(P-TS-136) Validating and Correlating with Intra-assay Precision of Eluate Testing Across Platforms and Methods, Including Bio-Rad Laboratories’ IH-1000 Fully Automated Gel Column Agglutination Analyzer

Background/Case Studies: : In Transfusion Medicine Laboratories, automation of testing of multiple methods is essential, where applicable. The ability to automate antibody identification panel testing on multiple eluate testing kits will save the laboratory much needed time for other pressing tasks.

Study

Design/Methods: To standardize workflows and enhance operational efficiency, Children’s National Hospital conducted a validation and intra-assay precision correlation of eluate testing from manual tube methods to manual gel column agglutination, and further to Bio-Rad’s IH-1000 fully automated Transfusion Medicine gel column agglutination analyzer. Hemobioscience’s HBS-Elution Kit, as well as Alba’s Acid Elution Kit was used to elute antibodies from patient intact red blood cells. Unbound antibody was removed by washing the coated RBCs with an acid solution which prevents the loss of adsorbed antibody from the red blood cells. After washing, the antigen-antibody complex is broken by the addition of a low pH solution, then the recovered eluate is adjusted to pH 7.0 ± 0.5 by adding a buffering solution. Once the elution was completed, an antibody screen was tested on an aliquot of the supernatant from the last wash to ensure that antibody present in the eluate had been eluted from the RBCs and was not remaining due to inadequate washing. 10 eluate samples were then tested for antibody screens and identification panels and correlated to the following methods: manual tube using Werfen, manual and automated gel-column agglutination (Bio-Rad Laboratories, Inc.). The test of record was the traditional tube testing method.

Results/Findings: : There was 100% correlation between and across all testing methods with the original traditional tube testing method of record. The following antibodies were identified in all the eluted samples (Anti-c (2), Anti-Fya (2), Anti-E/-c, Pan-agglutinin (2), in which antibody had been present in the patient plasma, as well as multiple negative samples (3). Automating the performance of the antibody identification panel testing allowed the technologists to walk away after performing the elution and return to the analyzer once testing had been completed for result review and interpretation.

Conclusions: Using Bio-Rad’s Data Management Software (along with the IH-1000 analyzer) allows standardization of result interpretation as well as digitally retained result images for reference. By validating and correlating intra-assay precision with a range of methods and acid elution kits, laboratories can achieve greater productivity. Automation introduces greater efficiency and standardization to elution testing, a process that is often labor-intensive and subjective. By automating eluate antibody identification testing, laboratory technologists can redirect valuable time to other critical tasks.