Tumor Marker CA15-3 Carbohydrate Antigen 153 IVD CLIA Reagents
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Tumor Marker CA15-3 Carbohydrate Antigen 153 IVD CLIA Reagents

The kit has been designed for the quantitative determination of Cancer Antigen 15-3 (CA15-3) in
human serum.
The method can be used for samples over the range of 1.0~600.0 U/mL .
The test has to be performed Taizhou Zecen Biotech Co., Ltd. model CIA 600, CIA 600Plus, CIA
1200, CIA 1200M, CIA 1800, CIA 2800 and POClia 8, POClia minus, POClia plus, POClia auto
automatic chemiluminescence analyzer.
Shenzhen IncreCare Biotech Co., Ltd. model Shine i1900、Shine i2900 automatic chemiluminescence analyzer.
  • CA15-3


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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. 


• 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. 


• 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.

Zecen Biotech CO., LTD. founded in 2011, is a leading Chinese diagnostics manufacturer specializing in in-vitro diagnostics devices and reagents.
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