Olympus recieves FDA clearance for Beta-HCG assay
An
Olympus America product story
Edited by the Laboratorytalk editorial team
Oct 7, 2008
Olympus America has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the beta-human chorionic gonadotropin (Beta-HCG) assay.
The Beta-HCG assay is a test used for the early detection of pregnancy and is designed for use with the AU3000I immunoassay system.
The Olympus Beta-HCG assay is a two-step paramagnetic particle (Dynabeads) chemiluminescent immunoassay for the diagnostic quantitative determination of total Beta-HCG levels in 50 microlitres of human serum.
The assay is calibrated against the fourth WHO Standard 75/589 for human Beta-HCG, and has an approximate measuring range of 0.05-1,000 IU/L.
For samples with Beta-HCG concentration exceeding 1,000 IU/L (1,000 mIU/mL), the AU3000i can automatically perform a 1:200 dilution.
The test kit contains reagents, as well as a single ready-to-use calibrator and a ready-to-use quality control.
Calibration frequency is every 28 days and on-board stability of reagents is also 28 days.
The appearance of Beta-HCG in serum soon after conception makes it the ideal indicator for the detection and confirmation of pregnancy.
Beta-HCG can be detected in serum as early as six days after conception.
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