Assessment of Neonatal Hyperbilirubinemia Using GEM Premier 4000 Total Bilirubin Assay: Impact on Risk Classification?

In this study, we evaluated the correlation of whole blood TBili results measured on a blood gas analyzer to serum results obtained on an automated chemistry analyzer. In addition, we determined the concordance of hyperbilirubinemia risk classification between the 2 methods. Seventy-nine blood samples were collected. The TBili (mg/dL) was measured on whole blood using the Instrumentation Laboratories GEM 4000 (GEM) and on simultaneously collected serum samples on the Siemens Dimension Vista chemistry analyzer (Vista). Twenty-four infants, aged younger than 7 days, were classified into categories for risk of sequelae of severe hyperbilirubinemia using an established postnatal hour-specific nomogram. GEM results showed a mean bias of +0.55 mg/dL compared with Vista. Eight (33%) of 24 infants were assigned different risk grades by the GEM; 4 were assigned higher risk grades, and 4 had lower risk grades; only 1 infant’s risk status was changed by more than 1 grade. Therefore, although the GEM method shows good overall agreement with the Vista chemistry analyzer in measurement of TBili levels, assignment of clinical risk categories may differ by the 2 methods.
Source: Point of Care: The Journal of Near-Patient Testing and Technology - Category: Pathology Tags: Original Articles Source Type: research