QuidelOrtho Nabs FDA 510(k) for Syphilis Assay

Original from: 360dx

QuidelOrtho announced Thursday that its Vitros syphilis assay has received 510(k) clearance from the US Food and Drug Administration and is now available globally.

The test qualitatively determines total antibodies to Treponema pallidum-specific antigens in human serum and plasma, which, in conjunction with other laboratory tests and clinical findings, may help in diagnosing syphilis, QuidelOrtho said in a statement. The test runs on the firm's automated Vitros 3600, 5600, and XT 7600 platforms.

The assay is not intended for blood and tissue donor screening, the company noted.

"Not only does this important assay improve laboratory efficiency by allowing labs to follow the CDC’s reverse testing algorithm for syphilis screening, it also reduces costs by providing earlier disease detection, thereby reducing the need to refer tests to outside labs," Bryan Hanson, QuidelOrtho's senior VP and president of North American commercial operations, said in a statement.

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Source: QuidelOrtho Nabs FDA 510(k) for Syphilis Assay