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Ortho Clinical Diagnostics Multitest Technology Gets FDA Clearance

NEW YORK (360Dx) – Ortho Clinical Diagnostics said today that the US Food and Drug Administration has cleared its Vitros XT MicroSlides multitest technology, which allows labs to run two tests simultaneously on one MicroSlide.

By pairing tests that physicians often order together so that the tests can be run simultaneously instead of separately, MicroSlide technology can improve performance and productivity in the clinical lab and enable a higher test throughput without requiring additional or larger analyzers, Ortho said. In a statement Michael Iskra, head of Ortho’s North America operations, said that laboratories are challenged to run increasing volumes of tests in shorter timeframes with less physical space available for larger analyzers.

The Vitros MicroSlide technology provides an integrated test environment on a thin piece of film. Spreading, masking, scavenger, and reagent layers are discretely combined on one postage-stamp-sized slide, Ortho said. 

Ortho’s MicroSlides also use digital chemistry technology while running on the Vitros XT 7600 Integrated System, a clinical chemistry and immunoassay system for mid- and high-volume that the FDA cleared last November.

Available Vitros XT MicroSlides include Vitros XT UREA-CREA, TRIG-CHOL, and GLU-Ca Slides. Urea and creatinine; triglycerides and cholesterol; and glucose and calcium are among the available paired tests.

In March, the products received CE marking for marketing in European Union countries and other countries that recognize the designation.

The products are available in the US, Canada, Chile, France, Germany, Hong Kong, Iceland, Italy, Spain, Switzerland, the United Kingdom, Australia, Liechtenstein, Norway, and New Zealand.