A multicenter study on the performance of a fully automated, walk-away high-throughput analyzer for pretransfusion testing in the US population

BACKGROUND Moving to automation is a major focus of transfusion centers. Erytra (Grifols) is a walk‐away analyzer with high‐performance and ‐throughput capacity for pretransfusion testing. Efficiency and performance of Erytra with its cards and reagents were evaluated in comparison to Food and Drug Administration (FDA)‐approved reference methods. STUDY DESIGN AND METHODS A total of 5279 blood samples (46% patients; 54% donors) were obtained from US blood establishment facilities. Samples were analyzed with Erytra and results were compared with the routine FDA‐licensed automated platforms used by the clinical study sites. A total of 25,217 tests were performed (15,322 ABO/D/reverse typing; 4916 Rh phenotypes, 669 K typing, 838 antibody screens, 759 antibody identifications, 250 cross‐matches, 244 ABO compatibilities by immediate‐spin cross‐match, and 219 direct antiglobulin tests [DATs]). RESULTS Global agreement between Erytra and the comparison platforms was 99.66%, with 99.82% positive percent agreement (95% lower confidence bound [LCB], 99.75%) and 99.50% negative percent agreement (95% LCB, 99.37%). There were 85 discrepancies (0.34%), including cross‐matches (n = 13), antibody screens (n = 10), antibody identifications (n = 21), and DATs (n = 5), whereas an excellent concordance was obtained in blood grouping determinations (ABO/D/C/E/c/e/K, 0.04%‐0.22% discrepancies). Analysis of the discrepancies showed that Erytra provided the correct result in 51 of them (60%), with only five false negatives (one O patient transplanted with A, one mixed‐field reaction in a very weak D, one anti‐Vel, two A2rr). Erytra results were 100% reproducible in a series of 3760 repetition tests. CONCLUSION Grifols' Erytra analyzer showed reliable efficacy compared with equivalent FDA‐licensed reagents and FDA‐cleared instruments.