Taizhou Zecen Biotech Co.,Ltd.
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CLIA Calibrator Kit 6-points for Thyroid TSH/TT3/TT4/FT3/FT4/TGAB/TG/TPOAB/TRAB in CIA1200M/CIA1800
It is used in conjunction with Jiangsu Zecen Biotech Co., Ltd. or Taizhou Zecen Biotech Co., Ltd. Total Thyroid Detection Kit (Magnetic Particle Chemiluminescence Method) and applicable models, for the calibration of Thyroid detection.
Applicable Instruments
CIA600, CIA 1200M, CIA 1800 automatic chemiluminescence instrument produced by Taizhou Zecen Biotech Co., Ltd.
Testing Method
1. Treat the calibrator as the sample to be tested. After mixing, place it in the sample loading area of the instrument. Be careful not to create air bubbles when mixing.
2. During detection, the system detects the luminescence value (RLU value) of each calibration point. The calibration curve is automatically fitted by the instrument according to the nominal concentration and luminescence value. To ensure the reliability of the calibration curve, the determination of the calibrator should be done in duplicate.
3. The generated calibration curve can be used for 28 days, but should be re-calibrated when the following conditions occur;
| 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. |
