Borgard Jean-Pierre, Szymanowicz Anton, Pellae Isabelle, Szmidt-Adjidé Valérie, Rota Michèle
Biochemistry Laboratory, Centre Hospitalier Intercommunal de Créteil, Créteil, France.
Clin Chem Lab Med. 2006;44(9):1103-10. doi: 10.1515/CCLM.2006.202.
Jaundice is frequent in neonates and can cause severe complications, especially in premature neonates, particularly the risk of developing acute bilirubin encephalopathy. Our purpose was to verify if determination of total bilirubin (TBIL) in whole blood on an ABL 735 blood gas analyzer with a spectrophotometer module could provide an analytical alternative to chemical methods of TBIL measurement.
Our multicenter comparative study involved four hospital laboratories. We studied the repeatability and reproducibility of ABL 735 TBIL measurements in two control sera of medium (N1, 58.1 micromol/L) and high (N2, 275.3 micromol/L) TBIL levels. The same study was simultaneously conducted on four chemistry instruments (two LX 20, one Integra 800 and one Hitachi 917) using four Jendrassik-Grof derived methods. At one site, repeatability was performed with two adult whole-blood samples containing low and high TBIL levels (55.1 and 312.6 micromol/L).
Repeatability tests provided coefficients of variation (CVs) between 0.67% and 1.86% on the ABL 735 system, vs. 0.35% and 1.96% for the chemistry instruments. Reproducibility tests for the same control sera resulted in CVs between 1.01% and 3.55% for the ABL 735 and between 0.52% and 3.65% for the chemistry instruments. Recovery for the N1 and N2 control sera was 102-120%. A correlation study of TBIL determination in whole blood vs. plasma was conducted on 473 neonatal blood samples. Correlation coefficients between whole blood and plasma TBIL ranged from 0.969 to 0.994. Passing-Bablok equations were y=1.17x+9.7 [site 1 (IP)], y=1.01x+5.6 [site 2 (JPB, MR)], and y=1.00x-20 [site 3 (AS)]. Only 10% of the results fell outside the 10% range in the bias-corrected Bland-Altman difference plot for the ABL 735 method compared to traditional laboratory methods.
The ABL 735 instrument is reliable for measuring TBIL in 70-microL whole blood samples from neonates. Thus, this method might allow significant blood savings in preterm neonates. Correlation with the reference method for plasma or sera must be established to ensure good follow-up of patients.
黄疸在新生儿中很常见，可导致严重并发症，尤其是早产儿，特别是发生急性胆红素脑病的风险。我们的目的是验证使用带有分光光度计模块的ABL 735血气分析仪测定全血总胆红素（TBIL）是否可以为TBIL测量的化学方法提供一种分析替代方法。
我们的多中心比较研究涉及四个医院实验室。我们研究了在两种中等（N1，58.1微摩尔/升）和高（N2，275.3微摩尔/升）TBIL水平的对照血清中ABL 735 TBIL测量的重复性和再现性。同时使用四种Jendrassik-Grof衍生方法在四台化学分析仪（两台LX 20、一台Integra 800和一台日立917）上进行相同的研究。在一个地点，使用两份含有低和高TBIL水平（55.1和312.6微摩尔/升）的成人全血样本进行重复性测试。
重复性测试在ABL 735系统上提供的变异系数（CV）在0.67%至1.86%之间，而化学分析仪为0.35%至1.96%。相同对照血清的再现性测试结果显示，ABL 735的CV在1.01%至3.55%之间，化学分析仪在0.52%至3.65%之间。N1和N2对照血清的回收率为102 - 120%。对473份新生儿血样进行了全血与血浆中TBIL测定的相关性研究。全血与血浆TBIL之间的相关系数范围为0.969至0.994。通过 - Bablok方程为y = 1.17x + 9.7 [地点1（IP）]，y = 1.01x + 5.6 [地点2（JPB，MR）]，以及y = 1.00x - 20 [地点3（AS）]。与传统实验室方法相比，ABL 735方法的偏差校正Bland - Altman差异图中只有10%的结果落在10%范围之外。
ABL 735仪器用于测量新生儿70微升全血样本中的TBIL是可靠的。因此，这种方法可能在早产儿中显著节省血液。必须建立与血浆或血清参考方法的相关性，以确保对患者进行良好的随访。
