Multicenter evaluation of a high-throughput microarray platform for extensive red blood cell phenotyping and antibody screening.

Background: Blood typing and antibody screening are key elements of transfusion safety. However, available single platform, flexible, and affordable technologies are limited, especially for extended phenotyping. Microarray-based technology allows for this extended phenotyping with the flexibility of piecemeal analysis.

Study Design And Methods: This study was conducted in three blood donor laboratories to determine the performance of a high-throughput microarray-based system for ABO, RH1-RH5, and KEL1 typing, ABS and extended phenotyping (RH8, KEL2&3, FY1&2, JK1, MNS3). Specimens were tested simultaneously on local platforms and on the microarray-based system. When discrepancies were identified, resolver testing were performed.

Results: In total, 4862 blood samples were tested for standard phenotype, 4257 for antibody screening and 2194 for extended phenotype. Results were available for 92.12% of the samples. The overall percent agreements were: 100% for ABO, 99.8% for RH1, 99.24% for RH2-5 and 99.86% for KEL1, 93.16% for antibody screening, and 99.68% for extended phenotype.

Conclusions: This microarray-based system provides highly comparable results to current CE marked assays. The ability to continuously test 3000 microarrays in 1 day, providing simultaneously both extended RBC phenotyping and antibody detection drives laboratory efficiencies. The results of our study validate the performance of this new technology; however, the percentage of samples without results must be reduced and further analysis is required to interpret the ABS screening performances. This could constitute a real breakthrough in transfusion, making it possible in the long term, on a single platform, to carry out all the analyses necessary for the qualification of donations.