IFU.pdf

Vitro Scient's bilirubin reagent is for in vitro quantitative determination of total and direct bilirubin in serum or plasma using the diazo method according to Jendrassik-Graf. Bilirubin is formed during degradation of aged erythrocytes and transported to the liver, where it's conjugated with glucuronic acid. Total bilirubin is the sum of conjugated and unconjugated fractions. The reagent uses a series of reactions involving diazotized sulfanilic acid to form azobilirubin, with color intensity directly proportional to bilirubin concentration. Reference ranges for total and direct bilirubin are provided for adults, infants, and newborns. The assay procedure involves mixing reagents with serum specimens and measuring absorbance at specific wavelengths. Quality control is recommended using commercially available control material, with corrective actions outlined for failed controls.