Neonatal total bilirubin measurements: Still room for harmonization

Clin Biochem. 2014 Aug;47(12):1112-5. doi: 10.1016/j.clinbiochem.2014.04.001. Epub 2014 Apr 13.

Abstract

Background: Universal screening of total bilirubin in neonates is endorsed by experts from the American Academy of Pediatrics and is increasingly common. Methodological differences between diazo-based quantitation ("wet" chemistry) and reflectance spectrophotometric quantitation ("dry" chemistry) can lead to unnecessary treatment. A recent recalibration of the only commercially available "dry" chemistry assay was issued to reduce these differences. This study evaluated the post-recalibration bias between the two assay types.

Methods: Method comparison of neonatal total bilirubin (Beckman AU680 vs Ortho-Clinical-Diagnostics Vitros) was achieved using freshly-drawn neonatal samples (n=239).

Results: The Vitros produced neonatal bilirubin results with a 12.4% average positive bias compared to the AU680 total bilirubin results. The AU680 direct bilirubin reaction had 5.6% cross reactivity with unconjugated bilirubin.

Conclusions: Neonatal or total bilirubin quantitation remains unharmonized between platforms. Care should be taken to understand the bias of specific platforms.

Keywords: AU680; Neonatal hyperbilirubinemia; Total and direct bilirubin; Universal screening; Vitros.

MeSH terms

  • Bilirubin / blood*
  • Humans
  • Infant, Newborn

Substances

  • Bilirubin