Background: Management of jaundiced newborns often requires measurement of total serum bilirubin (TSB). Past studies of the inter- and intra-instrument and hospital variability of bilirubin analyses have shown significant discrepancies. Objective: To compare the accuracy and bias of various contemporary clinical laboratory neonatal TSB methods against HPLC analysis, the “gold standard”. Methods: Serum samples were obtained from 206 newborns at PAH by heel stick. A 50 μL sample was aliquoted into an amber tube, frozen at -70°C and analyzed by HPLC and Ektachem within two weeks at UW. TSB was measured at PAH by Hitachi 911 (Diazo reaction), American Optical (direct spectrophotometric method), UB Analyzer (White method) or Ektachem DT60 (Vitros NBIL slides). All samples were analyzed with HPLC and as many other methods as serum volume permitted. Results: Correlation of each method with HPLC was similar(r≅0.98). The Ektachem had the largest Root Mean Square Error (RMSE)(p=0.0000), Standard Error of the Estimate (SE-y), and regression equation intercept. RMSE of the other methods did not differ (p>0.5), but the intercept was significant in two methods. Conclusion: Although current TSB methods in our laboratories show high correlation with HPLC, there are significant differences. In assessing the accuracy of non-invasive methods to measure TSB, data must include HPLC and multiple clinical methods. Table

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