Department of Neonatology, Fernandez Hospital, Hyderabad, Telangana 500029, India.
J Trop Pediatr. 2020 Dec 1;66(6):630-636. doi: 10.1093/tropej/fmaa026.
Early diagnosis and appropriate management of neonatal jaundice is crucial in avoiding 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.
To assess the accuracy of Bilistick system, a PoC device, for measurement of TB in comparison with estimation by spectrophotometry.
DESIGN/METHODS: In this cross-sectional clinical study, in infants who required TB estimation, blood samples in 25-µl 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 ±2 mg/dl of bilirubin estimation by spectrophotometry was the primary outcome.
Among the enrolled infants, 198 infants were eligible for study analysis with the mean gestation of 36 ± 2.3 weeks and the mean birth weight of 2368 ± 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 ±2 mg/dl difference of TB measured by spectrophotometry. There was a moderate degree of correlation between the two methods (r = 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 ± 4.4) with limits of agreement between -8.2 and +9.1 mg/dl.
Bilistick as a PoC device is not accurate to estimate TB within the clinically acceptable difference (±2 mg/dl) of TB estimation by spectrophotometry and needs further improvement to make it more accurate.
早期诊断和适当管理新生儿黄疸对于避免严重高胆红素血症和脑损伤至关重要。目前需要一种经济实惠、微创、即时检测（Point-of-Care，PoC）工具，用于总胆红素（Total bilirubin，TB）的估计，该工具在各种胆红素值和所有环境下都能发挥作用。
评估 Bilistick 系统（一种 PoC 设备）测量 TB 的准确性，并与分光光度法估计值进行比较。
设计/方法：在这项横断面临床研究中，对于需要测量 TB 的婴儿，同时从静脉血中用 25-µl 移液管采集血液样本，用于实验室胆红素的估计。Bilisitck 系统在估计 TB 方面的准确性，以与分光光度法估计值相差±2mg/dl 为主要结局。
在纳入的婴儿中，有 198 名婴儿符合研究分析条件，平均胎龄为 36±2.3 周，平均出生体重为 2368±623g。登记时的中位年龄为 68.5 小时（四分位间距：48-92）。Bilisitck 系统在测量 TB 方面的准确性仅为 54.5%的婴儿，与分光光度法测量的 TB 值相差±2mg/dl。两种方法之间存在中度相关性（r=0.457；95%置信区间：0.339-0.561，p 值<0.001）。Bland-Altman 分析显示平均差值为 0.5mg/dl（SD±4.4），一致性界限为-8.2 和+9.1mg/dl。
Bilisitck 系统作为一种 PoC 设备，无法准确估计分光光度法估计值的±2mg/dl 内的 TB，需要进一步改进以提高其准确性。
