CA15-3
ZECEN
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PRINCIPLE OF THE TEST
Sandwich method：
CA15-3 Antibody labeled by FITC and CA15-3 Antibody pair labeled by AP bind with the CA15-3 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.
Preparation for Analysis
• Patient specimens with a cloudy or turbid appearance must be centrifuged prior to testing. Following centrifugation, avoid the lipid layer (if present) when pipetting the specimen into a sample cup or secondary tube.
• Specimens must be mixed thoroughly after thawing by LOW speed vortexing or by gently inverting, and centrifuged prior to use to remove red blood cells or particulate matter to ensure consistency in the results. Multiple freeze-thaw cycles of specimens should be avoided.
• All samples (patient specimens, controls, and calibrators) should be tested within 3 hours of being placed on board the CIA System. Refer to the ZECEN service, for a more detailed discussion of onboard sample storage constraints.
Storage
• If testing will be delayed for more than 8 hours, remove serum or plasma from the serum or plasma separator, red blood cells or clot. Specimens removed from the separator gel, cells or clot may be stored up to 24 hours at 2-8°C. • Specimens can be stored up to 30 days frozen at -20°C or colder.
Shipping
• Before shipping specimens, it is recommended that specimens be removed from the serum or plasma separator, red blood cells or clot. When shipped, specimens must be packaged and labeled in compliance with applicable state, federal and international regulations covering the transport of clinical specimens and infectious substances. Specimens must be shipped frozen (dry ice). Do not exceed the storage time limitations identified in this section of the package insert.
PRINCIPLE OF THE TEST
Sandwich method：
CA15-3 Antibody labeled by FITC and CA15-3 Antibody pair labeled by AP bind with the CA15-3 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.
Preparation for Analysis
• Patient specimens with a cloudy or turbid appearance must be centrifuged prior to testing. Following centrifugation, avoid the lipid layer (if present) when pipetting the specimen into a sample cup or secondary tube.
• Specimens must be mixed thoroughly after thawing by LOW speed vortexing or by gently inverting, and centrifuged prior to use to remove red blood cells or particulate matter to ensure consistency in the results. Multiple freeze-thaw cycles of specimens should be avoided.
• All samples (patient specimens, controls, and calibrators) should be tested within 3 hours of being placed on board the CIA System. Refer to the ZECEN service, for a more detailed discussion of onboard sample storage constraints.
Storage
• If testing will be delayed for more than 8 hours, remove serum or plasma from the serum or plasma separator, red blood cells or clot. Specimens removed from the separator gel, cells or clot may be stored up to 24 hours at 2-8°C. • Specimens can be stored up to 30 days frozen at -20°C or colder.
Shipping
• Before shipping specimens, it is recommended that specimens be removed from the serum or plasma separator, red blood cells or clot. When shipped, specimens must be packaged and labeled in compliance with applicable state, federal and international regulations covering the transport of clinical specimens and infectious substances. Specimens must be shipped frozen (dry ice). Do not exceed the storage time limitations identified in this section of the package insert.
