Description
Product Specifications
COA
IFU
Instrument
Description
Cancer Antigen (CA15-3), a high molecular weight mucin, and similar MUC-1 based glycoprotein markers (e.g. BR27-29) may be used to monitor response to treatment, rising serum concentrations providing early indication of progression in some patients. It is normally found in breast tissue. Antigens are Y-shaped proteins that identify a cell, acting as its unique “signature.” CA15-3 has great clinical significance in the diagnosis of breast cancer. In the early stage of breast cancer, the sensitivity is low, 30%, but in the late stage, the sensitivity is up to 80%, which has important value in the efficacy, prognosis, recurrence and metastasis diagnosis of breast cancer. Other malignant tumors also have a certain positive rate, and in the liver, gastrointestinal tract, lung, breast, ovarian and other non-malignant tumor disease, the positive rate of less than 10%.
Product Specifications
Intended Use
Cancer Antigen 15-3 Assay Kit is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of Cancer Antigen 15-3 (CA15-3) in human serum and plasma. The assay kit is intended for in vitro diagnostic use.
Principle
The Cancer Antigen 15-3 assay is a quantitative sandwich immunoassay to determine the presence of CA15-3 in human serum
and plasma using CMIA technology with flexible assay protocols.
- Sample, assay diluent, paramagnetic anti-CA15-3 coated microparticles and a conjugate containing acridinium-labeled anti-CA15-3 are mixed, CA15-3 present in the sample binds to anti-CA15-3 coated microparticles and acridinium-labeled anti-CA15-3, forming an antigen antibody complex.
- After further incubation and washing, Pre-Trigger and Trigger Solutions are added to the reaction mixture.
- The resulting chemiluminescent reaction is measured as relative light units (RLUs). There is a relationship between the amount of CA15-3 in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the previously established calibration curve.
Storage
The kit should be stored upright, not upside down or horizontally. Store at 2–8°C with a validity period of 12 months.
COA
IFU
Instrument