QuidelOrtho receives FDA 510(k) clearance for its VITROS syphilis assay

QuidelOrtho Corporation has received US Food and Drug Administration (FDA) 510(k) clearance for its VITROS^® syphilis assay.

Using the automated VITROS^® systems, this assay is intended for the qualitative determination of total (IgG and IgM) antibodies to Treponema pallidum (TP)-specific antigens in human serum and plasma using the automated VITROS^® 3600, 5600 and XT 7600 systems.

The presence of antibodies to TP-specific antigens, in conjunction with non-treponemal laboratory tests and clinical findings may aid in the diagnosis of syphilis infection. The VITROS syphilis assay is not intended for blood and tissue donor screening. With the addition of the US, the VITROS syphilis assay is now available globally where QuidelOrtho products are available.

Bryan Hanson,Senior Vice President, North American Commercial Operations at QuidelOrtho, stated, "As an in-demand assay for a common sexually transmitted infection (‘STI’), we are pleased to offer the VITROS syphilis assay, bolstering QuidelOrtho’s infectious disease test portfolio in the US. 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."

QuidelOrtho’s infectious disease test portfolio spans from point-of-care settings to high-throughput laboratories and is critical in addressing the growing syphilis epidemic in the US.

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