Olympus Announces FDA Clearance and U.S. Release of AFP Assay For AU3000i® Immunoassay System
CENTER VALLEY, Pa., April 10, 2009 – 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.
For additional information about the Olympus AU3000i immunoassay system and related assays, contact Susan M. Watanabe at 1-484-896-5686, or via email at Susan.Watanabe@olympus.com; visit www.olympusamerica.com/AU3000i.
About this test
The Olympus AFP assay is a paramagnetic particle chemiluminescent immunoassay for the in vitro quantitative measurement of AFP in human serum or lithium-heparin plasma. It is traceable to the 1st IRP WHO Reference Standard 72/225 for human AFP.
About Olympus Diagnostic Systems
Olympus Diagnostic Systems provides innovative solutions that meet the high productivity demands of hospitals, integrated healthcare delivery networks, reference labs, blood banks, physician offices and pharmaceutical labs. Olympus offers the broadest standardized line of random access chemistry-immuno analyzers, along with lab automation systems, blood bank analyzers and reagents. Olympus solutions save laboratories time, maximize productivity, and deliver fast, reliable results.
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