| product composition | 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. |
