Interleukin-6 (IL-6) Test Kit (CLIA) , Automatic Chemiluminescence Immunoassay Analyzer
Interleukin-6 (IL-6) is an inflammatory mediator released by cells that plays an important role in the immune system. It has multiple physiological functions such as reducing nutrient deficiency and relieving inflammation. It also promotes coagulation, inhibits heart disease, suppresses protein synthesis, and provides anti-oxidative effects.
Recent research has shown that IL-6 is a key factor in the development of cancer and can activate cell proliferation, promote angiogenesis and accelerate the metastasis and invasion of cancer cells. It can also suppress immune responses such as those of cancer patients. Therefore, controlling the production of IL-6 may help in controlling the development of cancer.
A CLIA test kit for the quantitative determination of Interleukin-6 (IL-6) concentration in human whole blood, serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
【INTENDED USE】
The Interleukin-6 (IL-6) Test Kit (CLIA) is intended for quantitative determination of Interleukin-6(IL-6) in human whole blood, serum and plasma, as an aid in the diagnosis of sepsis in clinical practice. For professional in vitro diagnostic use only.
【SUMMARY】
Interleukin-6 (IL-6) is a multifunctional cytokine produced by various cells, which plays an important role in immune response, acute response and hematopoietic modulation.1 IL-6 changes significantly in a variety of diseases and its malregulated expression can cause many diseases, clinical manifestations are mainly increased IL-6 levels at the onset ofdiseas e. IL-6 is rapidly produced during acute inflammatory responses to internal and external injuries, surgery, stress reactions, infections, brain death, tumor formation and other conditions. IL-6 concentration in patients undergoing surgery can predict the risk of surgical complications.
Continuous testing of serum or plasma LEVELS of IL-6 in intensive care patients can effectively assess the severity of systemic inflammatory response syndrome (SIRS), sepsis and prognosis of septic shock. Increased serum levels of IL-6 predate PCT and CRP and can be used as an early warning indicator of sepsis. Il-6 also plays an important role in chronic inflammatory responses such as rheumatoid arthritis.
【PRINCIPLE】
This product adopts double antibody sandwich method. The first step is to mix the sample with an alkaline phosphatase-labeled IL-6 antibody and magnetic particles coated with IL-6 antibody. After incubation, the IL-6 in the sample forms an immune complex with corresponding antibodies. In the second step, magnetic separation and cleaning were carried out to remove free enzyme-labeled antibodies.
The third step is to add chemiluminescent substrate solution to the immune complex.
Luminescence signal generated by the enzyme reaction was detected by Automatic Chemiluminescence Immunoassay Analyzer and the detected luminescence intensity is related to the concentration of IL-6 in the sample. Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of IL-6 in the sample.
【REAGENTS】
The reagent strip includes IL-6 antibody coated with magnetic particles, alkaline phosphatase labeled with IL-6 antibody, wash buffer and substrate solution.
【DIRECTIONS FOR USE】
Refer to Automatic Chemiluminescence Immunoassay Analyzer User Manual for the complete instructions for use of the analyzer.
1. Preparation
1) Take the test kit from the refrigerated environment and use it after equilibrating to room temperature.
2) Dissolution of the Calibrator and Control:
Add 500 μL of purified water to each Calibrator/Control for reconstitution.
Dissolved calibrators /controls are stable for 5 days when stored at 2-8 °C.
3) Input reagent information
Before using a new batch of reagents, the reagent information should be entered.
Run the analyzer software, enter the adding reagent interface and scan the reagent information QR code in the information card to input
the test information.
2. Calibration
1) When using a new batch of reagents, calibration must be priority performed after the reagent information is entered.
2) The system requires double parallel tests for calibrator 1 and calibrator 2 and will assign 2 test slots to calibrator 1 and calibrator 2 respectively by default and the four tests should be done in one time.
Follow calibration procedures according to the user manual of the analyzer.
Load the reagent strips, then add 100-150 μL of corresponding dissolved calibrator 1 and 2 to the corresponding sample well of the reagent strips, finally tap the start button to perform the calibration tests.
3) Calibration frequency:
Once a calibration is accepted and stored, all subsequent samples may be tested without further calibration unless:
A reagent kit with a new lot number is used.
Reagents of the same batch number have been used for more than 4 weeks.
As required: For example, controls testing are out of range. REF CI-IL6 English .
Quality Control
1) Input Quality control information
Input the QC information into the system by scanning the QR code of the quality control in the information card provided with the kit.
2) Follow control procedures according to the user manual of the analyzer.
3) Load the reagent strips and add 100-150 μL of corresponding dissolved control materials, then tap the start button to perform the control tests.
The recommended control requirement for the IL-6 test is a single test of all control levels tested once every 24 hours in daily use. If the quality control procedures in your laboratory require more frequent use of controls to verify test results, follow your laboratory-specific procedures.
Make sure the control values are within the defined ranges. Each laboratory should establish corrective measures to be taken if
control values fall outside the defined limits.
4. Sample test
Sample test can be performed on condition that the test results of calibration and quality control meet the requirements. (Calibration results indicate successful and Control results fall within the specified ranges in the information card.)
Tap [Analy] and select [IL-6] item.
Follow sample test procedures according to the user manual of the analyzer.
Load the reagent strips and add 100-150 μL of sample to the sample well, and tap Start button. After the detection is finished, the concentration will be calculated by the software and displayed on the screen.
5. Dilution
Specimens with a IL-6 value exceeding 5000 pg/mL are flagged with the code “>5000” and may be diluted manually and test again. 50mM Tris buffer is recommended as sample diluents.
Note: After manual dilution, the dilution factor should be considered when calculate the final results.
For detailed information, please refer to the User Manual of Automatic Chemiluminescence Immunoassay Analyzer.
