FDA Clears Olympus Beta-hCG Assay, A High-Medical-Value Test for the Early Detection of Pregnancy
Center Valley, PA, October 1, 2008 – Olympus, a leader in the field of in vitro diagnostics, has received 510(k) clearance from the US Food and Drug Administration 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.
About this Hormone
During the early weeks of pregnancy, Beta-hCG is important in maintaining function of the corpus luteum. During the first trimester of pregnancy (8–10 weeks), the production of Beta-hCG doubles every 48 hours to a peak at about 10 weeks after the last menstrual cycle and gradually decreases for the remainder of the pregnancy. Within a few weeks after delivery Beta-hCG is no longer detectable. Ectopic pregnancies and pregnancies terminating in spontaneous abortion have lower circulating Beta-hCG levels, while higher levels are often seen in multiple pregnancies.
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.
Olympus is a precision technology leader, creating innovative opto-digital solutions in healthcare, life science and consumer electronics products. Olympus works collaboratively with its customers and its affiliates worldwide to leverage R&D investment in precision technology and manufacturing processes across diverse business lines. These include:
· Gastrointestinal endoscopes, accessories, and minimally invasive surgical products;
· Advanced clinical and research microscopes;
· Lab automation systems, chemistry-immuno and blood bank analyzers and reagents;
· Digital cameras and voice recorders.