Bilirubin Total 164

Bilirubin Total 164

Product Details:

  • Physical Form Liquid
  • Shape other
  • Other Names Biochemistry Reagent
  • Smell Other
  • Taste Other
  • Usage Bilirubin reacts with diazotized sulphanillic acid in acidic medium to produce azobillirubin . DMSO catalyzes the formation of azobillirubin from free bilirubin. Bilirubin+ Sulphanilic acid + Sodiu Nitrite- Azobilirubin
  • Shelf Life 18 Months
  • Supply Ability : 10000 Kit Per Day
3355 INR/Kit
X

Price And Quantity

  • 3355 INR/Kit
  • 1 Kit

Product Specifications

  • 1000
  • other
  • Reagents
  • Liquid
  • Other
  • ACC9074
  • 18 Months
  • Biochemistry Reagent
  • Bilirubin reacts with diazotized sulphanillic acid in acidic medium to produce azobillirubin . DMSO catalyzes the formation of azobillirubin from free bilirubin. Bilirubin+ Sulphanilic acid + Sodiu Nitrite- Azobilirubin
  • Biochemistry Reagent
  • Other
  • Biochemistry Reagent
  • Other

Trade Information

  • EXW ABPL
  • Paypal, Cash Against Delivery (CAD), Cash in Advance (CID), Cheque, Letter of Credit (L/C), Letter of Credit at Sight (Sight L/C)
  • 10000 Kit Per Day
  • 2 Days
  • packaging : Empity
  • Asia, Australia, Central America, North America, South America, Eastern Europe, Western Europe, Middle East, Africa
  • All India
  • certification : iso

Product Description

Introduction

  •  AutoPure Bilirubin is a reagent kit for direct quantitative determination of total and direct bilirubin in human serum and plasma on automated clinical chemistry analyzers.
  •   AutoPure Bilirubin is ready to use ,two liquid reagent system.
  • With   AutoPure Bilirubin , the assay is linear upto 20 mg/dl( 342mmol/l).

Principle

  •  Bilirubin reacts with diazotized sulphanillic acid in acidic medium to produce azobillirubin . DMSO catalyzes the formation of azobillirubin from free bilirubin.
  •  Bilirubin+ Sulphanilic acid + Sodiu Nitrite- Azobilirubin 
  • Direct   Bilirubin, being water soluble directly reacts in acidic medium to produce Azobilirubin .
  •  Bilirubin+ Sulphanilic acid + Sodiu Nitrite- Azobilirubin 
  • The intensity of the violet colour formed is directly proportional to the concentration of bilirubin in the specimen and is measured photometrically.
  • Abbreviations: DMSO= Dimethyl Sulphoxide

Reagent Storage, Stability & Handling

 AutoPure Bilirubin is a ready to use two liquid reagent system.

Shelf life  

Stable till the expiry date indicated on the label, when stored at 2- 8 C.

Preparation of Working Reagent  

  • For Total Working Reagent take 50 parts of total bilirubin R1 and add 1 part of total bilirubin R2 
  • e.g Take 10 ml total bilirubin R1 and add 0.20 ml of total bilirubin R2.
  • For Direct Working Reagent take 50 Parts of direct bilirubin R1 and add 1 part of direct bilirubin R2
  • e.g  Take 10ml of direct bilirubin R1 and add 0.20ml of  direct bilirubin R2.

On Board Reagent Stability

  •  Total: 10 days at 2- 8 C.
  • Direct: 10 days at 2-8 C.
  • Protect the Reagent From light and contamination. 
  • Do not freeze the reagent. 

Note: Over a period of time, the total and Direct bilirubun working reagents may develop a yellow tinge. This is expected and does not impair performance of the assay.

Components & Concentration of Working Solution                             

  • Stabilizers, excipients & surface active agents     

Specimen collection & Preservation

Collect sample using standard sampling tube. Although serum is preferred, heparinized plasma or EDTA plasma can be used . Haemolysis interferes. Store samples protected from light as bilirubin is light sensitiv. Bilirubin in serum/plasma is stable for 1 day at 2-8 C and for 30 days at -20 C. Centrifuge samples containing precipitate before performing assay .

Calculations 

Fully automated system automatically calculated the bilirubin concentration of each samples.

Results in mmol/l= Result in mg/dl x 17.1

Application Sheet 

Refer to the application sheet for details. For additional system applications, contact our local accurex representative.

Calibration

 For calibration , it is recommended to use C.F a.s or any other suitable calibrator material.

Calibration frequency  

Re- calibration is recommended 

  • Whenever the reagent lot is changed .
  • As per the requirement of quality control procedured.

Quality Control

Each batch of autopure bilirubin is assayed with atleast six quality control sera- Precinorm, precipath, bioradl, bioradll, accutrol normal and Accutrol abnormal prior to release.

To ensure adequate quality control, it is recommended that the laboratory should use a normal and abnormal commerical reference control serum. It should be realized that the use of quality control material checks both the reagent and instrument functions together.

If the control values fall outside the specified limits, each of the below criteria should be cross checked and corrected:

  • Proper instruments function- wavelength setting, light source and temperature control.
  • Cleanliness of probes and cuvettes.
  • Bacterial contamination of wash water used by the instrument.
  • Expiry date of the reagent kit. 

Expected Values 

Serum/Plasma 

Total bilirubin-

  • Adults : 0.1-1.1 mg/dl( 1.71-18.8 mmol/l)
  •  Infants 1.2 - 12 mg/dl( 20.52 -205.2 mmol/l) 

Note: 

Expected range varies from population to population. it is therefore recommended that each laboratory should establish its own normal range. For diagnostic purposes, the bilirubin results should always be assessed in diagnostic purposes, the bilirubin results should always be assessed in conjuction with the patients medical history clinical examinations and other findings.

Performance Characteristics 

Linearity 

With Autopure Bilirubin , the assay is linear up to 20 mg/dl (342 mmol/l).Determine samples with higher concentration via the rerun function . On instrument without rerun function, manually dilute samples with higher concentration using 0.9% NaCl or distilled/deionized water (e.g. 1+3 ). Multiply the result by the appropriate dilution factor (e.g. 4).

Interference

 Haemolysis interferes in samples from adults. Occasionally , slighty higher values for direct bilirubin than for total bilirubin may be yielded by samples in which the totl and direct bilirubin concentrations are similar. In such samples, the bilirubin concentration determined by both methods should be stated.

Precision

Reproducibility was determined using quality control sera as shown below

 

Within run

Between run

Quality control material

Means mg/dl

sd mg/dl

CV

Means mg/dl

sd mg/dl

CV

low control serum

0.73

0.01

0.7

0.77

0.02

2.5

high control serum

2.02

0.01

0.5

2.3

0.05

2.1

 Co- Relation Studies

A comparison of the bilirubin determination using autopure bilirubin and reference competitors bilirubin reagent gave the following co- realtion (mg/dl):

Linear Regression

                                        Total

  • y=                             0.974x +0.101 
  • r=                             0.9995
  • Sy.x=                      0.22

No of samples measured :15

The samples concentrations measured were between:

  • Total :0.70 mg/dl and 20.0 mg/dl
  • Direct : 0.40 mg/dl and 8.70 mg/dl

References

  •  Tietz N.W. ed. clinical guide to laboratory tests, 3rd ed. philadelphia pa :W.B. Saunders, 1995:88.
  • Malloy HT, Evelyn KA. The determination of bilirubin with the photoelectric colorimeter.JBiol. chem 1937;119 : 481-490.
  • Wahlefeld AW, Herz G , Bernt E. Modification of the Malloy- Evelyn method for a samples, reliable determination of total bilirubin in serum scand.j clin. lab . invest 1972;29 supplement 126:Abstract 11.12.
  • Pearlman, P.C & Lee, R.T Clin. Chem 20 :447 (1974)
  • Henry , rj (ed.) clinical chemistry : principal and teachniques (2nd ed) Harper and pow p 1042 (1979)
  • Jendrassik L & Grof P . bIOCHEM 2.297 ,81 (1938)
  • Practical clinincal biochem.vol 1, 5 th ed. H Varley,p 1012 (1980) 
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