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.