Introduction
Reagent Storage Stability Handling
AutoPure Lipase is a ready to use two liquid reagent
Shelf life
Stable till the expiry date indicated on the label when stored at 28C
On Board Reagent Stability
Components & Concentration of Working Solution
Components Concentration
Components Concentration
Specimen Collection Preservation
Collect sample using standard sampling tube Serum heparinized plasma with Lithium or Sodium can be used Lipase activity in serumplasma is stable for 5 days at 28C and 24 hours at 2025C Centrifuge samples containing precipitate before performing the assay
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 Cfas or any other suitable calibrator material.
Calibration frequency
Re calibration is recommended
Quality Control
Each batch of AutoPure Lipase is assayed with atleast six quality control sera Precinorm Precipath Biorad 1 Biorad 11 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 commercial 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 Values
SerumPlasma
Adults 13 60 IU1 02171002 pkatl at 37 C
Note
Expected range varies from population to population It is therefore recommended that each laboratory should establish its own range For diagnostic purposes the Lipase results should always be assessed in conjunction with the patients medical history clinical examinations and other findings
Performance Characteristics
Linearity
With AutoPure Lipase the assay is linear upto 300 IU1 501 pkatl Determine samples with higher concentrations via the rerun function On instruments without rerun function manually dilute samples with higher concentrations using 09 NaCI or distilleddeionized water eg 1 4 Multiply the result by the appropriate dilution factor eg 5
Interference
There is no significant interference in samples containing upto 60 mgdl of bilirubin and 500 mgdl of haemoglobin
Precision
Reproducibility was determined using quality control sera as shown below
Within run | Between run | |||||
Quality Control Material | Means 1U/1 | SD 1U/1 | CV | Means 1U/1 | SD 1U/1 | CV |
Low Control Serum | 13.3 | 1.52 | 1.1 | 140 | 1.85 | 1.4 |
High Control Serum | 456 | 2.53 | 0.6 | 475 | 2.32 | 0.9 |
Co Relation Studies
Acomparison of the Lipase determination using AutoPure Lipase and Infinite Lipase reagent gave the following corelation IU1
Linear Regression
No of samples measured 72
The sample concentrations measured were between 5 and 661 IU1
References
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