ORIGINAL ARTICLE Comparison between Bilistick System and transcutaneous bilirubin in assessing total bilirubin serum concentration in jaundiced newborns C Greco 1,5 , IF Iskander 2,5 , DM Akmal 2 , SZ El Houchi 2 , DA Khairy 2 , G Bedogni 3 , RP Wennberg 4 , C Tiribelli 1,3 and CD Coda Zabetta 1 OBJECTIVE: To compare the performance and accuracy of the JM-103 transcutaneous bilirubinometer and Bilistick System in measuring total serum bilirubin for the early identification of neonatal hyperbilirubinemia. STUDY DESIGN: The study was performed on 126 consecutive term and near-term (⩾36 weeks' gestational age) jaundiced newborns in Cairo University Children Hospital NICU, Egypt. Total serum bilirubin was assayed concurrently by the clinical laboratory and Bilistick System and estimated using the JM-103 transcutaneous bilirubin instrument. Bland–Altman analysis was used to evaluate the agreement between determinations. RESULT: The limits of agreement of the Bilistick System (-5.8 to 3.3 mg dl - 1 ) and JM-103 system (-5.4 to 6.0 mg dl - 1 ) versus the clinical laboratory results were similar. CONCLUSION: The Bilistick System is an accurate alternative to transcutaneous (TcB) determination for early diagnosis and proper management of the neonatal jaundice. Journal of Perinatology advance online publication, 15 June 2017; doi:10.1038/jp.2017.94 INTRODUCTION Neonatal jaundice is a physiologic condition characterized by the increase in total bilirubin concentration in the blood, occurring in 60 to 80% of term newborns worldwide. 1 Under normal conditions, the bilirubin concentration should return to normal value within 2 weeks of age. Unfortunately, in some cases severe hyperbilirubinemia occurs and can lead to acute bilirubin encephalopathy and kernicterus/chronic bilirubin encephalopathy (CBE), 2 accounting for long-term morbidity and sometimes mortality in healthy late-preterm and full-term infants. 3 CBE is rare in wealthy first world countries, but severe hyperbilirubinemia and encephalopathy continue to occur in many poorly resourced countries. 4,5 Screening total bilirubin levels in babies before hospital discharge has become routine in most affluent country hospitals. 6 The methods commonly used in clinical practice are laboratory measurement of the total serum bilirubin (TSB) or pre- discharge transcutaneous (TcB) bilirubin determination. Unfortu- nately, TcB instruments are expensive, and effective laboratory support is often not available in poorly resourced countries, is often inaccurate and reports delayed for hours. 4,7 TcB bilirubin determination is a non-invasive, painless method frequently used for bilirubin screening in jaundiced infants. 8 Its use as an alternative to laboratory TBS measurement for screening was recommended by the American Academy of Pediatrics (AAP) in 2004. 9 This methodology is based on the estimation of bilirubin concentration using optical spectroscopy and provides instanta- neous, non-invasive estimates of TcB bilirubin concentration. A major limitation is the tendency to underestimate bilirubin levels. 10 Furthermore, TcBs have limited measurement scales (up to 15 or 20 mg dl - 1 , depending on the instrument) and their accuracy is known mostly for Caucasian newborns. 11 In African- American newborns, TcB is often not accurate and significantly overestimates TSB levels 12,13 especially in infants with relatively high TSB value. In addition, the association between TcB and serum bilirubin level becomes increasingly weaker in premature babies less than 30 weeks' gestation and in those who had already received phototherapy. 14,15 A new method for TSB determination, the Bilistick System (BS, Bilimetrix, Trieste, Italy), was recently developed with the aim of facilitating early diagnosis of hyperbilirubinemia. 16 BS is a Point of Care method used for measuring TSB in newborns’ blood samples with values up to 40 mg dl - 1 . The main advantages are its ease of use, quick results, low cost, portability, sample size of only 25 μl whole blood and no need for sample preparation or reagents. 16 These characteristics make it suitable for screening bilirubin levels of babies in low-resource primary-care facilities 17 and during home-care visits by nurse or midwife. 18,19 The present study compares the accuracy of the JM-103 TcB device and the BS in determining total bilirubin using the standard laboratory as reference method. METHODS The present study was conducted from April to November 2015 at the Neonatal Intensive Care Unit (NICU) of Cairo University Children’s Hospital, a tertiary care referral center admitting about 250 severely jaundiced neonates each year. 20,21 The study included a total of 126 newborns with gestational age of 436 weeks’ readmitted and investigated for jaundiced as prescribed by the caring physician. Gestational age, sex, weight and age at admission were recorded. 1 Bilimetrix s.r.l., AREA Science Park, Trieste, Italy; 2 Department of Pediatrics, Cairo University Children Hospital, Cairo, Egypt; 3 Fondazione Italiana Fegato-Onlus, AREA Science Park, Trieste, Italy and 4 Department of Pediatrics, University of Washington, Seattle, WA, USA. Correspondence: Professor C Tiribelli, Bilimetrix s.r.l., and Fondazione Italiana Fegato-Onlus, AREA Science Park, Building Q, SS14 km 163.5, Trieste 34149, Italy. E-mail: ctliver@fegato.it 5 These authors contributed equally to this work. Received 17 February 2017; revised 11 May 2017; accepted 12 May 2017 Journal of Perinatology (2017) 00, 1 – 4 © 2017 Nature America, Inc., part of Springer Nature. All rights reserved 0743-8346/17 www.nature.com/jp