| Product Name: |
Procalcitonin (PCT) Test Kit (CLIA), Chemiluminescence Immunoassay, Quantitative Determination Of Procalcitonin |
| Principle: |
Double Antibody Sandwich Method |
| Pack: |
40T |
| Format: |
Strip |
| Storage Temperature: |
2-8℃ |
| Cat No.: |
CI-PCT |
| Specimen: |
WB/S/P |
| Shelf Life: |
2 Years |
| Certificate: |
CE |
| Cut-Off: |
0.05-100 Ng/mL |
Procalcitonin (PCT) Test Kit (CLIA), Chemiluminescence Immunoassay, quantitative determination of Procalcitonin
A CLIA test kit for the quantitative determination of Procalcitonin (PCT) in human whole blood, serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
【INTENDED USE】
The Procalcitonin (PCT) Test Kit (CLIA) is intended for quantitative determination of procalcitonin (PCT) in human whole blood, serum and plasma, as an aid in the diagnosis of bacterial infectious diseases in clinical practice.
For professional in vitro diagnostic use only.
【SUMMARY】
Procalcitonin (PCT) is a hormonally inactive calcitonin propeptide with a molecular weight of 12.6 kD. Since PCT is proteolytically broken down in individuals with normal metabolism, PCT is usually present at undetectable levels (<0.1 ng/mL) in healthy subjects. In severe infections and sepsis caused by bacteria, fungi and parasites, PCT serum titer may increase to
more than 500 ng/mL. Currently, mononuclear blood cells are considered to be the synthesis site of procalcitonin under systemic inflammatory conditions.
Clinical evaluations in various fields of medicine show that PCT is an excellent parameter.
1) For early diagnosis of systemic bacterial and fungal infections and sepsis.
2) Assess the severity of systemic infections, sepsis and multiple organ failure and predict the outcome.
3) Used to monitor the development of infection in high-risk patients, such as after surgery or organ transplantation, immunosuppressed or multiple trauma patients.
4) For the differential diagnosis of systemic infections and acute inflammatory diseases.
5) Used for differential diagnosis of bacterial infection and viral infection.
【PRINCIPLE】
This product uses double antibody sandwich method. In the first step, the sample, the PCT antibody labeled with alkaline phosphatase and the magnetic particles coated with the PCT antibody are mixed. After incubation, the PCT 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 the Automatic Chemiluminescence Immunoassay Analyzer and the detected luminescence intensity is related to the concentration of PCT in the sample. Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of PCT in the sample.
【REAGENTS】
The reagent strip includes PCT antibody coated with magnetic particles, Alkaline phosphatase labeled with PCT 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 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 be
REF CI-PCT Englishtested 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 PCT 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 [PCT] 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 thescreen.
5. Dilution
Specimens with a PCT value exceeding 100 ng/mL are flagged with the code “>100.00” 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.
