
The Bili-ruler is an icterometer for the assessment of neonatal jaundice that was designed by using advanced digital color processing. A total of 790 newborns were enrolled in a validation study at Brigham and Women's Hospital (Boston) and Sylhet Osmani Medical College Hospital (Sylhet, Bangladesh). Independent Bili-ruler measurements were made and compared with reference standard transcutaneous bilirubin (TcB) and total serum bilirubin (TSB) concentrations.
Bili-ruler scores on the nose were correlated with TcB and TSB levels ( = 0.76 and 0.78, respectively). The Bili-ruler distinguished different clinical thresholds of hyperbilirubinemia, defined by TcB, with high sensitivity and specificity (score ≥3.5: 90.1% [95% confidence interval (CI): 84.8%-95.4%] and 85.9% [95% CI: 83.2%-88.6%], respectively, for TcB ≥13 mg/dL). The Bili-ruler also performed reasonably well compared to TSB (score ≥3.5: sensitivity 84.5% [95% CI: 79.1%-90.3%] and specificity 83.2% [95% CI: 76.1%-90.3%] for TSB ≥11 mg/dL). Areas under the receiver operating characteristic curve for identifying TcB ≥11, ≥13, and ≥15 were 0.92, 0.93, and 0.94, respectively, and 0.90, 0.87, and 0.86 for identifying TSB ≥11, ≥13, and ≥15. Interrater reliability was high; 97% of scores by independent readers fell within 1 score of one another ( = 88).
The Bili-ruler is a low-cost, noninvasive tool with high diagnostic accuracy for neonatal jaundice screening. This device may be used to improve referrals from community or peripheral health centers to higher-level facilities with capacity for bilirubin testing and/or phototherapy.
严重的新生儿高胆红素血症（>20mg/dL）每年影响约 100 万婴儿。需要在低收入国家改善黄疸筛查，以预防胆红素脑病和死亡率。
Bili-ruler 是一种用于评估新生儿黄疸的黄疸仪，它是通过使用先进的数字颜色处理技术设计的。共有 790 名新生儿在波士顿布莱根妇女医院（Brigham and Women's Hospital）和孟加拉国锡尔赫特奥萨马尼医学院医院（Sylhet Osmani Medical College Hospital）参加了一项验证研究。进行了独立的 Bili-ruler 测量，并与参考标准经皮胆红素（TcB）和总血清胆红素（TSB）浓度进行了比较。
鼻侧的 Bili-ruler 评分与 TcB 和 TSB 水平相关（分别为 0.76 和 0.78）。Bili-ruler 能够区分不同的 TcB 定义的高胆红素血症临床阈值，具有高灵敏度和特异性（评分≥3.5：90.1%[95%置信区间（CI）：84.8%-95.4%]和 85.9%[95%CI：83.2%-88.6%]，分别用于 TcB≥13mg/dL）。与 TSB 相比，Bili-ruler 的表现也相当不错（评分≥3.5：TSB≥11mg/dL 时的灵敏度为 84.5%[95%CI：79.1%-90.3%]，特异性为 83.2%[95%CI：76.1%-90.3%]）。识别 TcB≥11、≥13 和≥15 的受试者工作特征曲线下面积分别为 0.92、0.93 和 0.94，识别 TSB≥11、≥13 和≥15 的面积分别为 0.90、0.87 和 0.86。观察者间的可靠性很高；97%的独立评分相差 1 分（>88）。
Bili-ruler 是一种具有高诊断准确性的低成本、非侵入性新生儿黄疸筛查工具。该设备可用于改善从社区或基层卫生中心向具有胆红素检测和/或光疗能力的更高水平机构转诊的情况。
