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Ortho Clinical Gets FDA Approval to Market Blood-Grouping Reagents for Extended Phenotype Testing

NEW YORK (360Dx) – Ortho Clinical Diagnostics said today that it has received US Food and Drug Administration approval to market its Sera blood-grouping reagents with its ID-Micro Typing System gel card technology for extended phenotype testing.

Ortho's Sera reagents are used to determine the status of a designated antigen on human red blood cells. The firm noted that the reagents provide labs with a menu of antisera for phenotyping that's available in a gel testing format, and that covers more than 99 percent of the most commonly tested blood-group antigens.  

During pre-transfusion testing, labs routinely encounter patient samples that require extended typing for blood-group antigens that are outside of those most commonly tested. The patients, in these circumstances, have developed atypical antibodies and require additional testing to find compatible blood. In the US, pre-transfusion laboratories typically conduct manual extended antigen testing, Ortho noted.

Ortho's Sera blood-grouping reagents enable laboratories to increase standardization by allowing virtually all testing to be done on one system, and the reagents also help eliminate the potential for error associated with current tube-based testing, the firm said.  

"By using a standardized test system, Ortho Sera helps increase confidence in the lab and allows staff to focus on improving lab efficiency," Robert Yates, Ortho's COO, said in a statement. He noted that this addition to the firm's portfolio "furthers our goal to help lab technicians deliver reliable results to their patients despite pressures caused by limited resources and staff constraints."

Heidi Casaletto, head of transfusion medicine, said that Ortho works with laboratory technicians as they "strive toward balancing lab efficiency with their dynamic workloads and varying skill levels. A major focus of this effort is aiding laboratories in the transition from manual to automated testing."