黄疸指数在总胆红素检验申请管理中的应用

The Use of the Icteric Index in the Management of Total Bilirubin Test Requests

目的评估黄疸指数(icteric index,Ⅱ)作为高胆红素血症(总胆红素浓度>17.1μmol/L,>1mg/dL)筛查生物标志物的临床实用性和经济效益。方法回顾性分析2021年1月至12月全部患者的总胆红素(total bilirubin,TBIL)和黄疸指数结果,基于Spearman相关性分析、Deming(戴明)回归分析、Bland-Altman一致性分析比较总胆红素和黄疸指数的一致性,采用受试者工作特征(receiver operating characteristic,ROC)曲线分析评估黄疸指数预测高胆红素血症的诊断准确性。为验证研究结果,在单独人群中采用相同方法进行为期2个月的前瞻性研究(2022年1月至2月)。结果本研究包括21413例患者的总胆红素和黄疸指数结果。总胆红素和黄疸指数高度相关且存在一致性。ROC曲线分析显示2mg/dL(34.2μmol/L)为预测高胆红素血症的最佳黄疸指数阈值,曲线下的面积(area under the curve,AUC)为0.997。各就诊类型(门诊、住院、急诊)标本灵敏度均大于97%,特异性均为100%。经济效益分析显示采用2mg/dL(34.2μmol/L)黄疸指数阈值,实验室能够节省91.88%的总胆红素测试,并在未要求总胆红素测试的标本中分析出0.44%的阳性结果,节约经费97740元。结论本研究支持采用黄疸指数改善总胆红素检验申请,这一策略的临床应用仍需进一步探讨。

Objective To assess the clinical utility and economic benefits of the icteric index(Ⅱ) as a screening biomarker for hyperbilirubinemia(total bilirubin concentration >17.1μmol/L, >1mg/dL).Methods A retrospective analysis was conducted for total bilirubin(TBIL) and icteric index results of all patients from January to December, 2021, based on Spearman’s rank correlation analysis, Deming regression analysis, Bland-Altman plot analysis to compare the consistency of total bilirubin and icteric index. The diagnostic accuracy of the icteric index in predicting hyperbilirubinemia was assessed using the receiver operating characteristic(ROC) curve analysis. To validate the findings, we conducted a 2-month prospective study(January-February, 2022) in a separate study cohort using the same methodology.Results This study included total bilirubin and icteric index results from 21 413 patients. Total bilirubin and icteric indices were highly correlated and consistent. ROC curve showed that 2 mg/dL(34.2μmol/L) was the optimal icteric index threshold for predicting hyperbilirubinemia, with an area under the curve(AUC) of 0.997. The sensitivity of the specimens was >97%, and the specificity was 100% for all visit types(outpatient, inpatient, emergency). The economic benefit analysis showed that by using the 2mg/dL(34.2μmol/L) icteric index threshold, the laboratory was able to save 91.88% of total bilirubin tests and analyze 0.44% of positive results in specimens not required for total bilirubin testing, resulting in a savings of 97 740￥.Conclusion This study supports the application of the icteric index to improve total bilirubin test requests, a strategy that could improve clinical laboratory efficiency.