Error simulation modeling to assess the effects of bias and precision on bilirubin measurements used to screen for neonatal hyperbilirubinemia.

Objectives: Error simulation models have been used to understand the relationship between analytical performance and clinical outcomes. We developed an error simulation model to understand the effects of method bias and precision on misclassification rate for neonatal hyperbilirubinemia using an age-adjusted risk assessment tool.

Methods: For each of 176 measured total bilirubin (TSB) values, 10,000 simulated total bilirubin (TB) values were generated at each combination of bias and precision conditions for coefficient of variation (CV) between 1 and 15%, and for biases between -51.

Implementation of a reformulated Roche® bilirubin Gen.3 reagent did not affect the relationship between BiliChek transcutaneous and Roche total serum bilirubin.

Objective: Determine whether introduction of a reformulated bilirubin reagent, the Roche bilirubin Gen.3 assay, changed the relationship between BiliChek transcutaneous bilirubin (TcB) and total serum bilirubin (TSB).

Design And Methods: TcB results from term infants in the level 1 nursery obtained within one hour of a TSB were reviewed over two periods, six months before and after the conversion from the previous generation Roche bilirubin reagent to the new Roche Gen.

Accuracy of neonatal transcutaneous bilirubin measurement in the outpatient setting.

OBJECTIVE. To evaluate the effectiveness of transcutaneous bilirubin (TcB) measurement in predicting risk for neonatal hyperbilirubinemia in outpatients. DESIGN.

BiliChek transcutaneous bilirubin meter overestimates serum bilirubin as measured by the Doumas reference method.

Objectives: To determine the relationship between BiliChek TcB (Respironics, Marietta GA) and Doumas reference serum or plasma total bilirubin (TSB).

Design And Methods: Pooled samples with values assigned by the Doumas reference method were used to establish the relationship between a local laboratory and reference Doumas TSB. We then established the relationship between TcB and TSB in the 3 months before and after reassignment of calibrator setpoints undertaken to match the local laboratory to Doumas reference bilirubin values.

Evaluation of the BiliChek noninvasive bilirubin analyzer for prediction of serum bilirubin and risk of hyperbilirubinemia.

We identified clinical and laboratory variables affecting the relationship between transcutaneous and serum bilirubin levels and determined whether transcutaneous bilirubin values could be used to predict the risk of hyperbilirubinemia. Median bias between transcutaneous and diazo serum bilirubin was 2.0 mg/dL (34.

Evaluation of hemoglobin interference in capillary heel-stick samples collected for determination of neonatal bilirubin.

Objective: In this study, we determined the assay performance criteria necessary to produce acceptable results for >or=98% of neonate bilirubin samples collected by capillary heel-stick.

Study Design And Methods: We determined serum free hemoglobin levels in 151 heel-stick serum samples to determine the hemolysis level. We then tested the effect of hemolysis on total bilirubin levels determined by four commercially available assays.