Olympus announces they have received 510(k) clearance from the US Food and Drug Administration (FDA) to market the Beta-Human Chorionic Gonadotropin (Beta-hCG) assay, a test used for the early detection of pregnancy. The assay is designed for use with the fully automated AU3000i® Immunoassay System.
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.
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 microliters of human serum. The assay is calibrated against the 4th WHO Standard 75/589 for human Beta-hCG, and has an approximate measuring range of 0.05 – 1000 IU/L. For samples with Beta-hCG concentration exceeding 1000 IU/L (1000 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.
“With this latest FDA clearance, Olympus continues to build its menu of important assays and offers laboratories the ability to process these frequently ordered tests on the high-capacity AU3000i Immunoassay System,” said Lorraine Damico, Director of Immunoassay Marketing for Olympus America Inc.
