Department of Pediatrics, Faculty of Medicine Universitas Airlangga, Dr. Soetomo General Hospital Surabaya, Surabaya, Indonesia.
Department of Pediatrics, Beatrix Children's Hospital, University Medical Center Groningen, Groningen, The Netherlands.
Neonatology. 2021;118(6):678-684. doi: 10.1159/000518653. Epub 2021 Nov 15.
Recently, the Bilistick®, a point-of-care instrument to measure bilirubin levels, has been developed. It is fast and cheaper than transcutaneous bilirubin (TCB)-measuring devices, but data on diagnostic properties are scarce.
This study aimed to compare the performance of the Bilistick® (BM-BS 1.0 - FW version 2.0.1) and the JM-105 bilirubinometer for measuring bilirubin.
This is a prospective study in infants born after ≥32 weeks' gestation, and/or a birth weight of ≥1,500 g, and a postnatal age ≤14 days in Surabaya, Indonesia. Bilirubin was measured with the Bilistick® System (BM-BS 1.0 - FW version 2.0.1), transcutaneously (TCB) with the JM-105 bilirubinometer, and in serum (TSB) with a routine laboratory technique. Mean differences and 95% limits of agreement (LOA) and correlations were calculated.
We enrolled 149 neonates and 126 had paired measurements of Bilistick® bilirubin, TCB, and TSB. Bilistick® failed in 16 (10.7%) infants. Mean Bilistick® bilirubin-TSB difference was -11 µmol/L (95% LOA: -101 to 79 µmol/L) and r = 0.738 (p < 0.001). Mean TCB-TSB difference was 26 μmol/L (95% LOA: -33 to 88) and r = 0.785 (p < 0.001). The sensitivity, specificity, PPV, and NPV for Bilistick® bilirubin for a TSB above treatment thresholds were 0.74, 0.84, 0.67, and 0.88, respectively, and for TCB 0.92, 0.64, 0.54, and 0.95, respectively.
The Bilistick® System (BM-BS 1.0 - FW version 2.0.1) underestimates TSB, whereas TCB overestimates TSB in jaundiced Indonesian infants. Further improvement of Bilistick®'s diagnostic accuracy with less false-negative readings is essential to increase its use.
最近，一种名为 Bilistick®的即时检测仪器已经被开发出来，可以用于测量胆红素水平。与经皮胆红素（TCB）测量设备相比，它更快、更便宜，但关于其诊断性能的数据却很少。
本研究旨在比较 Bilistick®（BM-BS 1.0-FW 版本 2.0.1）和 JM-105 胆红素计测量胆红素的性能。
这是一项在印度尼西亚泗水进行的前瞻性研究，纳入胎龄≥32 周、出生体重≥1500g、出生后年龄≤14 天的婴儿。使用 Bilistick®系统（BM-BS 1.0-FW 版本 2.0.1）经皮（TCB）测量 JM-105 胆红素计和血清（TSB）胆红素。计算平均差异和 95%的一致性界限（LOA）和相关性。
我们共纳入了 149 名新生儿，其中 126 名有 Bilistick®胆红素、TCB 和 TSB 的配对测量值。16 名（10.7%）婴儿的 Bilistick®失败。Bilisitck®与 TSB 的胆红素平均差异为-11μmol/L（95% LOA：-101 至 79μmol/L），r=0.738（p<0.001）。TCB-TSB 的平均差异为 26μmol/L（95% LOA：-33 至 88），r=0.785（p<0.001）。Bilisitck®胆红素用于 TSB 治疗阈值以上的敏感性、特异性、PPV 和 NPV 分别为 0.74、0.84、0.67 和 0.88，TCB 分别为 0.92、0.64、0.54 和 0.95。
Bilisitck®系统（BM-BS 1.0-FW 版本 2.0.1）低估了 TSB，而 TCB 则高估了印度尼西亚黄疸婴儿的 TSB。进一步提高 Bilistick®的诊断准确性，减少假阴性读数，对于增加其使用至关重要。
