OBJECTIVES Reducing the burden of bilirubin-induced neurologic complications in low-resource countries requires reliable and accessible screening tools. We sought to optimize and validate a sclera-based smartphone application, Neonatal Scleral-Conjunctival Bilirubin (neoSCB), for screening neonatal jaundice. METHODS Using a cross-sectional design, consecutive eligible infants (aged 0-28 days, in the hospital, not critically ill) were enrolled in Ghana from March 2019 to April 2020. Jaundice screening was performed with neoSCB (Samsung Galaxy S8) to quantify SCB and JM-105 (Dräger) for transcutaneous bilirubin (TcB). Screening values were compared with total serum bilirubin (TSB) measured at the point of care. RESULTS Overall, 724 infants participated in the optimization and validation phases of the study. The analysis for validation included 336 infants with no previous treatment of jaundice. Single neoSCB image captures identified infants with TSB >14.62 mg/dL (250 μmol/L) with reasonably high sensitivity, specificity, and receiver operating characteristic area under the curve at 0.94 (95% confidence interval [CI], 0.91 to 0.97), 0.73 (95% CI, 0.68 to 0.78), and 0.90, respectively. These findings were comparable to the sensitivity and specificity of JM-105 (0.96 [95% CI, 0.90 to 0.99] and 0.81 [95% CI, 0.76 to 0.86], respectively). The TcB/TSB had a larger correlation coefficient (r = 0.93; P < .01) than SCB/TSB (r = 0.78; P < .01). Performance of both devices was lower in infants with previous phototherapy (n = 231). CONCLUSIONS The diagnostic performance of neoSCB was comparable to JM-105 and is a potential, affordable, contact-free screening tool for neonatal jaundice.

中文翻译：

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验证用于筛查加纳黄疸新生儿的基于巩膜的智能手机应用程序。

目标 在资源匮乏的国家减少胆红素引起的神经系统并发症的负担需要可靠且易于使用的筛查工具。我们试图优化和验证基于巩膜的智能手机应用程序新生儿巩膜-结膜胆红素 (neoSCB)，用于筛查新生儿黄疸。方法 采用横断面设计，从 2019 年 3 月至 2020 年 4 月在加纳连续招募符合条件的婴儿（0-28 天，住院，非危重）。使用 neoSCB（三星 Galaxy S8）进行黄疸筛查以量化SCB 和 JM-105 (Dräger) 用于经皮胆红素 (TcB)。将筛查值与护理点测量的总血清胆红素 (TSB) 进行比较。结果 总体而言，724 名婴儿参与了研究的优化和验证阶段。验证分析包括 336 名既往未接受过黄疸治疗的婴儿。单个 neoSCB 图像捕获 TSB >14.62 mg/dL (250 μmol/L) 的已识别婴儿，具有相当高的灵敏度、特异性和曲线下接受者操作特征面积为 0.94（95% 置信区间 [CI]，0.91 至 0.97），分别为 0.73（95% CI，0.68 至 0.78）和 0.90。这些发现与 JM-105 的敏感性和特异性相当（分别为 0.96 [95% CI，0.90 至 0.99] 和 0.81 [95% CI，0.76 至 0.86]）。TcB/TSB 的相关系数 (r = 0.93; P < .01) 大于 SCB/TSB (r = 0.78; P < .01)。既往接受过光疗的婴儿（n = 231），两种设备的性能均较低。结论 neoSCB 的诊断性能与 JM-105 相当，是一种潜在的、负担得起的、