Harpavat Sanjiv, Ramraj Ramya, Finegold Milton J, Brandt Mary L, Hertel Paula M, Fallon Sara C, Shepherd Ross W, Shneider Benjamin L
*Department of Pediatrics, Division of Gastroenterology, Hepatology, and Nutrition†Department of Pathology‡Department of Surgery, Division of Pediatric Surgery, Baylor College of Medicine and Texas Children's Hospital, Houston.
J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):799-803. doi: 10.1097/MPG.0000000000001097.
Although screening for biliary atresia (BA) is associated with improved outcomes, no screening program currently exists in the United States. In this study, we explore the possibility of a screening strategy based on newborn direct or conjugated bilirubin (DB or CB) measurements. Our objective is to estimate testing's sensitivity and specificity for BA.
Two groups were examined retrospectively. For sensitivity calculations, a BA group consisting of infants born between January 2011 and December 2014, diagnosed with BA, and cared for at a pediatric gastroenterology referral center was examined. For specificity calculations, a non-BA group that comprised of infants born between June 2009 and August 2011 in a hospital with a policy of checking newborn bilirubin concentrations was studied.
All 35 infants with newborn DB or CB measurements in the BA group had elevated concentrations, translating to a sensitivity of 100% (95% CI 87.7-100). In the non-BA group, 8936 of 9102 infants had DB concentrations within the laboratory's reference interval, translating to a specificity of 98.2% (95% CI 97.9-98.4). Three methods-calculating direct:total bilirubin ratios, using 99% reference intervals, and repeat testing-changed specificity to different degrees.
Newborn DB or CB measurements may have a high sensitivity and specificity for BA. Specificity can be further improved by using 99% reference intervals and/or repeat testing. Our findings can serve as the foundation for larger prospective studies, to determine whether newborn DB or CB measurements can be an effective screening strategy for BA.
尽管筛查胆道闭锁（BA）与改善预后相关，但美国目前尚无筛查项目。在本研究中，我们探讨基于新生儿直接胆红素或结合胆红素（DB或CB）测量的筛查策略的可能性。我们的目的是估计该检测对BA的敏感性和特异性。
回顾性检查两组。为计算敏感性，检查了一个BA组，该组由2011年1月至2014年12月出生、被诊断为BA并在儿科胃肠病学转诊中心接受治疗的婴儿组成。为计算特异性，研究了一个非BA组，该组由2009年6月至2011年8月在一家有检查新生儿胆红素浓度政策的医院出生的婴儿组成。
BA组中所有35例进行了新生儿DB或CB测量的婴儿浓度均升高，敏感性为100%（95%CI 87.7 - 100）。在非BA组中，9102例婴儿中有8936例DB浓度在实验室参考区间内，特异性为98.2%（95%CI 97.9 - 98.4）。三种方法——计算直接胆红素与总胆红素比值、使用99%参考区间以及重复检测——在不同程度上改变了特异性。
新生儿DB或CB测量对BA可能具有高敏感性和特异性。通过使用99%参考区间和/或重复检测可进一步提高特异性。我们的研究结果可为更大规模的前瞻性研究奠定基础，以确定新生儿DB或CB测量是否可成为BA的有效筛查策略。
