The Ortho Sera suite of blood grouping reagents from Ortho Clinical Diagnostics, Raritan, NJ, has received an FDA license for US commercialization for use with the company’s ID-Micro Typing System (ID-MTS) gel card technology.
During pretransfusion testing, labs routinely encounter patient samples that require extended antigen typing for blood group system antigens beyond those most commonly tested (A, B, D). Such samples are from patients who have developed atypical antibodies that require additional testing to find compatible blood. In the United States, pretransfusion laboratories typically conduct extended antigen testing manually via tube testing.
Designed for extended phenotype testing, the Ortho Sera suite of reagents is used to determine the status of a designated antigen on human red blood cells. Ortho Sera provides labs with the only comprehensive menu of antisera for phenotyping available in a gel testing format, covering more than 99% of the most commonly tested blood group antigens.
Ortho Sera enables laboratories to increase standardization by allowing virtually all testing to be done on one system, helping to eliminate the many non-value added activities and potential for error associated with current tube-based testing. Many blood banks use a combination of manual and automated testing in an effort to accommodate dynamic workloads, variable skill levels, and budget constraints. Ortho Sera was developed to help maintain consistency in the lab and deliver precise, accurate results.
“By using a standardized test system, Ortho Sera helps increase confidence in the lab and allow staff to focus on improving lab efficiency,” says Robert Yates, chief operating officer at Ortho Clinical Diagnostics. “This addition to Ortho Clinical Diagnostics’ comprehensive, integrated product portfolio furthers our goal to help lab technicians deliver reliable results to their patients despite pressures caused by limited resources and staff constraints.”
Ortho Sera enables customized, flexible profile testing through an antisera additive approach, permitting extended phenotyping to be personalized according to patient needs. The system also reduces the potential for error associated with current tube-based phenotyping reagents by offering clean, stable, and well-defined end points that eliminate objective interpretation.
“Ortho Clinical Diagnostics works with laboratory technicians as they strive toward balancing lab efficiency with their dynamic workloads and varying skill levels,” says Heidi Casaletto, head of transfusion medicine at Ortho Clinical Diagnostics. “A major focus of this effort is aiding laboratories in the transition from manual to automated testing. Our portfolio of solutions brings consistency and reliability in an ever-changing lab environment.”
The 13 Ortho Sera reagents available for use with ID-MTS gel card technology 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, and Anti-S.
For more information, visit Ortho Clinical Diagnostics.