Direct Bilirubin L-Type Assay

Description

Direct Bilirubin L-Type Assay is an in vitro diagnostic (IVD) test for the quantitative determination of Direct Bilirubin (D-BIL) in serum and plasma.

In human blood, bilirubin exists in two forms. Unconjugated (indirect) bilirubin is transported to the liver bound by albumin where it is conjugated with glucuronic acid and excreted as direct bilirubin. Elevated serum bilirubin is indicative of impairment of the liver. The increase in total bilirubin, associated with obstructive jaundice, is primarily due to the direct bilirubin.

Direct Bilirubin L-Type Assay is a liquid type reagent that is based on a chemical oxidation method utilizing vanadate as an oxidizing agent (vanadate oxidation method).

Reagent 1, Reagent 2 and a calibrator are required for this assay.

All reagents and calibrators are CE-certified according to Directive 98/79/EC on in vitro diagnostic medical devices.

Key Features

  • Stable liquid ready-to-use reagent
  • Open bottle stability: 1 month at 2-10° C
  • Highly precise and specific
  • No significant interference by hemolysis, ascorbic acid and lipaemic turbidity

References

Diagnosis of hyperbilirubinaemia may rely on direct bilirubin (D-BIL) measurement. Specimen suitability for D-BIL depends on the degree of haemolysis and method specifications. A recent study compares the D-BIL measurement in haemolytic sera from adults and neonates using the Diazo and the vanadate-oxidation method.

Storage

Store Reagent 1 and calibrator at 2-10° C.
Store Reagent 2 at 2-35° C.

Ready-to-use Test Components
OEM test components for this assay are available on request.