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Editorial |

Laboratory Accuracy in Neonatal Bilirubin The Search for Truth in Laboratory Medicine

Stanley F. Lo, PhD1,2
[+] Author Affiliations
1Department of Pathology, Medical College of Wisconsin, Milwaukee
2Department of Pathology and Laboratory Medicine, Children’s Hospital of Wisconsin, Milwaukee
JAMA Pediatr. 2016;170(6):529-530. doi:10.1001/jamapediatrics.2016.0279.
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In this issue of JAMA Pediatrics, Kuzniewicz et al1 describe the consequences of an in vitro diagnostics manufacturer altering the values assigned to their calibrators for the determination of neonatal bilirubin concentrations. Notable in the study are the sizes of the prerecalibration population (n = 61 945) and postrecalibration group (n = 47 359). This significantly large number of newborn samples was evaluated for exceeding the American Academy of Pediatrics phototherapy threshold and the effect on phototherapy of newborns during their birth hospitalization and its effect on readmission for phototherapy. The postrecalibration resulted in patient bilirubin levels decreasing by 1.18 mg/dL (to convert to micromoles per liter, multiply by 17.1) and consequently decreasing the number of infants above the American Academy of Pediatrics phototherapy threshold. Changes to bilirubin assays are not limited to reassigning values to calibrators. Changes to different manufactured lots of reagents is very common, while changing to an alternate bilirubin assay is uncommon.2 Even instrumentation changes may result in new bilirubin assays that may occur more frequently owing to the consolidation of health systems and the need for clinical laboratories to standardize their instrumentation.

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Bilirubin, an assay more precise than the interpretation
Posted on April 23, 2016
Kenneth Harkavy
Reston Hospital Center
Conflict of Interest: None Declared
A precision on the order of a few percent is more than in the past, so I for one am grateful. Is a new assay that \"underestimates\" the serum bilirubin by 1.18mg% of concern? Should it require a change in the position of the treatment curves, whether published by the AAP or the NICE (National Institute for Health and Care and Excellence https://www.nice.org.uk/)? There are precious little data from randomized trials about safe levels of bilirubin. What is agreed upon is based on population data, case studies and personal opinion. Exchange levels are usually 5mg% above phototherapy levels, providing the first margin of safety. Exchange levels are typically below levels associated with encephalopathy, providing another safety margin. In fact, in my experience referral NICU's rarely if ever perform an exchange, even when levels exceed guidelines.

I conclude that the new lower values are a blessing: fewer infants treated.
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