Starowicz Olivia, Edwards Philippa, Schmidt Peter, Birch Pita
Newborn Care Unit, Gold Coast University Hospital, Gold Coast, Queensland, Australia.
Department of Neonatology, Mater Health Services, Brisbane, Queensland, Australia.
J Paediatr Child Health. 2020 Feb;56(2):283-288. doi: 10.1111/jpc.14597. Epub 2019 Aug 28.
To evaluate the accuracy of the Kejian 8000 (KJ-8000) transcutaneous bilirubinometer in infants of differing ethnicity and gestational age.
This was a prospective study of infants in the Newborn Care Unit at Gold Coast University Hospital. Transcutaneous bilirubin (TcB) and serum bilirubin (SBR) results were compared using linear regression and a Bland-Altman plot. Predicted indices were calculated to assess the KJ-8000 as a screening tool using local jaundice management guidelines.
A total of 416 paired samples were collected from 201 infants. There was a strong correlation between TcB and SBR with a Pearson correlation coefficient of 0.8 (<0.00001). The bias was -5.9 μmol/L (95% confidence interval: -101, 89). The bias was not evenly spread, with the KJ-8000 tending to underestimate at higher SBR levels. Infants <32 weeks' gestation had a poor correlation of 0.48. Non-Caucasian infants were more likely to have TcB overestimation, and measurements were less precise. As a screening tool using local guidelines, the KJ-8000 had a sensitivity, specificity, positive predictive value and negative predictive value of 83, 53, 20 and 96%, respectively, and is predicted to avoid blood tests in 48% of infants screened.
In this study, the correlation and agreement of TcB measurements using the KJ-8000 were not as good as has been reported with other more studied devices but may still have value as a screening tool. The poor correlation in preterm infants suggests that use should be restricted to term infants. The overall results of this study are affected by an underrepresentation of term infants, and so, further clinical assessment of this device should be undertaken before it can be recommended for widespread use.
评估科健8000（KJ - 8000）经皮胆红素仪在不同种族和胎龄婴儿中的准确性。
这是一项对黄金海岸大学医院新生儿护理单元婴儿的前瞻性研究。使用线性回归和布兰德 - 奥特曼图比较经皮胆红素（TcB）和血清胆红素（SBR）结果。根据当地黄疸管理指南计算预测指标，以评估KJ - 8000作为筛查工具的情况。
共从201名婴儿中收集了416对样本。TcB和SBR之间存在强相关性，皮尔逊相关系数为0.8（<0.00001）。偏差为 - 5.9 μmol/L（95%置信区间： - 101, 89）。偏差分布不均匀，KJ - 8000在较高SBR水平时往往低估。孕周<32周的婴儿相关性较差，为0.48。非白种人婴儿的TcB更可能被高估，且测量精度较低。作为使用当地指南的筛查工具，KJ - 8000的灵敏度、特异度、阳性预测值和阴性预测值分别为83%、53%、20%和96%，预计在48%的筛查婴儿中可避免进行血液检测。
在本研究中，使用KJ - 8000进行TcB测量的相关性和一致性不如其他研究较多的设备所报道的那样好，但作为筛查工具可能仍有价值。早产儿相关性较差表明应仅限于足月儿使用。本研究的总体结果受足月儿代表性不足的影响，因此，在推荐该设备广泛使用之前，应进行进一步的临床评估。
