Department of Population Medicine, Faculty of Medicine and Health Sciences, University Tunku Abdul Rahman, Selangor, Malaysia.
Department of Mathematical and Actuarial Sciences, Faculty of Engineering and Science, University Tunku Abdul Rahman, Selangor, Malaysia.
Pediatr Res. 2019 Aug;86(2):216-220. doi: 10.1038/s41390-019-0304-0. Epub 2019 Jan 23.
This study aimed to determine the accuracy of a point-of-care Bilistick method for measuring total serum bilirubin (TSB) and its turn-around-time (TAT) against hospital laboratory methods.
This prospective study was carried out on 561 term-gestation jaundiced neonates in two Malaysian hospitals. Venous blood sample was collected from each neonate for contemporary measurement of TSB by hospital laboratories and Bilistick. TAT was the time interval between specimen collection and TSB result reported by each method.
The mean laboratory-measured TSB was 194.85 (±2.844) µmol/L and Bilistick TSB was 169.37 (±2.706) µmol/L. Pearson's correlation coefficient was: r = 0.901 (p < 0.001). The mean difference of [laboratory TSB- Bilistick TBS] was 26.48 (±29.41) µmol/L. The Bland-Altman plots show that the 95% limits of agreement (-31.1577, 84.11772) contain 94.7% (=531/561) of the difference in TSB readings. Bilistick has a 99% accuracy and 100% sensitivity to predict laboratory TSB levels of ≥80 µmol/L and ≥360 µmol/L at lower Bilistick TSB levels of ≥55 and ≥315 µmol/L, respectively. TAT of Bilistick TSB (2.0 min) was significantly shorter than TAT (105 min) of laboratory TSB (p < 0.001).
Bilistick has shorter TAT. The accuracy and sensitivity of Bilistick TSB for predicting laboratory TSB is high at lower cutoff levels.
本研究旨在确定即时 Bilistick 法测量总血清胆红素（TSB）的准确性及其 turnaround-time（TAT）与医院实验室方法的对比。
这项前瞻性研究在马来西亚的两家医院进行，共纳入了 561 例足月黄疸新生儿。从每个新生儿采集静脉血样本，同时由医院实验室和 Bilistick 进行 TSB 即时测量。TAT 为两种方法报告 TSB 结果之间的时间间隔。
实验室测量的 TSB 平均值为 194.85（±2.844）µmol/L，Bilistick TSB 为 169.37（±2.706）µmol/L。Pearson 相关系数为：r=0.901（p<0.001）。[实验室 TSB-Bilistick TBS] 的平均差值为 26.48（±29.41）µmol/L。Bland-Altman 图显示，95%的一致性界限（-31.1577, 84.11772）包含了 TSB 读数差异的 94.7%（=531/561）。Bilistick 在 Bilistick TSB 水平较低（≥55 和≥315 µmol/L）时，预测实验室 TSB 水平≥80 µmol/L 和≥360 µmol/L 的准确性分别为 99%和 100%，灵敏度分别为 100%和 100%。Bilistick TSB 的 TAT（2.0 分钟）明显短于实验室 TSB 的 TAT（105 分钟）（p<0.001）。
Bilistick 有更短的 TAT。Bilistick TSB 在较低截断值水平预测实验室 TSB 的准确性和灵敏度较高。
