Diagnostic performance of point-of-care bilirubin testing with Bilistick 2.0 device at a South Indian clinical site.

Abstract

Background: Neonatal hyperbilirubinemia is common in India, yet many public hospitals lack access to reliable and timely bilirubin testing. We evaluated the diagnostic performance of a point-of-care (POC) bilirubin device, Bilistick 2.0, in a high-volume neonatal setting.

Methods: We conducted a prospective diagnostic accuracy study at Madras Medical College, Chennai. Neonates ≥28 weeks and ≤10 days old with jaundice or at high risk were enrolled. Paired TSB samples (Bilistick and reference lab) were collected from 153 neonates. Bland-Altman analysis, correlation, and subgroup comparisons were performed.

Results: Of 153 paired samples, 137 non-hemolyzed pairs were analyzed. Mean TSB was 14.39 ± 4.03 mg/dL (Bilistick) vs. 14.27 ± 3.73 mg/dL (reference). Mean absolute difference was 1.35 mg/dL; 79% of values were within ±2 mg/dL. Mean bias was +0.13 mg/dL. Correlation was r = 0.88 overall, and r = 0.96 for TSB > 20 mg/dL. Test failure rate was 10.5%, mostly during the initial learning phase.

Conclusion: Bilistick 2.0 showed strong diagnostic agreement with reference laboratory bilirubin testing. With training and basic laboratory coordination, it may support safe, rapid bilirubin management in resource-limited neonatal care.

Impact: The Bilistick 2.0 point-of-care device showed strong diagnostic agreement with reference laboratory bilirubin testing. Performance remained reliable in neonates with clinically significant bilirubin levels, especially >20 mg/dL. Turnaround time was under 15 min, and user-related test failures decreased after brief training. The device has potential for decentralized bilirubin monitoring in public-sector neonatal care in India.