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Beta-Human Chorionic Gonadotropin Assay Detects Early Pregnancy

By LabMedica International staff writers
Posted on 06 Oct 2008
Beta-human chorionic gonadotropin (Beta-hCG) appears in serum soon after conception, and is an ideal indicator for detection and confirmation of pregnancy. More...
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


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