Properties
Highly purified native breast cancer (CA 15-3) antigen derived from
human fluids
Specification
Identification (ELISA Calbiotech): Positive
CA 15-3 content (Roche Elecsys®): >10 kU/mL
Purity Ratio (Roche Elecsys®): Activity/ml/OD280 nm
Co product 19-9: <25%
Co product 125: <25%
Co product AFP: <25%
Co product 72-4: <25%
Co Product Ferritin: <25%
Co product CEA: <25%
Bioburden: <10 CFU/mL
Viral Marker Test (ELISA) for HBsAg, Anti-HCV and Anti-HIV I + II
(US-FDA approved BioRad & Ortho Clinical Diagnostics): Negative
Absence of viral DNA/RNA (HBV, HIV I and HCV; PCR): Negative
Stability: At +2 to +8°C within specification range for 10 months.
Quality
Extensively tested for absence of HBsAg, Anti-HCV and Anti-HIV I + II
(ELISA), and for viral DNA/RNA (PCR: HBV, HIV I and HCV) by applying
FDA-approved methods.
Background information
Liquid (aseptically filtered) in 50 mM PBS (pH 7.2 -7.6) and 0.09% w/v
sodium azide