New point-of-care device shows promise for accurate bilirubin testing

This pilot study evaluates a newly developed point-of-care (PoC) device designed to measure bilirubin levels in human blood serum using a microfluidic cartridge and optoelectronic sensing module. Accurate bilirubin measurement is critical for assessing liver function and diagnosing conditions such as jaundice and neonatal hyperbilirubinemia. Traditional laboratory methods are accurate but not suitable for rapid or resource-limited settings due to their complexity. The goal of this study was to determine if the new portable PoC device could deliver comparable accuracy and clinical utility.

Serum samples from 20 patients with bilirubin concentrations ranging from 2 μmol/L to 480 μmol/L were analyzed using both the PoC device and a standard laboratory method (the diazo method via the Abbott Alinity system). The PoC device employed dual-wavelength light detection (455 nm and 530 nm) and microfluidic flow to analyze small-volume samples. The results showed a strong correlation (R² = 0.986) between the PoC and lab measurements. Bland-Altman analysis showed a small mean difference (−5.6 μmol/L) with no systematic bias. Receiver operating characteristic (ROC) analysis demonstrated high diagnostic performance, with 90% sensitivity and 97% specificity in classifying bilirubin levels across clinical thresholds.

The study concludes that the microfluidic-based PoC device offers a promising alternative for bilirubin testing, especially in settings where traditional lab infrastructure is unavailable. Although the sample size was small, the device met clinical accuracy standards and performed well compared to existing PoC solutions like Bilistick and BiliDx. The authors recommend larger-scale studies for further validation, including testing in patient populations with varying clinical profiles such as neonates and individuals with liver disease.