The MUC-1 antigen is a membrane-anchored mucin-type glycoprotein present in malignant and normal epithelial cells of certain organs, e.g. breast, lung, ovary, pancreas and colon (1). The apoprotein of the MUC-1 mucin contains a transmembrane domain, a cytoplasmic domain, and an extracellular carbohydrate rich domain. The extracellular domain is characterized by polymorphism with respect to the number of a 20 amino acid tandem repeat (VNTR polymorphism). The CanAg CA15-3 EIA is based on two mouse monoclonal antibodies, Ma695 as catcher antibody recognizing a sialylated carbohydrate epitope expressed on the MUC-1 antigen and Ma552 as tracer antibody targeting the PDTRPAPG region of the protein core (2-5).The MUC-1 breast cancer mucin (CA15-3 antigen) is secreted from tumor cells and is a well-established serological marker for monitoring the clinical course of breast cancer patients (6).

SPECIFICATIONS

Results within:

3 hours, one step procedure

Detection limit:

< 1 U/mL

Measuring range:

1 - 250 U/mL

(may be extended by sample dilution)

Sample volume:

25 µL (diluted samples 1:41)

Hook effect:

No hook up to 7 500 U/mL

Stability:

18 months at 2-8°C

Standard range:

0 - 250 U/mL

Incubation temp:

20 - 25°C

Recovery:

95 - 110%

Detection:

620 nm or 405 nm

Correlation:

> 0.95 compared with

the Enzymun-Test CA15-3