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. |