Validating a Sclera-Based Smartphone Application for Screening Jaundiced Newborns in Ghana

Abstract

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.

Demystifying non-invasive approaches for screening jaundice in low resource settings: a review

“…Several of the included studies conducted comparisons between the accuracy of Transcutaneous Bilirubin (TcB) and MAPB in their respective study cohorts. These investigations consistently favored TcB over MAPB in the estimation of TSB values ( 205 – 207 ). The reported correlations between TcB and TSB exhibited a range from 0.77 to 0.97, with the highest concordance observed in neonates during their initial hospitalization and the lowest in outpatient settings, where MAPB measurements are anticipated for employment ( 122 , 130 , 161 , 219 – 220 ).…”

“…In a collaborative clinical pilot, researchers conducted comprehensive studies on neonatal jaundice screening utilizing smartphone technology. The pilot involved 37 newborns at University College Hospital London, and a year-long study was carried out on 724 newborns in Ghana ( 207 ). To capture precise eye images, the research team employed a Samsung Galaxy SB smartphone, capturing two images per infant's eye—one with the LED flash activated and one without, effectively mitigating ambient light influence through ambient subtraction techniques.…”

Non-invasive detection of bilirubin concentrations during the first week of life in a low-resource setting along the Thailand-Myanmar border

“…Their reliability in populations with more pigmented skin has not been tested widely (19)(20)(21) represents an initial insurmountable investment for most constrained-resource settings, but other transcutaneous devices might be as accurate and more affordable (24). Other cheaper screening tools have been tested, such as icterometers (25,26) and phone-based apps (27)(28)(29), and when properly evaluated could be used by health workers at birthing centers and in remote settings, and even by parents (30) after discharge from the hospital.…”

Management challenges in the treatment of severe hyperbilirubinemia in low- and middle-income countries: Encouraging advancements, remaining gaps, and future opportunities

“…Another study in China demonstrated decreased neonatal readmission rate and decreased maternal anxiety scores for mother-infant dyads that used a smartphone app to monitor for neonatal jaundice at home under web-based guidance of pediatricians compared to the control group that received routine care ( 108 ). Similar smartphone-based detection tools are being studied in other regions of the world, including Singapore ( 109 ), Ghana ( 110 ), and Saudi Arabia ( 111 ), and Nigeria ( 112 ), just to name a few. Although these tools are best suited as screening devices, as with the TcB, they are encouraging uses of state-of-the-art technology to improve the recognition and diagnosis of NJ.…”