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Updated: Feb 17, 2026

Biochemical Measurement of Neonatal Hypoxia
Published on: August 24, 2011
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.
Abstract:
Newborns are at increased risk of jaundice, a condition in which excess bilirubin accumulates in blood. Left untreated, jaundice can lead to neurological impairment and death. Jaundice resulting from unconjugated hyperbilirubinemia is easily treated with exposure to blue light, and phototherapy systems have been developed for low-resource settings; however, there are no appropriate solutions to diagnose and monitor jaundice in these settings. To address this need we present BiliSpec, a low-cost reader and disposable lateral flow card designed to measure the concentration of total bilirubin from several drops of blood at the point of care. We evaluated the performance of BiliSpec, using blood from normal volunteers spiked with varying amounts of bilirubin; results measured using BiliSpec correlated well with a reference laboratory bilirubinometer (r = 0.996). We then performed a pilot clinical study using BiliSpec to measure total bilirubin in neonates at risk for jaundice at Queen Elizabeth Central Hospital in Blantyre, Malawi. Concentrations measured using BiliSpec correlated well with those measured using a laboratory reference standard in 94 patient samples ranging from 1.1 mg/dL to 23.0 mg/dL in concentration (r = 0.973). The mean difference between bilirubin levels measured with BiliSpec and the reference standard was 0.3 mg/dL (95[Formula: see text] CI: -1.7-2.2 mg/dL).

