CEA
ZECEN
| Quantity: | |
|---|---|
PRINCIPLE OF THE TEST Sandwich method：
CEA Antibody labeled by FITC and CEA Antibody pair labeled by AP bind with the CEA antigen in the sample, control or calibrator and form sandwich complex. Then add the magnetic beads binding with Anti-FITC, through the specific binding between the FITC and Anti-FITC, the complex will be bound by the magnetic beads. Then the entire complex will be captured by the external applied magnetic field and separate from the unbound substance. After washing, add the substrate. The substrate will be catalytically cracked under the action of the enzyme, and form an unstable intermediate in excited state. When the intermediate in excited state returns to the ground state, it will issue photons and make a light-emitting reaction. Then the CLIA analyzer will measure the luminous intensity and count the results through software by comparing the luminous intensity with the cutoff value to determine whether the corresponding antibody exists.
TRACEABILITY AND CALIBRATION
1) Traceability
To perform an accurate calibration, we have provided the test calibrators standardized against the National Standard for Carcinoembryonic Antigen Immunoassay by National Institutes of Food and Drug Control.
2) 2 or 6 Point Recalibration Via the measurement of calibrators, the predefined master curve is adjusted (recalibrated) to a new, instrument-specific measurement level with each calibration.
3) Frequency of Recalibration
⚫ After each exchange of lots (Reagent Integral or substrate Reagents).
⚫ Every week and/or each time a new Integral is used (recommendation).
⚫ After each servicing of the CIA Fully Auto analyzer.
⚫ If controls are beyond the expected range.
PRINCIPLE OF THE TEST Sandwich method：
CEA Antibody labeled by FITC and CEA Antibody pair labeled by AP bind with the CEA antigen in the sample, control or calibrator and form sandwich complex. Then add the magnetic beads binding with Anti-FITC, through the specific binding between the FITC and Anti-FITC, the complex will be bound by the magnetic beads. Then the entire complex will be captured by the external applied magnetic field and separate from the unbound substance. After washing, add the substrate. The substrate will be catalytically cracked under the action of the enzyme, and form an unstable intermediate in excited state. When the intermediate in excited state returns to the ground state, it will issue photons and make a light-emitting reaction. Then the CLIA analyzer will measure the luminous intensity and count the results through software by comparing the luminous intensity with the cutoff value to determine whether the corresponding antibody exists.
TRACEABILITY AND CALIBRATION
1) Traceability
To perform an accurate calibration, we have provided the test calibrators standardized against the National Standard for Carcinoembryonic Antigen Immunoassay by National Institutes of Food and Drug Control.
2) 2 or 6 Point Recalibration Via the measurement of calibrators, the predefined master curve is adjusted (recalibrated) to a new, instrument-specific measurement level with each calibration.
3) Frequency of Recalibration
⚫ After each exchange of lots (Reagent Integral or substrate Reagents).
⚫ Every week and/or each time a new Integral is used (recommendation).
⚫ After each servicing of the CIA Fully Auto analyzer.
⚫ If controls are beyond the expected range.
