FDA Clears VITROS XT MicroSlides

April 9, 2019
Patrick Campbell

MicroSlides allows labs to run two tests simultaneously, optimizing workflow and improving performance.

A new, multi-test technology, which allows labs to run two tests simultaneously, has received clearance from the US Food and Drug Administration.

Ortho Clinical Diagnostic’s VITROS XT MicroSlides allows physicians to test triglycerides and cholesterol, urea and creatinine, or glucose and calcium at the same time using one MicroSlide.

"Labs today are challenged to run increasing volumes of tests in shorter timeframes, with less physical space available for larger analyzers," said Michael Iskra, head of Ortho's North America operations. "Because they enable the simultaneous running of two tests that are typically ordered together, our VITROS XT MicroSlides address these numerous challenges with one elegant solution."

VITROS XT MicroSlides, which are for use on the VITROS XT 7600 Integrated System, are designed to improve performance and productivity in clinical labs by enabling a higher test throughput without additional or larger analyzers. MicroSlide allows measurements of different fluids through a spectral reaction that occurs when the fluids come into contact with dry chemical layers.

In addition to potentially simplifying workflow, the MicroSlides require less patient blood sample for each of the paired tests. Ortho Clinical Diagnostic had previously announced the product had received its CE mark in early March 2019, signifying conformance to applicable European Union regulatory requirements.

Ortho's VITROS XT MicroSlides, which include VITROS® XT UREA-CREA, TRIG-CHOL and GLU-Ca Slides, have been cleared by the U.S. Food and Drug Administration. These products are available on the VITROS XT 7600 Integrated System in numerous countries, including the U.S., Canada, Chile, France, Germany, Hong Kong, Iceland, Italy, Spain, Switzerland, the U.K., Australia, Liechtenstein, Norway and New Zealand.