Point-of-care device to diagnose and monitor neonatal jaundice in low-resource settings

Pelham A Keahey1, Mathieu L Simeral1, Kristofer J Schroder1

  • 1Department of Bioengineering, Rice University, Houston, TX 77030.

Insights

Newborn jaundice can be diagnosed and monitored using BiliSpec, a low-cost point-of-care device. This innovative system accurately measures total bilirubin levels in neonates, improving care in resource-limited settings.

Area of Science:

  • Biomedical Engineering
  • Neonatal Medicine
  • Point-of-Care Diagnostics

Background:

  • Neonatal jaundice, caused by excess bilirubin, poses a risk of neurological impairment.
  • Effective phototherapy exists, but diagnostic tools are lacking in low-resource settings.
  • Accurate and accessible jaundice monitoring is crucial for timely intervention.

Purpose of the Study:

  • To develop and evaluate BiliSpec, a low-cost point-of-care device for measuring total bilirubin in newborns.
  • To address the need for accessible jaundice diagnostics in resource-limited environments.

Main Methods:

  • BiliSpec utilizes a low-cost reader and disposable lateral flow cards for total bilirubin measurement.
  • Performance was evaluated using volunteer blood samples spiked with bilirubin, compared to a laboratory bilirubinometer.
  • A pilot clinical study was conducted in Malawi, measuring total bilirubin in at-risk neonates.

Main Results:

  • BiliSpec showed excellent correlation with a laboratory bilirubinometer in initial evaluations (r=0.996).
  • In a pilot clinical study, BiliSpec results correlated well with a laboratory reference standard (r=0.973) across a wide concentration range (1.1-23.0 mg/dL).
  • The mean difference between BiliSpec and reference standard measurements was minimal (0.3 mg/dL).

Conclusions:

  • BiliSpec is a reliable and accurate low-cost tool for measuring total bilirubin at the point of care.
  • This device has the potential to significantly improve the diagnosis and management of neonatal jaundice in resource-limited settings.
  • BiliSpec offers a viable solution for monitoring jaundice, enabling timely treatment and preventing severe outcomes.