A Significant Increase in the Incidence of Neonatal Hyperbilirubinemia and Phototherapy Treatment Due to a Routine Change in Laboratory Equipment.

IF 3.7 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY
Marlies Oostendorp, Christine H Ten Hove, Miranda van Berkel, Lian Roovers
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Abstract

Context.—: Total serum bilirubin (TSB) analysis is pivotal for diagnosing neonatal hyperbilirubinemia. Because of a routine change in laboratory equipment, our TSB assay changed from a diazo to a vanadate oxidase method. Upon implementation, TSB results were substantially higher in newborns than expected based on the validation.

Objective.—: To investigate the application of TSB and intermethod differences in neonates and their impact on phototherapy treatment.

Design.—: The diazo and vanadate methods were compared directly using neonatal and adult samples. Anonymized external quality control data were analyzed to explore interlaboratory differences among 8 commercial TSB assays. Clinical patient data were extracted from the medical records to investigate the number of newborns receiving phototherapy.

Results.—: The mean bias of the vanadate versus the diazo TSB method was +17.4% and +3.7% in neonatal and adult samples, respectively. External quality control data showed that the bias of commercial TSB methods compared with the reference method varied from -3.6% to +20.2%. Within-method variation ranged from 5.2% to 16.0%. After implementation of the vanadate TSB method, the number of neonates treated with phototherapy increased approximately threefold.

Conclusions.—: Currently available TSB assays lack harmonization for the diagnosis of neonatal hyperbilirubinemia. Between-methods differences are substantially higher in neonatal compared with adult samples, highlighting the importance of including neonatal samples during assay validation. Close collaboration between laboratory specialists and clinicians is essential to prevent overtreatment or undertreatment upon the implementation of novel analyzers or assays. Also, harmonization of TSB assays, with an emphasis on neonatal application, is warranted.

实验室设备的例行更换导致新生儿高胆红素血症发病率和光疗治疗显著增加。
背景血清总胆红素(TSB)分析是诊断新生儿高胆红素血症的关键。由于实验室设备的例行更换,我们的 TSB 检测方法从重氮法改为钒酸盐氧化酶法。实施该方法后,新生儿的 TSB 检测结果大大高于基于验证的预期结果:调查 TSB 在新生儿中的应用和方法间差异及其对光疗治疗的影响:设计:使用新生儿和成人样本直接比较重氮法和钒酸盐法。分析了匿名外部质量控制数据,以探讨 8 种商用 TSB 检测方法的实验室间差异。从医疗记录中提取了临床患者数据,以调查接受光疗的新生儿数量:在新生儿和成人样本中,钒酸盐法与重氮 TSB 法的平均偏差分别为 +17.4% 和 +3.7%。外部质量控制数据显示,商用 TSB 方法与参比方法相比,偏差从 -3.6% 到 +20.2% 不等。方法内变异从 5.2% 到 16.0% 不等。采用钒酸盐 TSB 方法后,接受光疗的新生儿人数增加了约三倍:结论:目前可用的 TSB 检测方法在诊断新生儿高胆红素血症方面缺乏统一性。与成人样本相比,新生儿样本的检测方法之间的差异要大得多,这突出了在检测方法验证过程中加入新生儿样本的重要性。实验室专家和临床医生之间的密切协作对于防止在使用新型分析仪或检测方法时出现过度治疗或治疗不足至关重要。此外,有必要统一 TSB 检测方法,重点关注新生儿的应用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
9.20
自引率
2.20%
发文量
369
审稿时长
3-8 weeks
期刊介绍: Welcome to the website of the Archives of Pathology & Laboratory Medicine (APLM). This monthly, peer-reviewed journal of the College of American Pathologists offers global reach and highest measured readership among pathology journals. Published since 1926, ARCHIVES was voted in 2009 the only pathology journal among the top 100 most influential journals of the past 100 years by the BioMedical and Life Sciences Division of the Special Libraries Association. Online access to the full-text and PDF files of APLM articles is free.
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