Bilirubin measurements in neonates: uniform neonatal treatment can only be achieved by improved standardization

Author:

Hulzebos Christian V.1ORCID,Camara Johanna E.2ORCID,van Berkel Miranda3ORCID,Delatour Vincent4ORCID,Lo Stanley F.5,Mailloux Agnès6,Schmidt Marcel C.7,Thomas Mercy8910ORCID,Mackay Lindsey G.11ORCID,Greaves Ronda F.1213ORCID

Affiliation:

1. Department of Paediatrics, Division of Neonatology, Beatrix Children’s Hospital, University Medical Center Groningen , Groningen , The Netherlands

2. Chemical Sciences Division , National Institute of Standards and Technology (NIST) , Gaithersburg , MD , USA

3. Department of Laboratory Medicine , Radboud University Medical Centre , Nijmegen , The Netherlands

4. Laboratoire National de Métrologie et d’Essais (LNE) , Paris , France

5. Department of Pathology and Laboratory Medicine , Children’s Wisconsin and Medical College of Wisconsin , Milwaukee , WI , USA

6. Centre National de Référence en Hémobiologie Périnatale, Unit of Biologie, Pole Biology, Hopital Saint Antoine (Public Assistance Hospitals of Paris (AP-HP)) , Paris , France

7. Roche Diagnostics GmbH , Penzberg , Germany

8. The Royal Children’s Hospital , Parkville , VIC , Australia

9. Murdoch Children’s Research Institute , Parkville , VIC , Australia

10. School of Health Sciences, Swinburne University of Technology , Melbourne , VIC , Australia

11. National Measurement Institute , Sydney , NSW , Australia

12. Victorian Clinical Genetics Services, Murdoch Children’s Research Institute , Parkville , VIC , Australia

13. Department of Paediatrics , University of Melbourne , Parkville , VIC , Australia

Abstract

Abstract Measurement of total bilirubin (TBil) concentration in serum is the gold standard approach for diagnosing neonatal unconjugated hyperbilirubinemia. It is of utmost importance that the measured TBil concentration is sufficiently accurate to prevent under treatment, unnecessary escalation of care, or overtreatment. However, it is widely recognized that TBil measurements urgently require improvement in neonatal clinical chemistry. External quality assessment (EQA) programs for TBil assess for differences between laboratories and provide supporting evidence of significant differences between various methods, manufacturers and measurement platforms. At the same time, many countries have adopted or only slightly adapted the neonatal hyperbilirubinemia management guidelines from the USA or UK, often without addressing differences in the methodology of TBil measurements. In this report, we provide an overview of the components of bilirubin that are measured by laboratory platforms, the availability of current reference measurement procedures and reference materials, and the role of EQA surveys in this context. Furthermore, the current status of agreement in neonatal bilirubin against clinical decision thresholds is reviewed. We advocate for enhancements in accuracy and comparability of neonatal TBil measurements, propose a path forward to accomplish this, and reflect on the position of the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC) Working Group Neonatal Bilirubin (WG-NB) in this matter.

Publisher

Walter de Gruyter GmbH

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