Bilirubin Total & Direct 4+1 Clinical Chemistry Reagent, Elitech: 2 x 125 ML, Generic [700 Tests]

Description

INTENDED USE

ELITech Clinical Systems BILIRUBIN TOTAL 4+1 is intended for the quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma on adults and children over 10 days.

CLINICAL SIGNIFICANCE

Approximately 80-85 % of the bilirubin produced is derived from the hememoiety of the released from aging erythrocytes in the reticudothelial 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 hemolytic anaemia) and in case of disorders of bilirubin metabolism and transport defects

PRINCIPLE 

Sulphanilic acid reacts with sodium nitrite to form diazotized sulphanilic acid. In the presence of accelerator (cetrimide), conjugated and unconjugated bilirubin react with diazotized sulphanilic acid to form azobilirubin (Bilirubin Total 4+1). In the absence of accelerator, only conjugated bilirubin reacts (Bilirubin Direct 4+1). The increase of absorbance at 546 nm is proportional to bilirubin concentration.

REAGENTS COMPOSITION

BILIRUBIN TOTAL 4+1

Reagent 1: R1

Sulphanilic acid 29 mmol/L

Cetrimide 29 mmol/L

BILIRUBIN DIRECT 4+1

Reagent 1: R1

Sulphanilic acid 29 mmol/L

BILIRUBIN TOTAL & DIRECT 4+1

Reagent 2: R2

Sodium nitrite 11 mmol/L

MATERIALS REQUIRED BUT NOT PROVIDED

• CALI-0550  ELICAL 2 4 x 3 mL
• CONT-0060 ELITROL I 10 x 5 mL
• CONT-0160 ELITROL II 10 x 5 mL
• Normal saline solution (NaCl 9 g/L)
• General Laboratory equipment.
• Do not use materials that are not required as indi- cated above.

WARNINGS AND PRECAUTIONS

These reagents are for professional in vitro diagnostic use only.
The reagents R1 contain sulphanilic acid . They may produce an allergic reaction.
For more information, refer to the Safety Data Sheet (SDS).
Take normal precautions and adhere to good laboratory practice.
Use clean or single use laboratory equipment only to avoid contamination.
Do not interchange reagent vials from different kits.

STABILITY OF REAGENTS
Store at 2-8 °C and protect from light. Do not freeze.

Do not use after expiration dates indicated on the vial labels.

On board stability:

The on-board stability is specific for each analyzer. (Refer to § PERFORMANCE DATA).

PREPARATION

The reagents are ready to use.

REAGENT DETERIORATION
The reagent R1 of Bilirubin Total 4+1 can be slightly cloudy. It contains a detergent that can lead to the formation of foam in washing units of some equipments. These two characteristics are without consequences on the product performances.
The reagent R1 of Bilirubin Direct 4+1 and the reagent R2 of Bilirubin Total & Direct 4+1 should be clear. Cloudiness would indicate deterioration.

Do not use the product if there is visible evidence of biological, chemical or physical deterioration

REFERENCE VALUES 

Serum, plasma :

Adults and children over 10 days : 0.2 – 1.2 mg/dL ( 3.4 – 21 μmol/L)

Note : The quoted range should serve as a guide only. It is recommended that each laboratory verifies this range or establishes a reference interval for the intended population

PROCEDURE

For ELITech Clinical Systems Selectra Analyzers,

applications are available on request.

Total Bilirubin Wavelength : 546-700 nm Temperature: 37 °C

Read against reagent blank.