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FDA Clears Ortho Clinical Diagnostics Extended Blood Phenotyping Reagents

NEW YORK – Ortho Clinical Diagnostics said today that the US Food and Drug Administration has cleared its Ortho Sera suite of reagents that enable extended antigen phenotyping.

The product was cleared for use with the Ortho Vision analyzer.

Ortho said that the reagents cover more than 99 percent of the most commonly tested blood group antigens, providing support for patients with unexpected antibodies. The reagents' antisera additive approach allows extended phenotyping to be personalized according to patient needs, reducing waste, and enhancing efficiency, the firm said.

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

"It is critically important for lab professionals to deliver the right results for complex and chronically transfused patients," Bob Stowers, head of Ortho's transfusion medicine product portfolio, said in a statement. He added that automated extended phenotype testing saves time for lab professionals, gives skilled lab staff the ability to focus on other critical tasks, and increases the lab's ability to standardize testing.