Active Member
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Address: Building G62, Phase 4 Plant, China Medical City, Taizhou City, Jiangsu Province
Contact name:Liu
Taizhou Zecen Biotech Co.,Ltd. |
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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. |
