New High-Sensitivity CRP Assay

The assay has been cleared by the U.S. Food and Drug Administration (FDA).

The hsCRP assay is used to quantitatively measure C-reactive protein in human serum and plasma. It is the first hsCRP assay on a random access system cleared for use in assessing the risk of developing coronary heart disease. The assay and this new random access system, called Vitros 5,1 FS chemistry system, are the products of Ortho-Clinical Diagnostics (Raritan, NJ, USA; www.orthoclinical.com). The Vitros system has also been cleared by the FDA.

The Vitros 5,1 FS is the first Vitros system that will support the new Vitros MicroTip technology, which provides an extended menu of proteins, therapeutic drugs of abuse, and other critical assays. MicroTip technology is unique in that assays are processed using disposable tips and cuvettes. This eliminates the maintenance and cost associated with water, wash reagents, plumbing, drains, fixed probes, and mixing assemblies. The Vitros 5,1 also features Ortho-Clinical's MicroSlide, Intellicheck, and MicroSensor technologies.

"Expanding our menu of assays for the Vitross family of systems is part of our continuing investment in the clinical laboratory, and in particular the development of markers with high clinical value,” said Stephanie Wells, vice president, marketing, Worldwide Clinical Laboratory Franchise, Ortho-Clinical Diagnostics.




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Ortho-Clinical Diagnostics