Tumor Marker PGII Pepsinogen II for Fully Automatic Immunoassay Analyzer IVD Reagents 100T/box,24T/box
INTENDED USE
The kit has been designed for the quantitative determination of Pepsinogen II (PG II) in human serum.
The method can be used for samples over the range of 0.5-150.0 ng/mL.
The test has to be performed on the CIA fully auto analyzer (Including CIA 600, CIA 1200, CIA 1800, CIA2800).
KIT COMPONENTS
Material Supplies
Reagent Integral for 50 determinations | |
Magnetic beads: TRIS buffer, magnetic beads complex binding with goat anti-FITC, buffer with BSA | 1×1.5mL |
Calibrator Low:BSA buffer with low level of PGII antigen | 1×0.15mL |
Calibrator High:BSA buffer with high level of PGII antigen | 1×0.15mL |
PGII Anti A: PGII Antibody complex labeled FITC, containing buffer with BSA | 1×3.0mL |
PGII Anti B: PGII Antibody complex labeled by AP, containing buffer with BSA | 1×3.0mL |
All reagents are provided ready-to-use. |
Reagent Integral for 100 determinations | |
Magnetic beads: TRIS buffer, magnetic beads complex binding with goat anti-FITC, buffer with BSA | 1×3.0mL |
Calibrator Low:BSA buffer with low level of PGII antigen | 1×0.15mL |
Calibrator High:BSA buffer with high level of PGII antigen | 1×0.15mL |
PGII Anti A: PGII Antibody complex labeled FITC, containing buffer with BSA | 1×6.0mL |
PGII Anti B: PGII Antibody complex labeled by AP, containing buffer with BSA | 1×6.0mL |
All reagents are provided ready-to-use. |
Reagent Vials in kit box | |
Control 1: BSA buffer with low level of PGII Antigen | 1×0.15 mL |
Control 2: BSA buffer with high level of PGII Antigen | 1×0.15 mL |
target value refer to Quality Control sheet |
Accessories Required But Not Provided
Substrate | REF: SR2001 |
System Washing solution | REF: WR2001 |
Probe Washing Solution | REF: WR2002 |
product composition | Two points: LH |
Six points: ABCDEF | |
Testing method | 1. Treat the calibrator as the sample to be tested, and place it in the sample loading area of the instrument after mixing. Note that when mixing Avoid air bubbles. |
2. During the detection, the system detects the luminescence value (RLU value) of each calibration point, and calculates the luminescence value according to the nominal concentration and luminescence value. | |
The calibration curve is automatically fitted by the instrument. In order to ensure the reliability of the calibration curve, the determination of the calibrator should be | |
Make a double. | |
3. The generated calibration curve can be used for 28 days, but it should be re-calibrated after the following conditions: | |
① Change of batch number of supporting testing reagents; | |
Change of batch number of luminescent substrate | |
②The measured value of the quality control product is not within the scope of quality control or the test results are inconsistent with the clinical situation; | |
③System for major repairs or maintenance. | |
Interpretation of test results | 1. For reasons such as methodology or antibody specificity, the same sample was tested using reagents from different manufacturers. |
Testing with different reagents may give different test results, therefore, the results obtained by testing with different reagents should not be directly | |
They are compared with each other in order to avoid false medical interpretations. | |
2. The quality control product can be used as a reference for the reliability of the current experimental results, and its measured value should be within the | |
within the range allowed by the quality control sheet. Test results should be based on reference value ranges and other clinical factors and results | |
Comprehensive judgment, when the test result is close to the upper limit or lower limit of the reference value range, it can be considered | |
samples for confirmation testing. | |
Storage and expiration date | Stored at 2-8°C, the product is valid for 12 months. Reagents should be used within 1 month after opening, and stored at 2-8°C away from direct sunlight. |