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Reagent Storage, Stability & Handling
AutoPure Bilirubin is a ready to use two liquid reagent system.
Stable till the expiry date indicated on the label, when stored at 2- 8 C.
Preparation of Working Reagent
On Board Reagent Stability
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
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 .
Fully automated system automatically calculated the bilirubin concentration of each samples.
Results in mmol/l= Result in mg/dl x 17.1
Refer to the application sheet for details. For additional system applications, contact our local accurex representative.
For calibration , it is recommended to use C.F a.s or any other suitable calibrator material.
Re- calibration is recommended
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:
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.
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).
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.
Reproducibility was determined using quality control sera as shown below
Quality control material
low control serum
high control serum
Co- Relation Studies
A comparison of the bilirubin determination using autopure bilirubin and reference competitors bilirubin reagent gave the following co- realtion (mg/dl):
No of samples measured :15
The samples concentrations measured were between: