Background/Case Studies: The Bio‑Rad IH‑500 automated blood bank analyzer with its complementary IH‑Com Data Management System (DMS) is a fully automated, random access blood bank analyzer. The Bio‑Rad IH‑System consists of 21 FDA licensed Column Agglutination Technology (CAT) gel cards for use in immunohematology serological testing. Clinical studies were performed at three U.S. facilities. The purpose of this study was to evaluate the performance of the Bio‑Rad IH‑500 analyzer with IH‑Com DMS for blood grouping including ABO/Rh, weak D, Rh and K phenotyping. The results were compared with results generated by the IH‑1000, an FDA licensed blood bank analyzer, using the same IH‑Cards and reagents.
Study Design/Methods: Patient and donor samples were obtained from the three U.S. Blood Centers & Transfusion Medicine facilities. The study included the evaluation of IH‑Cards and results tested on the IH‑500 in comparison to the FDA‑licensed IH‑1000. A total of 1439 samples were tested. The assays evaluated were: ABO/Rh forward & reverse blood grouping, ABO/Rh forward only donor confirmation, Anti‑A,B Testing, RhD typing with direct agglutinating Anti‑D (including detection of partial DVI phenotypes), weak D, and Rh & K phenotyping). The percent agreement between the IH‑500 and the IH‑1000 was calculated for each reagent along with the Lower Confidence Limit. When quantity allowed, samples discrepant between the two analyzers were sent to a referee lab for testing with different licensed serological and/or molecular methods.
Results/Findings: The data table below summarizes the results, which demonstrated 100% full concordance for all IH‑Card testing. One sample reacted positive (dual population) with A1 RRBCs on IH‑500 resulting in an ABO discrepancy. In repeat testing to resolve, the A1 cell resulted negative and concordant with the reference method. There was insufficient volume for resolution testing at the referee lab. Nine samples reacted positive with B RRBCs on the IH‑500. Eight samples resulted as blood group A and confirmed true positive on the IH‑500.
Conclusion: Out of the 1439 samples tested, 552 resulted negative by both the IH‑500 and the IH‑1000. One sample resulted negative with the IH‑500 only. All 886 had positive agreement with both the IH‑1000 and the IH‑500. The positive percent agreement (PPA) is 886/886 or 100%, while the negative percent agreement (NPA) is 552/553 or 99.82%. The evaluation of Bio‑Rad’s IH‑500 automated blood bank analyzer demonstrated full concordance to the FDA licensed IH‑1000.