Beta-Human Chorionic Gonadotropin Assay Detects Early Pregnancy

It can be detected in serum as early as six days after conception.

A two-step paramagnetic particle (Dynabeads) chemiluminescent immunoassay enables the diagnostic quantitative determination of total Beta-hCG levels in 50 µl of human serum. The assay is calibrated against the fourth World Health Organization (WHO; Geneva, Switzerland) Standard 75/589 for human Beta-hCG, and has an approximate measuring range of 0.05-1,000 international units/liter (IU/l).

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.

Olympus Diagnostic Systems (Center Valley, PA, USA), a company dealing in in-vitro diagnostics, has received 510(k) clearance from the U.S. Food and Drug Administration to market the Beta-hCG assay for the early detection of pregnancy. The assay is designed for use with the Olympus fully automated AU3000i immunoassay system. For samples with Beta-hCG concentration exceeding 1000 IU/L, the AU3000i automatically performs a 1:200 dilution.

Olympus Diagnostic Systems provides solutions for hospitals, integrated healthcare delivery networks, reference labs, blood banks, physician offices, and pharmaceutic labs. Olympus offers a broad line of random access chemistry-immunoanalyzers, along with lab automation systems, blood bank analyzers, and reagents.

Related Links:
World Health Organization
Olympus Diagnostic Systems