The SFBC-CNBH-CNRHP "Neonatal bilirubin" working group performed a biological and clinical study on bilirubin use in neonates for reliable diagnosis and appropriate management of neonatal jaundice. A brief report of a national survey on analytical and biological practices in France is shown. The guidelines of the French Society of Neonatology (SFN) founded the decision of phototherapy set up upon an accurate lab measurement of total serum bilirubin. An abacus is proposed with defined thresholds, as a function of neonate lifetime in hours. However, several studies evidenced poor comparability of results obtained with the different available methods. This situation is partly due to the lack of reference materials, especially for high bilirubin concentrations. Clinical consequences might be observed. We present in this paper the results of a national harmonization study to progress on this issue. Beyond the analytical aspects, the clinical consequences of harmonization defects were investigated. Finally, guidelines for clinical laboratories are proposed, to be locally adapted.
Keywords: clinical impact; guidelines; harmonization; neonates; standardization; total bilirubin.