1018-LBP: Comparative study of biofortuna sspgo hla typing product (IUO/PEO)

Aim This study compares the relative merits of a new HLA typing product soon to be available to laboratories in the USA – Biofortuna SSPGo HLA typing reagents marketed by Abbott to HLA typing reagents currently used in our laboratory. Evaluation points include reagent storage, ease of running the assay, reliability of the reagents, and comparability to established products. In a double-blinded study, we used the DNA of 100 patients, whose HLA antigens were well defined using lab-established SSO and/or SSP technologies. These patient HLA antigens covered 99% of all serologically defined HLA-A, B, C, DR and DQ antigens. Methods HLA testing using the SSPGo typing reagents for Class I and Class II antigens were per manufacturer’s instructions using standard protocols. Shipment and storage of reagents were at ambient temperature. Results of the SSPGo typings were performed manually using manufacturer provided worksheets and also using the Biofortuna Verdict Interpretation software provided. Results The time needed to perform the SSPGo HLA typing was comparable to the time needed to perform HLA typing using established reagents. The Verdict software was easy to use and 100% accurate as compared to manual analysis. The concordance of HLA typing results between SSPGo HLA typing reagents and those in current use in our laboratory was 98% for Class I reagents, and 99% for Class II reagents. The failure rate of the SSPGo reagents was 0.3% overall. The ambiguity rate was 0.1%. Conclusions The Biofortuna SSPGo HLA typing reagents had the advantage of room temperature shipping and storage conditions, which is extremely helpful in laboratories short on freezer space. Their testing was comparable to established laboratory protocols in ease of use and time of set-up and interpretation, and was comparable in both HLA Class I and Class II typing results and ambiguity rates to what we are currently using in our laboratory. The SSPGo reagents had a slightly lower failure rate than what we are currently using.