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The Chiron Diagnostics ACS:180 BR is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

The Chiron Diagnostics ACS:180 BR assay is a fully automated, competitive, chemiluminescent assay. One reagent, designated Lite Reagent, is composed of a mouse monoclonal antibody specific for CA 27.29, labeled with acridinium ester. The antibody used in the assay, MAb B27.29, binds to a peptide epitope in the tandem repeat region of the MUC-1 gene product. The Solid Phase is composed of purified breast cancer antigen (CA 27.29) which is covalently coupled to paramagnetic particles (PMP). After onboard pretreatment, the patient serum sample is incubated with both reagents simultaneously for 7.5 minutes. The ACS: 180 system automatically performs the following steps: - dispenses sample and Pretreatment Reagent into a cuvette . - dispenses Lite Reagent and Solid Phase and incubates for 7.5 minutes u - separates, aspirates and washes the cuvettes - dispenses reagents which initiate the chemiluminescent reaction - = reports results An inverse relationship exists between the concentration of CA27.29 in a sample and the relative light units (RLU) detected by the system.

The Chiron Diagnostics ACS:180 BR is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the Chiron Diagnostics ACS 180: Automated Chemiluminescence Systems. The test is intended for use as an aid in monitoring patients previously treated for Stage III breast cancer. Serial testing for CA 27,29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression of disease in response to treatment.

The Chiron Diagnostics ACS:180 BR assay is a fully automated, competitive, chemiluminescent assay. One reagent, designated Lite Reagent, is composed of a mouse monoclonal antibody specific for CA 27.29, labeled with acridinium ester. The antibody used in the assay, MAb B27.29, binds to a peptide epitope in the tandem repeat region of the MUC-1 gene product. The Solid Phase is composed of purified breast cancer antigen (CA 27.29) which is covalently coupled to paramagnetic particles (PMP). The patient serum sample is incubated with both reagents simultaneously for 7.5 minutes. The ACS: 180 system automatically performs the following steps: dispenses sample into a cuvette, dispenses Lite Reagent and Solid Phase and incubates for 7.5 minutes, separates, aspirates and washes the cuvettes, dispenses reagents which initiate the chemiluminescent reaction, reports results. An inverse relationship exists between the concentration of CA 27.29 in a sample and the relative light units (RLU) detected by the system.