Extended antigen typing, mainly executed using manual techniques in tube-based tests, has many failure modes. Testing a single sample with multiple antisera or a single antiserum with many samples along with variable reagent methodology are major hazard contributors amongst the many potentials for error. Automation of immunohematology testing offers considerable risk reduction by minimizing the many error opportunities through process control.
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® Max Analyzer is designed to fully automate extended antigen typing using the ID-MTSTM Gel Card (GEL) test along with a variety of ORTHOTM Sera Blood Grouping Reagent specificities. Testing reproducibility, a measure of total precision and repeatability, evaluates within-run test precision. This provides insight into consistency of result and degree of variability of reactivity of the automated method of testing.