Introduction
Principle
Reagent Storage, Stability & Handling
AutoPure Calcium Arsenazo III is ready to use, single liquid reagent system.
Shelf life
Stable till the expiry date indicated on the label, when stored at 15-25C.
On - Board Reagent Stability
Components & Concentration of Working Solution
Components Concentration
Specimen Collection & Preservation
Calculations
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
Quality Control
Each batch of AutoPure Calcium Arsenazo III 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
Serum/Plasma
Adults : 8.6 -10.2 mg/dl (2.15 -2.55 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 calcium results should always be assessed in conjunction with the patients medical history, clinical examinations and other findings.
Performance Characteristics
Linearity
With AutoPure Calcium Arsenazo III, the assay is linear upto 15 mg/dl (3.75 mmo1/1). Determine samples with higher concentrations via the rerun function. On instruments without rerun function, manually dilute samples with higher concentrations using 0.9% NaCI or distilled/deionized water (e.g. 1 + 2). Multiply the result by the appropriate dilution factor (e.g. 3).
Interference
There is no significant interference in samples containing upto 40 mg/dl of bilirubin and 1000 mg/dl of haemoglobin
Precision
Reproducibility was determined using quality control sera as shown below:
| Within run | Betweenrun | ||||
Quality control marerial | Means mg/dl | SD mg/dl | CV | Means mg/dl | SD mg/dl | CV |
low control serum | 9.12 | 0.09 | 13.4 | 9 | 0.14 | 1.5 |
high control serum | 13 | 0.1 | 0.8 |
| 0.14 | 1 |
Co Relation Studies
A comparison of the calcium determination using AutoPure Calcium Arsenazo III and AutoZyme Calcium Arsenazo III reagent gave the following co relation (mg/dl):
Linear Regression
No of samples measured : 72
The sample concentrations measured were between 9 mg/dl and 12 mg/dl.
References
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