REF:

C5203 (Strip)

C5204 (Cassette)

INTENDED PURPOSE:

NOVAtest® Carcinoembryonic Antigen Test is an immunoassay that uses double-antibody sandwich method for qualitative detection of carcinoembryonic antigen (CEA) in human serum and plasma specimen. It’s used as an aid in the diagnosis of colorectal cancer. This device is performed manually.

INTENDED USER:

Performance of the test is limited to laboratory professional use.

SUMMARY:

Carcinoembryonic antigen (CEA) is a glycoprotein that is primarily produced by cells in the gut, liver, and pancreas during fetal development. Elevated levels of CEA can indicate the presence of certain cancers, particularly colorectal cancer.

CEA glycoprotein was detectable in 85% colon carcinomas patient population and found in some other types of cancer such as pancreatic, lung, and breast cancer. CEA is used as a tumor marker to aid in the diagnosis and management of cancer, particularly for monitoring disease progression or recurrence. However, elevated levels of CEA can also be caused by other conditions such as inflammation, infection, and smoking. The accuracy of CEA as a diagnostic tool varies depending on the type and stage of cancer.

Rapid CEA tests are available for diagnostic purposes and can provide quick results. CEA tests are often used in combination with other diagnostic tools such as imaging studies and biopsies to provide a more accurate diagnosis and to guide treatment decisions.