Accuracy of Bilistick (a Point-of-Care Device) to Detect Neonatal Hyperbilirubinemia Bhargavi Kamineni, MD, Anusha Tanniru, MD, Venkateshwarlu Vardhelli, DNB , Deepak Sharma, MD, Dinesh Pawale, DNB, Dattatray Kulkarni, DNB , Pranitha Reddy Muppidi, DCH, Saikiran Deshabhotla, MD, DNB, and Srinivas Murki, MD, DM Department of Neonatology, Fernandez Hospital, Hyderabad, Telangana 500029, India Correspondence: Vardhelli Venkateshwarlu, Department of Neonatology, Fernandez Hospital, Unit-2, H.No: 3-6-282, Opp: Old MLA Quarters, Hyderguda, Hyderabad, Telangana 500029, India. Tel: 897-804-8072; E-mail: <venkat959@gmail.com>. ABSTRACT Introduction: Early diagnosis and appropriate management of neonatal jaundice is crucial in avoid- ing severe hyperbilirubinemia and brain injury. A low-cost, minimally invasive, point-of-care (PoC) tool for total bilirubin (TB) estimation which can be useful across all ranges of bilirubin values and all settings is the need of the hour. Objective: To assess the accuracy of Bilistick system, a PoC device, for measurement of TB in com- parison with estimation by spectrophotometry. Design/methods: In this cross-sectional clinical study, in infants who required TB estimation, blood samples in 25-ml sample transfer pipettes were collected at the same time from venous blood obtained for laboratory bilirubin estimation. The accuracy of Bilistick in estimating TB within 62 mg/dl of bilirubin estimation by spectrophotometry was the primary outcome. Results: Among the enrolled infants, 198 infants were eligible for study analysis with the mean gestation of 36 6 2.3 weeks and the mean birth weight of 2368 6 623 g. The median age at enrollment was 68.5 h (interquartile range: 48–92). Bilistick was accurate only in 54.5% infants in measuring TB within 62 mg/ dl difference of TB measured by spectrophotometry. There was a moderate degree of correlation between the two methods (r ¼ 0.457; 95% CI: 0.339–0.561, p value < 0.001). Bland–Altman analysis showed a mean difference of 0.5 mg/dl (SD 6 4.4) with limits of agreement between 8.2 and þ9.1 mg/dl. Conclusion: Bilistick as a PoC device is not accurate to estimate TB within the clinically acceptable difference (62 mg/dl) of TB estimation by spectrophotometry and needs further improvement to make it more accurate. KEYWORDS : neonatal jaundice, bilirubin, Bilistick, hyperbilirubinemia, point-of-care device INTRODUCTION Neonatal jaundice is a common clinical condition during early neonatal period which is seen in nearly 80% of term newborns [1]. Approximately 5–10% of term neonates have clinically significant hyperbilir- ubinemia mandating the use of phototherapy [2, 3]. V C The Author(s) [2020]. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com  630 Journal of Tropical Pediatrics, 2020, 66, 630–636 doi: 10.1093/tropej/fmaa026 Advance Access Publication Date: 20 May 2020 Original paper Downloaded from https://academic.oup.com/tropej/article/66/6/630/5841166 by guest on 27 June 2022