ORTHO Sera ID-MTS antigen phenotyping cleared on ORTHO VISION Platform in United States and Canada

Ortho Clinical Diagnostics, a global leader of in vitro diagnostics dedicated to improving and saving lives through innovative laboratory solutions, announced its ORTHO Sera, ID-MTS, a suite of extended antigen in a gel testing format used for blood phenotyping for patients in need of transfusion, is cleared to run on ORTHO VISION^® and ORTHO VISION^® Max in the United States and Canada. The clearances allow testing for more than 99% of the most commonly tested blood group antigens to be performed on one platform, driving greater value and efficiency.

The suite was cleared by the U.S. Food and Drug Administration for use on the ORTHO VISION^® Analyzer in October 2019, and for use on the ORTHO VISION^® Max in January 2020. The suite received Health Canada approval in January 2020.

“Ortho Clinical Diagnostics is proud to offer our laboratory partners solutions that help them quickly test donor blood for the most-needed phenotypes and confidently provide it to patients in need of transfusion,” said Bob Stowers, head of Ortho's transfusion medicine product portfolio. “With the ability to analyze the most commonly tested antigens on a single ORTHO VISION system and results in under 25 minutes, lab teams are better equipped to help clinicians focus on what matters most—treating their patients.”

During pre-transfusion testing, lab professionals routinely encounter complex patient samples that require extended antigen typing. These patients have developed atypical antibodies to blood group antigens and require additional testing to find compatible blood.

Its antisera additive approach means customers always have the appropriate reagents available and allows extended phenotyping to be personalized according to patient needs—reducing waste and enhancing efficiency.

With end-to-end full automation on the ORTHO VISION and ORTHO VISION Max analyzers, ORTHO Sera minimizes the potential for human error—improving safety—and provides consistent, reliable results while freeing up lab professionals to focus on value-added tasks.

The 13 ORTHO Sera reagents available in the U.S. and Canada on the ORTHO VISION Analyzer and ORTHO VISION Max include Anti-D (DVI), Anti-D (IAT), Anti-Fya, Anti-Fyb, Anti-Jka, Anti-Jkb, Anti-K, Anti-Lea, Anti-Leb, Anti-N, Anti-P1, Anti-S, Anti-s.

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