Lecture
Neonatal Bilirubin - different assays, different results? Status of standardization
- at -
- ICM Saal 4a
- Type: Lecture
Lecture description
Accurate measurement of total bilirubin (TBil) is critical for diagnosing and managing neonatal hyperbilirubinemia. Despite long-standing efforts toward standardization, significant discrepancies of 10–20 % persist between commercial assays, posing a direct risk to patient care. This presentation explores the key sources of this variability, including differing measurement principles, calibration challenges (bovine vs. human sources), a lack of commutability in control materials, and matrix effects specific to neonatal samples.
While a reference system exists—comprising a NIST standard and two JCTLM-listed reference measurement procedures (RMPs)—its implementation is incomplete. The proficiency testing material used (RELA) is based on an adult matrix, and only three JCTLM reference services are available worldwide. Consequently, manufacturers follow different traceability routes, and clinical laboratories use less standardized procedures. As recently highlighted by the IFCC Working Group on Neonatal Bilirubin (WG-NB), this fragmented approach undermines the goal of measurement equivalence.
The clinical implications are severe, ranging from unnecessary phototherapy to missed diagnoses requiring urgent intervention. This presentation argues that achieving reliable and equivalent TBil results requires a concerted effort to address weaknesses at every stage of the traceability hierarchy, from reference materials to routine clinical practice.
While a reference system exists—comprising a NIST standard and two JCTLM-listed reference measurement procedures (RMPs)—its implementation is incomplete. The proficiency testing material used (RELA) is based on an adult matrix, and only three JCTLM reference services are available worldwide. Consequently, manufacturers follow different traceability routes, and clinical laboratories use less standardized procedures. As recently highlighted by the IFCC Working Group on Neonatal Bilirubin (WG-NB), this fragmented approach undermines the goal of measurement equivalence.
The clinical implications are severe, ranging from unnecessary phototherapy to missed diagnoses requiring urgent intervention. This presentation argues that achieving reliable and equivalent TBil results requires a concerted effort to address weaknesses at every stage of the traceability hierarchy, from reference materials to routine clinical practice.
