Tony S. Casina, Robert Witkowski, Brad Roughsedge, Janine S. Robb, Emma R. Waite and Scott Burrell
Evaluation of an immunohematology testing system is necessary to show that the performance of the instrument demonstrates equivalence from a method-based perspective when compared to results of a predicate method or instrument. The ORTHO VISION® Analyzer is designed to fully automate extended antigen typing using the ID-MTS™ Gel Card (GEL) test along with a variety of ORTHO™ Sera Blood Grouping Reagents specificities. A multi-site study was conducted to evaluate the performance of the ORTHO VISION automated red cell antigen typing utilizing ORTHO Sera reagents with specific ID-MTS Gel Cards compared to the predicate test, the manual ID-MTS GEL test using the ORTHO™ Workstation. Testing included reproducibility, a measure of total precision and repeatability, which evaluates within-run test precision. This provides insight into consistency of result and degree of variability of reactivity of the automated method of testing.