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

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Abstract

Measurement of total serum bilirubin (TSB) concentration is the gold standard approach for diagnosing neonatal unconjugated hyperbilirubinemia. It is of utmost importance that the measured TSB concentration is sufficiently accurate to prevent undertreatment, unnecessary escalation of care, or overtreatment. However, it is widely recognized that TSB measurements urgently require improvement in neonatal clinical chemistry. External quality assessment (EQA) programs for TSB 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 TSB measurements. In this report, we provide an overview of the current status of agreement in neonatal bilirubin against clinical decision thresholds, the availability of current reference measurement procedures and reference materials, and the role of EQA surveys in this context. We advocate for enhancements in accuracy and comparability of neonatal TSB 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.

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Keywords

Health, Clinical diagnostics, Chemistry and Analytical chemistry

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