C-P/INS/INS-Ab/GAD65/HbA1c Diabetes Calibrator Test Kit For Clinical In Vitro Diagnostic Analyzer
Brand Name:Zecen
Certification:CE, ISO13485
Model Number:diabetes
Minimum Order Quantity:1 boxes
Delivery Time:15 working days
Payment Terms:L/C, D/A, D/P, T/T, Western Union, MoneyGram
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Taizhou Jiangsu
Address:
Building G62, Phase 4 Plant, China Medical City, Taizhou City, Jiangsu Province
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C-P/INS/INS-Ab/GAD65/HbA1c diabetes calibrator test kit for Clinical In Vitro Diagnostic analyzer
In the traditional sense, the three tests for diabetes are the three antibodies for diabetes. The three antibodies are glutamate decarboxylase antibody, islet cell antibody, and insulin antibody. These three tests are generally used for the classification of diabetic patients. Most type 1 diabetes will be positive for one or two of the three antibodies, but with the advancement of science, the three-antibody test for diabetes is no longer limited to the previous three tests; Zecheng Bio currently also has C-peptide. and adiponectin
CLIA calibrator of DIABETES
| ITEM | C-P |
| INS | |
| INS-Ab | |
| GAD65 | |
| HbA1c |
| 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: Change of batch number of supporting testing reagents; Change of batch number of luminescent substrate The 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; System 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. |
C-P/INS/INS-Ab/GAD65/HbA1c Diabetes Calibrator Test Kit For Clinical In Vitro Diagnostic Analyzer
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