FDA Licenses ORTHO™ Sera designed for Extended Phenotype Testing for Use with Ortho ID-MTS™ Gel Card Technology
Monday, August 28, 2017
Source: Ortho Clinical Diagnostics
RARITAN, N.J. – August 28, 2017 – Ortho Clinical Diagnostics (Ortho), a global leader of in vitro diagnostics, today announced that ORTHO™ Sera blood grouping reagents designed for extended phenotype testing has been licensed for commercialization in the United States by the U.S. Food and Drug Administration (FDA) for use with ID-Micro Typing System™ Gel Card technology. Ortho Clinical Diagnostics is the only provider in the U.S. that offers a comprehensive menu of antisera for extended antigen phenotyping in a gel testing format.
During pre-transfusion testing, labs routinely encounter patient samples that require extended antigen typing for blood group system antigens beyond those most commonly tested (A, B, D). These patients have developed atypical antibodies (i.e. K, Lea, Leb), which require additional testing to find compatible blood. In the United States, pre-transfusion laboratories typically conduct extended antigen testing manually via tube testing.
ORTHO™ Sera’s 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 percent of the most commonly tested blood group antigens1.
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 the 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 helps to 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,” said 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. This allows extended phenotyping to be personalized according to patient needs, which reduces waste and enhances efficiency. ORTHO™ Sera also reduces 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,” said 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 ORTHOTM Sera reagents available for use with ID-MTS gel card technology include:
- Anti-D (IAT)
- Anti-D (DVI)
Further automation of rare phenotyping using Ortho’s instrumentation is expected in the future.