Applications and Grade Definitions for Tumor Marker Antigens
To assist in matching BioProcessing’s particular grades of tumor antigens with an application or product specification we offer the following information:
- Highly Purified Grade:
- Contains minor contaminants by PAGE analysis. Tumor marker antigens Ca15-3, Ca19-9 and Ca125 assayed and confirmed to contain <25% on a U/U basis of cross contaminating tumor markers as specified on product information sheets. This product is recommended for use as immunogen to make antibody or for labeling (i.e., enzyme or radio). It is also suitable for the manufacture of multiple analyte controls.
- Partially Purified Grade:
- Contains serum protein contaminants, and additional glycoproteins of other tumor markers in varying levels. We do not assay for contaminants in this grade of product. These partially pure products are often used to manufacture single analyte calibrators and controls.
- Low Cross Reactivity, Partially Purified Grade:
- Contains serum protein contaminants, but is assayed for other tumor marker glycoprotein contaminants. As an example, Ovarian Tumor Antigen, LCR, PP Grade (#8375-1303), is assayed for Ca15-3 and Ca19-9 and contains <25% on a u/u basis. This product is best suited for the manufacture of multiple analyte tumor marker controls.
- Concentrate Grade:
- Available as a low cost alternative to low cross reactivity partially pure grades for some cell culture products. Contains fetal bovine serum and other human serum protein and is not assayed for other glycoprotein contaminants. As an example, GI Tumor Antigen, cell culture concentrate, (#4250-2300), is not assayed for Ca15-3 and Ca125. This product is best suited for the manufacture of multiple analyte tumor marker controls when the client is willing to determine acceptable cross reactivity levels.
- Customized Grades:
- Many of our low cross reactivity or high pure tumor marker antigen products are customized to meet customer specifications. Additional cross reactants may be added or the percentages of these or any of the cross reactants may be altered. Quantitation methods, tumor marker analyte concentrations or buffers are typical customized items. Highly pure grades of tumor marker antigens can be altered to remove azide or applied to non-immunoassay uses such as ELIS blot assays.