FDA Clears ORTHO™ Sera ID-MTS for Use on the ORTHO VISION® Analyzer
RARITAN, N.J., Oct. 18, 2019 /PRNewswire/ -- Ortho Clinical Diagnostics a global leader of in vitro diagnostics, today announced that ORTHO™ Sera, a suite of extended antigen phenotyping, has been cleared by the U.S. Food and Drug Administration for use on the ORTHO VISION® Analyzer.
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.1 ORTHO Sera's extended phenotype testing covers more than 99 percent of the most commonly tested blood group antigens, providing support for patients with unexpected antibodies.
"It is critically important for lab professionals to deliver the right results for complex and chronically transfused patients," said Bob Stowers, head of Ortho's transfusion medicine product portfolio. "That's why we are excited to be the first to offer automated extended phenotype testing, saving time for the lab professional and giving skilled staff the ability to focus on other critical tasks in the lab, as well as to increase the lab's ability to standardize testing."
Allowing virtually all testing to be done on one platform, ORTHO Sera expands the testing menu on the ORTHO VISION Analyzer, driving greater value and efficiency for customers and delivering results in a maximum of 20 minutes. With end-to-end full automation on the ORTHO VISION Analyzer, 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.
ORTHO Sera's antisera additive approach allows extended phenotyping to be personalized according to patient needs, which reduces waste and enhances efficiency. Decreased hands-on manipulation of tests helps to eliminate time-consuming, non-value-added activities and potential for error. The 13 ORTHO Sera reagents available in the U.S. on the ORTHO VISION Analyzer include Anti-Fya, Anti-Fyb, Anti-Jka, Anti-Jkb, Anti-S, Anti-s, Anti-K, Anti-D (IAT), Anti-D (DVI), Anti-P1, Anti-Lea, Anti-Leb and Anti-N.
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1 Hamilton JR_Common and Frequently Encountered Antibodies_Transfusion and Apheresis Science 2009_ 40_189_194
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SOURCE Ortho Clinical Diagnostics