Reliability and Validity of a Smartphone-Paired Pulse Oximeter for Screening of Critical Congenital Heart Defects in Newborns

Neonatology. 2017;112(4):324-329. doi: 10.1159/000477294. Epub 2017 Aug 3.


Background: Barriers to widespread implementation of pulse oximetry screening of critical congenital heart defects (CCHD) in newborns include increasing trends of out-of-hospital births and cost of equipment. In recent years, smartphone-compatible pulse oximeters have appeared on the market, but the validity of such devices in the setting of CCHD screening has not been evaluated.

Objectives: To compare the performance in CCHD screening of a smartphone-paired pulse oximeter (Masimo iSpO2-Rx™) and a hospital-grade pulse oximeter (Masimo Radical-7™).

Methods: Preductal (right hand) and postductal (either foot) saturations were determined in a population of 201 term newborns by 2 independent teams, one using the Radical-7 and the other using the iSpO2-Rx. Bland-Altman analysis was applied to calculate mean bias and 95% limits of agreement between the 2 pulse oximeters.

Results: For the preductal oxygen saturation, the mean bias (Radical-7 minus iSpO2-Rx) was -0.08 (SD 1.76) and the lower and upper limits of agreement were -3.52 and 3.36, respectively. For the postductal oxygen saturation, the mean bias was -0.11 (SD 1.68) and the lower and upper limits of agreement were -3.49 and 3.18, respectively. In addition, the iSpO2-Rx provided reliable measurements of saturations below 95% in a group of 12 infants admitted to the neonatal intensive care unit.

Conclusions: Our data suggest that CCHD screening with the Masimo iSpO2-Rx is feasible and accurate. The use of reliable smartphone-paired pulse oximeters may contribute to the extension of CCHD screening to home births and low resource settings.

Keywords: Critical congenital heart defects; Pulse oximetry; Screening; Smartphone.

Publication types

  • Comparative Study
  • Validation Study

MeSH terms

  • Biomarkers / blood
  • Critical Illness
  • Diagnosis, Computer-Assisted / instrumentation*
  • Heart Defects, Congenital / blood
  • Heart Defects, Congenital / diagnosis*
  • Humans
  • Infant, Newborn
  • Mobile Applications*
  • Neonatal Screening / instrumentation*
  • Oximetry / instrumentation*
  • Oxygen / blood*
  • Predictive Value of Tests
  • Reproducibility of Results
  • Smartphone*


  • Biomarkers
  • Oxygen