探讨智能手机程序自动拍照检测胆红素(AIB)浓度在新生儿黄疸患儿中的应用价值。

选取2018年1至12月，唐山市妇幼保健院收治的300例新生儿黄疸患儿为研究对象。对其采取以下3种方法测新生儿胆红素浓度：①采集肘静脉血测定血清总胆红素(TSB)浓度；②采用经皮黄疸测试仪测定经皮胆红素(TcB)浓度；③采用智能手机程序AIB浓度。对其AIB与TSB浓度、TcB与TSB浓度比较，采用配对t检验。采用Bland-Altman一致性检验对3种方法检测新生儿胆红素浓度的AIB与TSB浓度、TcB与TSB浓度一致性进行分析，再采用直线相关分析对其中2种方法的检测结果进行相关性分析。本研究得到唐山市妇幼保健院伦理委员会批准(伦理第202002901)，并且与受试者签署临床研究知情同意书。

① 300例患儿的TSB、TcB和AIB浓度分别为(192.2±66.5) μmol/L、(195.3±70.2) μmol/L和(198.7±52.6) μmol/L，其AIB和TSB浓度、TcB和TSB浓度分别比较，差异均无统计学意义(t＝1.333、0.564，P＝0.182、0.586)。Bland-Altman一致性检验结果提示，检测新生儿AIB与TSB、TcB与TSB浓度均具有较强一致性[96.0%(288/300)、97.0%(291/300)]。新生儿AIB与TSB、TcB与TSB浓度均呈正相关关系(r＝0.601、0.783，P＝0.024、0.018)。②胎龄>35周患儿AIB和TcB与TSB浓度比较，差异均无统计学意义(t＝0.041、0.188，P＝0.974、0.867)；胎龄<35周患儿TcB与TSB浓度比较，差异无统计学意义(t＝1.385，P＝0.175)，AIB和TSB浓度比较，差异有统计学意义(t＝2.931，P＝0.002)。不同胎龄、不同日龄新生儿AIB与TSB、TcB与TSB浓度均有较强的一致性。③受试者工作特征(ROC)曲线分析结果显示，本组新生儿AIB、TcB浓度的曲线下面积(AUC)分别为0.693(95%CI：0.614～0.723，P＝0.014)和0.690(95%CI：0.604～0.776，P＝0.027)。根据约登指数最大原则，AIB浓度的最佳临界值为193.247 μmol/L时，对于诊断新生儿黄疸患儿的敏感度为68.7%，特异度为67.4%；TcB浓度最佳临界值为189.348 μmol/L时，敏感度为75.0%，特异度为71.2%。

本组新生儿AIB和TcB与TSB浓度均具有良好的一致性，对诊断新生儿黄疸具有较高敏感度和特异度。智能手机程序因其无创，而更容易被出院后需进行胆红素浓度检测的随访患儿接受。

To explore the application value of automated image-based bilirubin (AIB) detection by smartphone application in neonates with jaundice.

From January to December, 2018, a total of 300 neonates with jaundice were selected into this study. Venous blood was collected from all children to determine serum total bilirubin (TSB) concentration, transcutaneous jaundice tester was used to determine the transcutaneous bilirubin (TcB) concentration, and smartphone application program was used to automatically take pictures to detect the AIB concentration. Paired t test was used to compare the concentrations of AIB and TSB, TcB and TSB in neonates with jaundice. The Bland-Altman consistency test was used to analyze the consistency between different methods, and then the linear correlation analysis was used to analyze the correlation between two detection methods. The procedures followed in this study were in accordance with the standards established by the Committee of Investigation in Human Beings of Tangshan Maternal and Children Health Hospital, and this study was approved by the committee (Approval No. 202002901). Informed consent was obtained from each participates′ guardians.

①The concentrations of TSB, TcB and AIB of 300 children were (192.2±66.5) μmol/L, (195.3± 70.2) μmol/L and (198.7±52.6) μmol/L, respectively. There were no significant differences between the concentrations of AIB and TSB, TcB and TSB, respectively (t=1.333, 0.564, P=0.182, 0.586). The Bland-Altman consistency test results showed that AIB and TSB, TcB and TSB had strong consistency [96.0% (288/300), 97.0% (291/300)]. Linear correlation analysis between AIB and TSB, TcB and TSB showed positive correlation, respectively (r=0.601, 0.783, P=0.024, 0.018). ② There were no statistically significant differences between AIB and TSB, between TcB and TSB of children with gestational age>35 weeks (t=0.041, 0.188, P=0.974, 0.867); there was no significant difference between TcB and TSB in children with gestational age<35 weeks (t=1.385, P=0.175), but there was significant difference between AIB and TSB (t=2.931, P=0.002). There were strong consistency between AIB and TSB, TcB and TSB in neonates with jaundice at different gestational age and different age. ③ Receiver operating characteristics (ROC) curve analysis showed the following. The area under curve (AUC) of AIB and TcB for serum bilirubin levels were 0.693 (95%CI: 0.614-0.723, P=0.014) and 0.690 (95%CI: 0.604-0.776, P=0.027), respectively. According to the principle of maximum Youden index, the optimal critical value of serum bilirubin level determined by AIB was 193.247 μmol/L, and the sensitivity and specificity was 68.7% and 67.4%, respectively. The optimal critical value for the determination of serum bilirubin by TcB was 189.348 μmol/L, and the sensitivity was 75.0% and the specificity was 71.2%.

Both AIB and TcB have good consistency with TSB, and have high sensitivity and specificity. Smartphone applications are more suitable for children with jaundice who need follow-up after discharge.