Evaluation of Erytra® fully automated analyser for Routine Use in Transfusion Laboratory

Abstract

To evaluate efficiency and performance of Erytra® analyser in comparison to the reference platform of the NBT immunohaematology laboratory (Bio-Rad ID-System). Moving to automation or semi-automation is a major focus of transfusion centres. The Erytra® (Grifols) is a new fully automated walk-away analyser with high volume processing capacity for pre-transfusion testing, designed to be used with the unique 8-column DG Gel® cards. A total of 2201 immunohaematological tests (1041 ABO/D grouping, 1041 antibody screening, 51 antibody identification, 45 newborns (ABO/D and DAT) and 23 crossmatches were performed on 1160 donor/patient whole blood samples. Erytra®'s performance was assessed by means of a stress test replicating the routine work of a hospital laboratory. Concordant results between the Erytra® and the reference method were obtained in 2195 (99·73 %) of the tests. There were only three discrepancies out of 6246 reactions (0·05%) in ABO/D grouping, all in the reverse group which did not mislead to group identification. Of the 1041 samples screened for antibody presence, Erytra® detected all the relevant antibodies [9 not detected weak prophylactic anti-D were determined to be clinically nonsignificant (<0·1 IU mL(-1) )] while Bio-Rad ID-System missed one anti-e and one anti-Jk(a) . Concordance for D grouping, crossmatching and newborns was 100%. Results of the simulated stress test exercise highlighted the capacity of Erytra® for absorbing into 4 h workloads equivalent to 24 h of routine. Grifols' Erytra® analyser showed reliable high sensitivity, velocity and capacity to cope with high workload in the immunohaematology laboratory routine.