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June 12, 2017

Bio-Rad receives FDA clearance for new assay to diagnosis syphilis

Clinical diagnostic products developer Bio-Rad Laboratories has obtained the US Food and Drug Administration (FDA) clearance for its BioPlex 2200 Syphilis Total and RPR assay designed to diagnose syphilis infection.

Clinical diagnostic products developer Bio-Rad Laboratories has obtained the US Food and Drug Administration (FDA) clearance for its BioPlex 2200 Syphilis Total and RPR assay designed to diagnose syphilis infection. 

To enable effective monitoring of treatment, the BioPlex 2200 Syphilis features fully automated Treponemal/non-Treponemal dual assay that simultaneously detects Treponema pallidum (T. Pallidum) and reagin antibodies, as well as the level of antibody measured as RPR titer.

When compared to existing manual RPR card tests, the automation of examination is claimed to allow labour savings, objective result reporting, and improved workflow to laboratories.

Bio-Rad Clinical Diagnostics Group president John Hertia said: “The addition of the BioPlex 2200 Syphilis Total and RPR assay broadens our expanding BioPlex 2200 System infectious disease menu while offering laboratories a simplified approach to syphilis testing. It is adaptable to any testing algorithm used by a laboratory.”

"When compared to existing manual RPR card tests, the automation of examination is claimed to allow labour savings, objective result reporting, and improved workflow to laboratories."

The system facilitates quick process or multiplex of several individual tests that are usually processed separately.

The multiplex feature of the system aids in conserving patient sample volume and simplifies the workflow.

Founded in 1952, Bio-Rad develops, manufactures and markets a variety of products and solutions for life science research and clinical diagnostics.

The firm operates across universities, research institutions, hospitals, public health and commercial laboratories, biotechnology, pharmaceutical, and food safety industries.


Image: Darkfield photomicrograph of Treponema pallidum bacteria. Photo: courtesy of CW Hubbard/CDC.

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