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

QuidelOrtho

VITROS syphilis assay now available on the VITROS 3600 Immunodiagnostic System, and the VITROS 5600 and VITROS XT 7600 Integrated Systems in the US

4 Sept 2024

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VITROS® XT 7600 Integrated System

VITROS® XT 7600 Integrated System

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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Clinical MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.SyphilisAssay DevelopmentThe process of proving an assay to be sensitive with respect to the target is known as assay development. The assay should be able to characterize novel compounds and measure the potency of these compounds against a validated biological target.FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices. Infectious DiseasesInfectious diseases are caused by pathogens such as bacteria, viruses, and fungi. Effective detection, prevention, and treatment are crucial to control outbreaks and improve public health. Diagnostic tools, vaccines, and antimicrobial treatments are essential components of managing these diseases. Research into emerging pathogens and resistance patterns continues to evolve. Browse our peer-reviewed product directory to find the best diagnostic tools, prevention solutions, and treatment options; compare products, read customer reviews, and get pricing directly from manufacturers.

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