Tumor Marker PGI Pepsinogen I for Fully Automatic Immunoassay Analyzer IVD Reagents 100T/box,24T/box
INTENDED USE
The kit has been designed for the quantitative determination of Pepsinogen I (PG I) in human serum.
The method can be used for samples over the range of 1.0-350.0 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 PGI antigen | 1×0.15mL |
Calibrator High:BSA buffer with high level of PGI antigen | 1×0.15mL |
PGI Anti A: PGI Antibody complex labeled FITC, containing buffer with BSA | 1×3.0mL |
PGI Anti B: PGI 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 | 1×3mL |
Calibrator Low:BSA buffer with low level of PGI antigen | 1×0.15mL |
Calibrator High:BSA buffer with high level of PGI antigen | 1×0.15mL |
PGI Anti A: PGI Antibody complex labeled FITC, containing buffer with BSA | 1×6.0mL |
PGI Anti B: PGI 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 PGI Antigen | 1×0.15 mL |
Control 2: BSA buffer with high level of PGI 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. |