Olympus announced FDA Clearance for AFP Assay For AU3000i Immunoassay System


Olympus, a leader in the field of in vitro diagnostics, has received FDA clearance for an Alpha-fetoprotein (AFP) test for the Olympus AU3000i immunoassay system. The appearance of elevated AFP concentrations in adult serum is useful in the detection of certain malignant cancers.

The Olympus AFP assay is a two-step paramagnetic particle enzyme immunoassay with a measuring range of approximately 0.1 – 390 ng/mL. It measures quantitative concentrations of AFP in 20 microliters of either serum or lithium-heparin plasma samples after 28 minutes of processing time. Samples containing an AFP concentration exceeding 390 ng/mL are auto-diluted onboard (1:1000) to give a clinically reportable range of approximately 390,000 ng/mL. Each AFP kit is sufficient to process 200 tests, and contains AFP reagents, a single ready-to-use calibrator, and a single ready-to-use control. Reagents are stable onboard the AU3000i system for 28 days.