Evidence map›Paper›PMID 41062819›Full record

ArticlePediatric research2026

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

Mangalabharathi Sundaram, Arunkumar Muthusamy, Anitha Balachandran, Muthukumaran Natarajan

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Article in Pediatric research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

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5 · Who and what money

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4 authors.

Mangalabharathi SundaramDepartment of Neonatology, Madras Medical College, Chennai, Tamil Nadu, India. drmangalabharathi@gmail.com.
Arunkumar MuthusamyDepartment of Neonatology, Madras Medical College, Chennai, Tamil Nadu, India.
Anitha BalachandranDepartment of Neonatology, Madras Medical College, Chennai, Tamil Nadu, India.
Muthukumaran NatarajanDepartment of Neonatology, Madras Medical College, Chennai, Tamil Nadu, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNeonatal 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.

methodsWe 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.

resultsOf 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.

conclusionBilistick 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.

Indexed as

BilirubinHyperbilirubinemia, NeonatalNeonatal ScreeningPoint-of-Care SystemsPoint-of-Care TestingFemaleHumansIndiaInfant, NewbornJaundice, NeonatalMaleProspective StudiesRapid Diagnostic TestsReproducibility of ResultsBilirubin

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