Product for use in the quantitative determination in vitro of the concentration of the
Direct Bilirubin in human serum or plasma. The results of the test must always be
interpreted in conjunction with the clinical context. For professional use only.
CLINICAL SIGNIFICANCE
Approximately 80-85 % of the bilirubin produced is derived from the heme moiety of the
haemoglobin released from aging erythrocytes in the reticuloendothelial cells. Bilirubin,
bound to albumin, is transported into the liver where it is rapidly conjugated with
glucuronide to increase its solubility. Then it is excreted into biliary canaliculi, and
hydrolyzed in the gastrointestinal tract.
Unconjugated bilirubin serum concentration increases in case of overproduction of
bilirubin (acute or chronic haemolytic aniemias) and in case of disorders of bilirubin
metabolism and transport defects (impaired uptake by liver cells: Gilbert’s syndrome;
defects in the conjucation reaction: Crigler-Najjar syndrome). Reduced excretion
(hepatocellular damage: hepatitis, cirrhosis, Dubin-Johnson and Rotor syndrome) and
obstruction to the flow of bile (most often produced by gallstones or by tumors) induce
an important elevation of conjugated bilirubin and in a minor extent an increase of
unconjugated bilirubin (conjugated hyperbilirubinemia).