Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay

This category covers diagnostic test kits designed to measure levels of the cancer antigen 15-3 (CA15-3) protein in patient samples. Clinically, these tests are primarily used to help monitor disease progression and response to treatment in individuals diagnosed with breast cancer. They are not used for screening or initial diagnosis in the general population.

These devices are supplied as complete reagent kits and associated materials intended for use in clinical laboratory settings. They operate using a chemiluminescent immunoassay method, which generates a light signal to detect and quantify the target antigen. Laboratories typically integrate these kits into automated analyzers for high-throughput processing of clinical specimens.