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Assessment of bilirubin assays enhances clinical decision-making in neonatal jaundice, emphasizing rigorous standards.
Insufficient standardization and comparability of total bilirubin assays in neonates pose a problem for the interpretation of results, in application of national and international recommendations for the management of neonatal ejaundice. We present the results of a study carried out in the AP-HP Sorbonne Université group. Intra-laboratory and inter-technique variations were assessed on switchable control samples prepared by the Centre National de Référence en Hémobiologie Périnatale. Results were compared with those obtained using the connected validation technique. The results of the accuracy studies showed performance in line with clinical needs in neonatology for all the methods tested. Accuracy studies were used to check whether the clinical interpretation of results was relevant to consensus criteria. The results confirmed the trends observed in a national multicenter SFBC (Société Française de Biologie Clinique) - CNBH (Collège National de Biochimie des Hôpitaux) - CNRHP (Centre National de Référence en Hémobiologie Périnatale) study and in the CNRHP recommendations on the subject. In conclusion, a good knowledge by the medical biologist of the recommended criteria for interpretation and therapeutic decisions, of the limits and performance of the techniques used, and a close clinicobiological partnership are essential for optimum efficiency in the management of neonatal jaundice.
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Mailloux et al. (2025) studied this question.
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