Evaluation of the Automated Blood Bank Systems IH-500 and VISION Max for ABO-RhD Blood Typing and Unexpected Antibody Screening

ABSTRACT

BACKGROUND: The use of automated systems for pre-transfusion tests is increasing in an attempt to reduce workload and the impact of human errors in blood banks. We evaluated the clinical performance of the automated blood bank systems IH-500 (Bio-Rad Laboratories, Switzerland) and VISION Max (Ortho-Clinical Diagnostics, USA) for ABO-RhD blood typing and unexpected antibody screening. METHODS: ABO-RhD blood typing was performed for 410 samples, and antibody screening was performed for 332 samples, including 15 antibody-positive samples. The results obtained from the two automated instruments were compared with those obtained using manual methods for ABO-RhD blood typing and a semiautomated method (DiaMed-ID system) for antibody screening. Additionally, both instruments were evaluated in terms of concordance rates, sensitivity, and carryover. RESULTS: The concordance rate of the ABO-RhD blood typing results between the manual methods and the two automated instruments was 100%. For antibody screening tests, the concordance rates between the semiautomated method (DiaMed-ID system) and the automated methods were 100% and 99.7% for the IH-500 and VISION Max instruments, respectively. The sole discrepant result was obtained for a sample identified as antibody-positive only on the VISION Max; the antibody was identified as anti-Le(a). The overall sensitivity of the two automated instruments was the same as or higher than that of the semiautomated method. Carryover was not observed in antibody screening. CONCLUSIONS: The IH-500 and VISION Max instruments showed reliable results for ABO-RhD blood typing and unexpected antibody screening, and can be used clinically, with confidence, for pre-transfusion tests in the blood bank.