Lumipulse^® G CA125-II

Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analytes listed in the lot specific assigned values sheet.

Immunoreaction cartridges for in vitro diagnostics (IVD) use with the LUMIPULSE G System for the quantitative measurement of HE4 in human serum or plasma (sodium haparin, lithium heparin, or dipotassium EDTA) on the LUMIPULSE G System.

The CanAg CA125 EIA kit is intended for the quantitative determination of the cancer associated antigen CA125 in serum.

The HE4 EIA is an enzyme immunometric assay for the quantitative determination of HE4 in human serum. The assay is to be used as an aid in monitoring response to therapy for patients with invasive epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. It is further intended to be used in conjunction with either ARCHITECT CA 125 II or CanAg CA125 EIA or Lumipulse G CA125II as an aid in estimating the risk of epithelial ovarian cancer in premenopausal and postmenopausal women presenting with pelvic mass. The results must be interpreted in conjunction with other methods in accordance with standard clinical management guidelines.

The CA125 monoclonal antibodies recognize epitopes in the protein core of the CA125 antigen.