ISE reagent is an in vitro assay intended for direct quantitative deter-mination of K, Na, Cl, Ca in human serum. The test designed to be performed on the BC1200, BC2200 chemistry analyzer electrolyte module and IBE6000, IBE8000 Electrolyte module manufactured by SNIBE Co., Ltd
Package
Calibration A: 1000 ml
Calibration B: 500 ml
Quality control product: 10 ml
Assay Principle
Electrolyte module use ion-selective electrode to test the activity of Naã€Kã€Clã€Ca in the sample. The ion-selective electrode contacts with the sample to be tested, then the relation between output voltage and the activity of ion is consistent with Nernst formula, so certain ion activity can be measured. Calibration A and calibration B are mainly used for the two-point calibration of electrolyte module and the one-point calibration during the testing process. The two-point calibra-tion of electrolyte module is to confirm the slope of the ion electrodes, while the one-point calibration during the test is to make up the mea-suring error caused by electrode voltage drift.
Use the quality control product to test the result of Electrolyte module to confirm if it is in good condition. If the result is within the reference range claimed in the instruction, then it is in good condition. If it is out of the range, then the operator should mend the device.
Notice:
1. Do not interchange integral component from different reagents or lots.
2. Reagents are provided ready-to-use.
3. Appearance of Reagent solutions should be clear. If turbid, it shows the reagents are deteriorated.
Reagent Stability and Storage
1. Reagents must be stored at 2–8°C and avoid direct sunlight. Sealed reagents are stable for 12 months within expiry date; opened reagents are stable for not less than 28 days.
2. Reagents must be shipped at 2–8°C, no damage or leaking.
3. DO NOT FREEZE.
Materials Required But Not Provided
+ Purified water
+ Cuvette, reaction disk
+ Acid cleaning solution, alkaline cleaning solution, antibacterial phosphorus-free fluid
Specimen Collection and Stability
Specimen: serum(avoid hemolysis)
Test Procedure
1. Reagent preparation
Reagents are all provided ready-to-use. 2. Test procedure
Use Calibration A and calibration B for the calibration of electrolyte module. After the function of the electrolyte module is confirmed according to the result of the Quality control test, test the sample, the concentration of ion can be calculated by electromotive force.
3. Calculations and Results
Cx = Ca x 10( Ex - E A )/ S
Cx:ion concentration of the sample CA:ion concentration of calibration A Ex:tested electrode potential EA:electrode potential of calibration A S:slope of electrode
Expected Values
The 0.95 Reference interval for Kã€Naã€Clã€Ca from a population of 120 healthy people aging from 20-60 years old is:
Serum Na:136 mmol/L ~ 145 mmol/L Serum K:3.5 mmol/L ~ 5.2 mmol/L Serum Cl:96 mmol/L ~ 108 mmol/L Serum Ca:2.0 mmol/L ~ 2.6 mmol/L
Results may differ between laboratories due to variations in population and test method. Each laboratory should establish its own reference range.
Clinical Significance
Electrolyte in the human body can maintain osmotic balance, the water distribution, pH stability, adjust the heart and muscle function and electron transfer, also as accessory factor for enzyme. The imbalance of electrolyte in the human is related to lots of diseases. To test the concentration of Naã€Kã€Clã€Ca can be used to assess the patient’s condition.
Limitations
Hemolysis samples may cause the rise of K, so it should be avoided. For diagnostic purposes, Kã€Naã€Clã€Ca concentrations should always be assessed in conjunction with the patient’s medical history, clinical examination and other diagnostic procedures.
Performance Characteristics
Repeatability
Test the Quality control products for analytical elements, the variable coefficient CV≤1.5%.
Repeatability