B-043 Clinical performance evaluation of the ABD PAD® as confirmatory testing of blood group

Abstract Background Ensuring patient safety during transfusions is vital. Confirming blood type before transfusion is necessary to ensure the correct blood unit is given to the right patient. Traditional confirmation methods are time-consuming and use significant materials. The ABD PAD® device by Diagast offers a more efficient alternative, confirming blood type in under 30 seconds with minimal materials using the M-TRAP® methodology. This method detects antigen-antibody interactions on a porous membrane with pre-fixed antibodies. The study aimed to evaluate the concordance between the ABD PAD® and the conventional tube technique for ABO and Rh blood group confirmation. Methods This study assessed the performance of the ABD PAD® device for blood type confirmation, comparing it to the conventional tube method at Fundación Santa Fe de Bogotá. It was a quantitative diagnostic test study, evaluating blood type concordance. Seventy-five patients requiring transfusions participated. Blood type confirmation followed standard procedures, using the tube method first, followed by ABD PAD®, while measuring the time for each. To validate the results from ABD PAD®, additional tests with the Diamed card system and semi-automated IH-500 BioRad equipment were performed. This system is widely recognized for its precision, serving to confirm the results from both the conventional method and ABD PAD®. Blood samples were processed according to standard procedures, ensuring reliable results and providing a reference for comparison. The results from both methods were analyzed for concordance, with discrepancies investigated to assess the feasibility of ABD PAD® as a rapid and reliable alternative. User satisfaction was also evaluated, and concordance was analyzed using Cohen’s Kappa index, with interpretations based on Landis & Koch (1977). A paired t-test (p < 0.05) was used to compare the mean processing times and identify significant differences between the methods. Results A total of 75 samples were compared using both methods. Patients were randomly selected between April and May 2022. All results obtained from ABD PAD® were consistent with those from the conventional tube technique, resulting in a kappa index of 1. The p-value was 0.0, indicating a highly significant difference between the methods. Blood typing results showed 82.7% (62) O positive, 13.3% (10) A positive, 2.7% (2) B positive, and 1.3% (1) A negative. Four users conducted the tests, all of whom found the ABD PAD® technique easier due to fewer supplies required. They also noted the stability of the reagents, which can be stored at room temperature, making them suitable for use outside of clinical settings. Conclusion The study demonstrates that the ABD PAD® device is a reliable and efficient alternative for ABO and Rh blood group confirmation. The perfect agreement between ABD PAD® and the conventional method confirms the accuracy of this rapid test. Furthermore, the significant difference in processing times highlights ABD PAD®*s ability to deliver faster results. User feedback showed a clear preference for ABD PAD® due to its ease of use, reduced material requirements, and reagent stability. The ABD PAD® is a valuable tool for improving transfusion safety and efficiency in diverse clinical environments.