Wang Qing, Zhang Tianyi, Lin Yuanxi, Jiang Li, Zhou Wenlong, Zong Xiaolong
Department of Clinical Laboratory, The General Hospital of Tianjin Medical University, Tianjin, China.
Department of Emergency Medicine, The Second Hospital of Tianjin Medical University, Tianjin, China.
Front Pediatr. 2022 Jul 4;10:910566. doi: 10.3389/fped.2022.910566. eCollection 2022.
Accurate bilirubin measurements are essential for appropriate management of neonatal hyperbilirubinemia. This study aimed to evaluate the accuracy and reliability of whole blood bilirubin measurements obtained using a Roche blood gas analyzer (Roche TBiL), with total serum bilirubin (TSB) measurements determined by the Ortho VITROS 4600 chemistry system (Ortho TSB) serving as a reference.
Medical records of hospitalized neonates that underwent simultaneous Roche TBiL and Ortho TSB measurements were reviewed for eligibility selection and data collection. The correlations and differences between two sets of results were determined using Passing-Bablok regression analysis and a Bland-Altman plot, respectively. For eligible newborns, the risk of developing severe hyperbilirubinemia was assessed using the Bhutani nomogram. Weighted kappa analysis was used to evaluate the agreement between risk prediction by the two methods.
We obtained 618 paired Roche TBiL and Ortho TSB results from 309 neonates. Roche TBiL and Ortho TSB measurements showed a good correlation ( = 0.923; 95% CI: 0.905-0.938). Passing-Bablok regression analysis yielded the following equation: Roche TBiL = 0.794 × Ortho TSB + 1.255 mg/dL, with a slope of 0.794 (95% CI: 0.763-0.825) and intercept of 1.255 (95% CI: 1.042-1.417). The average difference between the two methods was 0.1 ± 1.448 mg/dL. A total of 207 neonates were eligible for evaluation of the agreement between the risk-grading methods. Although kappa analysis showed good agreement between the methods, with a weighted kappa of 0.681 (95% CI: 0.610-0.751) across all populations, the values for approximately half of the neonates at intermediate and high risk of hyperbilirubinemia (33/72) were underestimated by Roche TBiL.
Our results indicate that Roche TBiL and Ortho TSB measurements in the neonatal population are not consistent. As a point-of-care and trace blood assay, Roche blood gas bilirubin measurements can facilitate primary screening of neonatal hyperbilirubinemia, but it seems to lack accuracy regarding risk stratification, particularly for high-risk newborn individuals.
准确测量胆红素对于新生儿高胆红素血症的合理管理至关重要。本研究旨在评估使用罗氏血气分析仪（Roche TBiL）进行的全血胆红素测量的准确性和可靠性，以奥森VITROS 4600化学系统测定的总血清胆红素（TSB）测量值（Ortho TSB）作为参考。
回顾了同时进行罗氏TBiL和奥森TSB测量的住院新生儿的病历，以进行合格性筛选和数据收集。分别使用Passing-Bablok回归分析和Bland-Altman图确定两组结果之间的相关性和差异。对于符合条件的新生儿，使用布塔尼列线图评估发生重度高胆红素血症的风险。加权kappa分析用于评估两种方法在风险预测方面的一致性。
我们从309名新生儿中获得了618对罗氏TBiL和奥森TSB结果。罗氏TBiL和奥森TSB测量结果显示出良好的相关性（r = 0.923；95%CI：0.905 - 0.938）。Passing-Bablok回归分析得出以下方程：罗氏TBiL = 0.794×奥森TSB + 1.255mg/dL，斜率为0.794（95%CI：0.763 - 0.825），截距为1.255（95%CI：1.042 - 1.417）。两种方法之间的平均差异为0.1±1.448mg/dL。共有207名新生儿符合评估风险分级方法之间一致性的条件。尽管kappa分析显示两种方法之间具有良好的一致性，所有人群加权kappa为0.681（95%CI：0.610 - 0.751），但罗氏TBiL对大约一半处于中度和高度高胆红素血症风险的新生儿（33/72）的值进行了低估。
我们的结果表明，新生儿群体中罗氏TBiL和奥森TSB测量结果不一致。作为一种即时检测和微量血检测方法，罗氏血气胆红素测量可促进新生儿高胆红素血症的初步筛查，但在风险分层方面似乎缺乏准确性，尤其是对于高危新生儿个体。
