Name Breast Cancer Antigen (CA 15-3)
What is CA 15-3 CA 15-3 is derived from the MUC1 gene and overexpression of MUC1 is often associated with colon, breast, ovarian, lung and pancreatic cancers.
What is it used for? CA 15-3 is used as an important marker for cancer detection particularly breast cancer.
Source Human Fluids
Purity Low cross contamination (< 10 %) for CA 125, CA 19-9, CA 72-4, CEA, AFP and Ferritin reported as activity of cross contaminants/activity of CA 15-3 in U/ml.
Testing method ECLIA
Stability 3 years (Real time)
Storage 2-8°C
Molecular weight ~400 KDa
Viral testing Negative for HBs-Ag, Anti-HCV and Anti-HIV I & II using CLIA (US- FDA approved) and for absence of viral DNA/RNA for HBV, HIV and HCV using PCR

YBL Native CA 15-3 salient features

  • Purity: Low cross contamination for CA 125, CA 19-9, CA -72-4, CEA, AFP and Ferritin was observed and cross contaminants are reported as activity of cross contaminants/activity of CA 15-3 in U/ml. The passing criteria is < 25%, however, YBL tries to restrict the levels to < 10 % for cross contamination.
  • Stability data: CA 15-3 low cross (part pure) is stable for 3 years at 2-8°C based on the real time stability study.
  • Testing Method: ECLIA
  • Testing Platform: Roche-cobas
  • Viral testing: The viral marker test for HBs-Ag, Anti-HCV and Anti-HIV (I and II) was done using CLIA (US-FDA Approved). The antigen was also tested for the absence of viral DNA/RNA for HBV, HIV (I) and HCV using PCR technology.

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