Carcinoembryonic Antigen Determined by Immunoassay in 28 Minutes

A carcinoembryonic antigen (CEA) immunoassay detects a group of markers indicating the presence of carcinomas such as those present in the colon.

The assay is a two-step chemiluminescent, paramagnetic particle, enzyme immunoassay with a measuring range of approximately 0.08 - 500 ng/mL. It measures quantitative concentrations of CEA in 50 µL of either serum or lithium-heparin plasma samples after 28 minutes of processing time.

Olympus, (Center Valley, PA, USA) has received U.S. Food and Drug Administration (FDA; Rockville, MD, USA) clearance for the Carcinoembryonic Antigen (CEA) immunoassay using the Olympus AU3000i immunoassay system. Samples containing CEA concentrations exceeding 500 ng/mL are autodiluted onboard (1:1000) for a clinical reportable range of approximately 500,000 ng/mL. Each CEA kit is sufficient to process 200 tests, and contains CEA reagents, a single ready-to-use calibrator, and a single ready-to-use control. Reagents are stable onboard the AU3000i system for 28 days.

Olympus Diagnostic Systems provides solutions that meet the high productivity demands of hospitals, integrated healthcare delivery networks, reference labs, blood banks, physicians' office labs, veterinary labs, and pharmaceutic labs. Olympus offers a broad standardized line of random access chemistry analyzers, along with immunoassay analyzers, lab automation systems, blood bank analyzers, and reagents. Olympus solutions save laboratories time, maximize productivity, and deliver fast, reliable results.

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U.S. Food and Drug Administration