C-reactive Protein (CRP) Test Kit (CLIA) , Chemiluminescence Immunoassay test
A CLIA test kit for the quantitative determination of C-reactive Protein (CRP) in Human whole blood, serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
| Product Name: |
C-reactive Protein (CRP) Test Kit (CLIA) , Chemiluminescence Immunoassay Test |
| Principle: |
Double Antibody Sandwich Method |
| Pack: |
40T |
| Format: |
Strip |
| Storage Temperature: |
2-8℃ |
| Cat No.: |
CI-CRP |
| Specimen: |
WB/S/P |
| Shelf Life: |
2 Years |
| Certificate: |
CE |
| Cut-Off: |
0.5-150 μg/mL |
【INTENDED USE】
The C-reactive Protein (CRP) Test Kit (CLIA) is intended for quantitative determination of C-reactive Protein (CRP) in human whole blood, serum and plasma, and can be used as a sensitive marker of acute inflammation in clinic. In recent years, it has been used to assess cardiac events and risks.
For professional in vitro diagnostic use only.
【SUMMARY】
C-reactive protein is an acute phase protein with a positive pentamer structure and a molecular weight of 115 to 140KDa. It is a non-specific marker of inflammation and tissue damage. When inflammation or tissue damage occurs in the body, under the regulation of interleukin (IL)-6, IL-1, tumor necrosis factor, interferon and other cytokines, C-reactive protein is produced in time by hepatocytes and it rises rapidly (100-1000 times the normal level), reaching a peak in about 48 hours, and its half-life is only 19 hours. If the CRP value does not decrease continuously after treatment, there may be damage to the body.
Full-scale C-reactive protein includes conventional C-reactive protein (conventional CRP) and hypersensitive C-reactive protein (hypersensitive CRP). Routine CRP measurement can be used to evaluate infection, tissue damage and inflammatory diseases. For routine CRP determination, the reference value is usually considered to be clinically higher than 10 mg/L.
The CRP level in the blood of healthy people is less than 5 mg/L, and under various conditions, the CRP value reaches about 20 to 500 mg/L within 4 to 8 hours of acute inflammation. Conventional CRP as an assessment index of acute inflammation is more sensitive and reliable than erythrocyte sedimentation rate (ESR) and white blood cell count. The common use of hypersensitivity C-reactive protein can be used as an auxiliary means of cardiovascular disease risk identification.3,4 With thetraditional clinical diagnosis of acute coronary syndrome, it can be used as an early warning indicator for recurrence of coronary artery disease or acute coronary syndrome.
【PRINCIPLE】
This product uses the double antibody sandwich method. In the first step, the sample, the CRP antibody labeled with alkaline phosphatase and the magnetic particles coated with the CRP antibody are mixed. Afte incubation, the CRP in the sample forms an immune complex with the corresponding antibody. In the second step, magnetic separation and cleaning are performed to remove free enzyme-labeled antibodies. The third step is to add the chemiluminescent substrate solution to the immune complex.
Luminescence signal generated by the enzyme reaction is detected by Automatic Chemiluminescence Immunoassay Analyzer and the detected luminescence intensity is related to the concentration of CRP in the sample. Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of CRP in the sample.
【SPECIMEN COLLECTION AND PREPARATION】
Collect and handle the specimen strictly as below:
1. Collect the specimen according to standard procedures.
2. Human serum collected using standard sampling tubes or tubes containing separating gel.
3. Human whole blood and plasma are collected using EDTA or Heparin sodium.
4. Separate human serum and plasma from blood as soon as possible to avoid hemolysis. Grossly hemolytic, lipidic or turbid samples should not be used. Specimen with extensive particulate should be clarified by centrifugation prior to use. Do not use specimens with fibrin particles or contaminated with microbial growth.
5. Do not leave specimens at room temperature for prolonged periods. Serum and Plasma specimens may be stored at 2-8 °C for up to 3 days, below -20 °C stable for 3 months. Whole blo od collected by venipuncture should be stored at 2-8 °C if the test is to be used within 1 day of collection. Do not freeze whole blood specimens.
6. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing.
Specimens should not be frozen and thawed repeatedly.
7. If the patients had been treated by high dose of biotin (5 mg/day), blood collection must be done after at least 8 hours.
8. If specimens are to be shipped, pack them in compliance with local regulations covering the transportation of etiologic agents.
【DIRECTIONS FOR USE】
Refer to Automatic Chemiluminescence Immunoassay Analyzer Operation
Manual for the complete instructions on 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 1 week 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 betested 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.
3. 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 CRP 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 controlsto 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.
