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.
