Liver Research Centre, Italian Liver Foundation, Trieste, Italy.
Neonatology. 2013;103(3):177-81. doi: 10.1159/000345425. Epub 2012 Dec 22.
Severe neonatal hyperbilirubinemia, with consequent encephalopathy, remains a common cause of morbidity and death in many regions of the world. Poor access to clinical laboratory resources and screening programs to measure plasma bilirubin levels is a major contributor to delayed treatment in developing countries, and the cost of existing point-of-care screening instruments precludes their dissemination.
We are evaluating the accuracy of a low-cost, minimally invasive point-of-care system (Bilistick) requiring a 25-µl blood sample that could be used in low-resource environments to evaluate patients with neonatal jaundice.
We compared plasma bilirubin levels in divided blood samples by clinical laboratories and by Bilistick at two medical centers serving term and near-term newborns from ethnically different populations.
118 neonates with bilirubin levels ranging from 24.8 to 501.0 µmol/l were analyzed. The mean bilirubin concentration (±SD) was 215.6 ± 85.5 µmol/l for Bilistick and 226.1 ± 86.4 µmol/l by laboratory determination. Pearson's correlation coefficient between all paired results was 0.961, and the Bland-Altman analysis showed a mean difference of 10.3 µmol/l with a 95% interval of agreement of -38.0 to 58.7 µmol/l.
Bilistick is a minimally invasive method for measuring total bilirubin concentration over a wide range of values and should provide an affordable and accurate system for pre-discharge and follow-up screening of jaundiced infants, particularly in low-resource environments.
严重的新生儿高胆红素血症，进而导致脑病，在世界许多地区仍是发病率和死亡率的一个常见原因。在发展中国家，由于临床实验室资源和血浆胆红素水平筛查方案获取不足，导致治疗延迟，而现有的即时检测筛查仪器费用昂贵，也阻碍了其推广。
我们正在评估一种低成本、微创的即时检测系统（Bilistick）的准确性，该系统需要 25μl 的血样，可在资源匮乏的环境中用于评估患有新生儿黄疸的患者。
我们比较了在为不同种族人群提供足月和近足月新生儿服务的两个医疗中心，由临床实验室和 Bilistick 检测的等分血样的血浆胆红素水平。
共分析了 118 例胆红素水平在 24.8 至 501.0μmol/l 之间的新生儿。Bilistick 检测的胆红素平均浓度（±SD）为 215.6±85.5μmol/l，实验室检测为 226.1±86.4μmol/l。所有配对结果的 Pearson 相关系数为 0.961，Bland-Altman 分析显示平均差值为 10.3μmol/l，95%一致性区间为-38.0 至 58.7μmol/l。
Bilistick 是一种微创方法，可测量宽范围胆红素浓度，应为在资源匮乏环境中，用于经皮黄疸仪筛查后出院前和随访时筛查黄疸婴儿提供一种经济、准确的系统。
