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  • Clinical Research Article
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Diagnostic performance of point-of-care bilirubin testing with Bilistick 2.0 device at a South Indian clinical site

Pediatric Research (2025)Cite this article

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.

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Data availability

The datasets generated and/or analyzed during the current study are not publicly available due to institutional policy and participant confidentiality, but are available from the corresponding author on reasonable request.

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Acknowledgements

The authors thank Professor Vinod K. Bhutani and Professor Claudio Tiribelli for their expert guidance throughout the study. The authors also acknowledge Mr. Sashi Kumar of Phoenix Medical Systems, and the team at Bilimetrix, for their support in providing the Bilistick 2.0 devices and consumables required for this research. The authors gratefully acknowledge the Government of India, Ministry of Health & Family Welfare, Department of Health Research, Multidisciplinary Research Unit (MRU), and the infrastructural facility of Madras Medical College.

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Authors and Affiliations

  1. Department of Neonatology, Madras Medical College, Chennai, Tamil Nadu, India

    Mangalabharathi Sundaram, Arunkumar Muthusamy, Anitha Balachandran & Muthukumaran Natarajan

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  1. Mangalabharathi Sundaram
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  2. Arunkumar Muthusamy
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  3. Anitha Balachandran
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  4. Muthukumaran Natarajan
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Contributions

Substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data: Mangalabharathi Sundaram, Arunkumar Muthusamy, Anitha Balachandran, Muthukumaran Natarajan. Drafting the article or revising it critically for important intellectual content: Mangalabharathi Sundaram, Arunkumar Muthusamy, Anitha Balachandran, Muthukumaran Natarajan. Final approval of the version to be published: Mangalabharathi Sundaram, Arunkumar Muthusamy, Anitha Balachandran, Muthukumaran Natarajan.

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Correspondence to Mangalabharathi Sundaram.

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Sundaram, M., Muthusamy, A., Balachandran, A. et al. Diagnostic performance of point-of-care bilirubin testing with Bilistick 2.0 device at a South Indian clinical site. Pediatr Res (2025). https://doi.org/10.1038/s41390-025-04431-0

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