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Background <p>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.</p> Methods <p>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.</p> Results <p>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 <i>r</i> = 0.88 overall, and <i>r</i> = 0.96 for TSB &gt; 20 mg/dL. Test failure rate was 10.5%, mostly during the initial learning phase.</p> Conclusion <p>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.</p> Impact <p><UnorderedList Mark="Bullet"> <ItemContent> <p>The Bilistick 2.0 point-of-care device showed strong diagnostic agreement with reference laboratory bilirubin testing.</p> </ItemContent> <ItemContent> <p>Performance remained reliable in neonates with clinically significant bilirubin levels, especially &gt;20 mg/dL.</p> </ItemContent> <ItemContent> <p>Turnaround time was under 15 min, and user-related test failures decreased after brief training.</p> </ItemContent> <ItemContent> <p>The device has potential for decentralized bilirubin monitoring in public-sector neonatal care in India.</p> </ItemContent> </UnorderedList></p>

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

  • 期刊论文

  • 发表日期：

    2025年10月8日

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  • Mangalabharathi Sundaram,
  • Arunkumar Muthusamy,
  • Anitha Balachandran,
  • Muthukumaran Natarajan

摘要

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.