Dina N Greene1, Joy Liang2, Daniel T Holmes3, Ann Resch2, Thomas S Lorey2. 1. Kaiser Permanente, TPMG Northern California Regional Laboratory, Berkeley, CA, USA. Electronic address: dina.n.greene@kp.org. 2. Kaiser Permanente, TPMG Northern California Regional Laboratory, Berkeley, CA, USA. 3. University of British Columbia, Department of Pathology and Laboratory Medicine, Vancouver, BC, Canada.
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.
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.
Authors: Christian V Hulzebos; Libor Vitek; Carlos D Coda Zabetta; Aleš Dvořák; Paul Schenk; Eline A E van der Hagen; Christa Cobbaert; Claudio Tiribelli Journal: Pediatr Res Date: 2021-05-04 Impact factor: 3.756