IVD Reagents

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The Pchem Total Bilirubin Reagent Kit has been designed for use in the quantitative determination in vitro of the concentration of the Total Bilirubin in human serum or plasma. The results of the test must always be interpreted in conjunction with the clinical picture.

This kit is intended for In vitro diagnostic use only, must not be sold to the general public and the test has to be carried out by a health-care professional person.

The kit contains reagents sufficient for 822 tests.

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).

METHOD

Mally – Evelyn modified. End point.

Total and direct bilirubin levels are used for the diagnosis and control of hepatic (hepatitis, cirrhosis), haemolytic and biliary disorders. In particular, high levels of total bilirubin can be indicative of excessive haemolysis or hepatic disorders of the hemoglobin catabolism.

STANDARDIZATION

Jendrassik-Grof mod.

Sulfanilic acid reacts with sodium nitrite to form diazotized sulfanilic acid. In the presence of accelerator (centrimide), conjugated and unconjugated bilirubin react with diazotized sulfanilic acid to form azobiliburin (Bilirubin Total 4+1). In the absence of accelerator, only conjugated bilirubin reacts (Bilirubin direct 4+1). The increase of absorbance at 550 nm is proportional to bilirubin concentration.

Sulfanilic acid + NaNO2 → Diazotized sulfanilic acid

Bilirubine + Diazotized sulfanilic acid → Azobilirubin

Pchem Total Bilirubin Reagent Kit

Code ADA-R0100000101

Reagent 1 (R1) - 4 x 41 mL/vial

Reagent 2 (R2) - 4 x 10.5 mL/vial