Validation of a Mobile Health Device for Neonatal Jaundice Screening: A Cross-Sectional Study in a Resource-Limited Setting in Mexico

Abstract

Objective: To evaluate the performance of Picterus Jaundice Pro (Picterus JP), a mobile health device for neonatal jaundice (NNJ) screening, in Mexican newborns. Methodology: A cross-sectional study was conducted from January 2023 to June 2024 at a hospital in a resource-limited setting in Mexico. The main outcomes were Picterus JP measurements and total serum bilirubin (TSB) levels. Results: A total of 177 term newborns, aged 1 to 14 days, were enrolled. Picterus JP showed a significant positive Spearman’s rho correlation with TSB (ρ = .68), sensitivity of 85.7% and specificity of 80.1% to detect TSB ≥ 250 using Picterus cut off value of 202 µmol/L. However, it tended to underestimate higher bilirubin levels. Conclusion: Picterus JP shows potential to be a useful tool for NNJ screening, particularly in resource-limited areas. Further validation across more diverse populations and clinical environments, alongside accuracy improvements, is necessary to enhance its utility and support wider implementation. Registered in ClinicalTrials.gov (https://clinicaltrials.gov/study/NCT06276582)